Invited to participate to CLINICAL TRIAL of # XL147 at Fox Chase in Philly!

lindaprocopio
lindaprocopio Member Posts: 1,980
edited March 2014 in Uterine Cancer #1
I received a call today from Dr. Mark Morgan at Fox Chase Cancer Center in Philadelphia offering me the opportunity to participate in a clinical trial: ( http://clinicaltrials.gov/ct2/show/NCT01013324 ). The trial is in PHASE 2 and is for recurrent endometrial cancer, for drug # XL147. Dr. Morgan said that if I am ever going to try something "cutting edge" & do a clinical trial, it should be now while I still feel pretty healthy and am having no real physical symptoms. Apparently XL147 is a pill that blocks P-110 pathways (???) and has minimal side effects (sometimes a rash & diahrea). I would have to go down to Fox Chase every 2 weeks for labs (about 2 1/2 hours each way). I'm to call within a week if I want to enroll.

Meanwhile I am having a MUGGA scan tomorrow afternoon in preparation for possibly starting to take Doxil. & Monday I have an appointment scheduled with my radiation oncologist to talk about the recommended radiation of those 2 malignant nodes suggested by Fox Chase when I was down there for a 2nd opinion. If I do this Clinical Trial, I have to put off radiation and Doxil until later. I'm tempted to do the trial, but welcome feedback here from any of you. I'm thinking that there are only so many chemos for endomatrial cancer and once you've taken them all until each is no longer effective, what then? So this gives me a shot at a NEW drug that I wouldn't be able to get otherwise. & it just could be "the one". & if it doesn't work after a couple of months, I can always drop out and get back into conventional treatment.

Anyone see a down side I'm missing?
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Comments

  • Songflower
    Songflower Member Posts: 608
    Clinical Trial
    I did a clinical trial with my breast cancer 11 years ago. I would research the drug some more. They will follow you closely; if it doesn't seem to be working you can easily switch back to chemo.

    Would you be getting the drug or a placebo? I think this would be the most important question to ask yourself. Does it matter what type of endometrial cancer? I am trying to think of questions to ask to help you make up your mind. Of course, this is coming from the gal who just had HIPEC and will go into chemo again for final phase. All data is gathered for research.

    I just read a very interesting article in current Newsweek; they believe multiple drug therapy is better than single chemo agents. This was first discovered on pediatric patients that are treated agressively. Very good reading; I often believed that those of us that are not a 1a need more agressive treatment for a longer period. It only makes sense. I also think we need intraperitoneal chemo and intraveinous. I'm learning alot; sometimes I wonder if the oncologists are really thinking about this and seeing the logic. With pediatric patients chemo is sometimes given for two years. They have attained high cure rates.

    We're with you through your decision.

    Diane
  • maggie_wilson
    maggie_wilson Member Posts: 596
    linda and clinical trial l

    linda,

    i'm so glad you are being given the opportunity to decide whether you want to do this trial or not. i have only one question: does everyone in the trial get this same drug, or do half the participants get the drug they are testing, and the other half get a placebo, and neither half knows which it's getting?? that's my only concern. if that happens to be the case, i don't think, if it were me, i'd do it.

    if, however, you know you'll get the drug that's being tested, it does sound like it's worth doing; and as you say, if it doesn't work for you, you can always drop out and go back to conventional treatment. it's a big decision, but it's great to have options....

    so, whatever you decide, dear linda, we're100% behind you.

    hugs and sisterhood,
    maggie
  • Clinical Trial
    I did a clinical trial with my breast cancer 11 years ago. I would research the drug some more. They will follow you closely; if it doesn't seem to be working you can easily switch back to chemo.

    Would you be getting the drug or a placebo? I think this would be the most important question to ask yourself. Does it matter what type of endometrial cancer? I am trying to think of questions to ask to help you make up your mind. Of course, this is coming from the gal who just had HIPEC and will go into chemo again for final phase. All data is gathered for research.

    I just read a very interesting article in current Newsweek; they believe multiple drug therapy is better than single chemo agents. This was first discovered on pediatric patients that are treated agressively. Very good reading; I often believed that those of us that are not a 1a need more agressive treatment for a longer period. It only makes sense. I also think we need intraperitoneal chemo and intraveinous. I'm learning alot; sometimes I wonder if the oncologists are really thinking about this and seeing the logic. With pediatric patients chemo is sometimes given for two years. They have attained high cure rates.

    We're with you through your decision.

    Diane

    This comment has been removed by the Moderator
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  • kkstef
    kkstef Member Posts: 688

    linda and clinical trial l

    linda,

    i'm so glad you are being given the opportunity to decide whether you want to do this trial or not. i have only one question: does everyone in the trial get this same drug, or do half the participants get the drug they are testing, and the other half get a placebo, and neither half knows which it's getting?? that's my only concern. if that happens to be the case, i don't think, if it were me, i'd do it.

    if, however, you know you'll get the drug that's being tested, it does sound like it's worth doing; and as you say, if it doesn't work for you, you can always drop out and go back to conventional treatment. it's a big decision, but it's great to have options....

    so, whatever you decide, dear linda, we're100% behind you.

    hugs and sisterhood,
    maggie

    I did look into a clinical trial when first diagnosed. The individuals are randomly assigned so you have no idea if you are on the new drug or getting a placebo. When I read about the potential side effects of the drug and my personal health history, I decided NOT to participate. My oncologist concurred.

    So make sure you understand all of the lengthy verbiage!

    Not an easy decision and I know you will make the best decision for YOU!

    Best wishes...Karen
  • lociee
    lociee Member Posts: 102
    kkstef said:

    I did look into a clinical trial when first diagnosed. The individuals are randomly assigned so you have no idea if you are on the new drug or getting a placebo. When I read about the potential side effects of the drug and my personal health history, I decided NOT to participate. My oncologist concurred.

    So make sure you understand all of the lengthy verbiage!

    Not an easy decision and I know you will make the best decision for YOU!

    Best wishes...Karen

    New Yorker Article
    Hi Linda - something that I found interesting - you may, too, is an article in the August 2, 2010 New Yorker - Annals of Medicine - what I found most interesting was the info on Stephen J. Gould (who lived around the corner from me in Cambridge for years - before he moved to new york), he talks about the fighting "until the skein runs out" - I love that image! - and "those who rage mightily against the dying of the light." Overall the article was sad - but at the same time reaffirming and uplifting. I recommend you read it - they talk a lot about trials and the TIME - trials give - or do not give.
  • lindaprocopio
    lindaprocopio Member Posts: 1,980
    kkstef said:

    I did look into a clinical trial when first diagnosed. The individuals are randomly assigned so you have no idea if you are on the new drug or getting a placebo. When I read about the potential side effects of the drug and my personal health history, I decided NOT to participate. My oncologist concurred.

    So make sure you understand all of the lengthy verbiage!

    Not an easy decision and I know you will make the best decision for YOU!

    Best wishes...Karen

    Single Arm: Experimental (ALL trial participants get XL147 drug)
    This is a single arm trial which means all participants (88 expected) get the XL147; there is no control group getting a placebo. This clinical trial is to show the "Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months", and "Duration of response and PFS". Apparently this drug is being tested on a variety of different cancers that are known to have mutations/amplification in the PIK3CA gene (like endometrail cancer), each type of cancer in a different clinical trial.

    I think I'll call the phone number Fox Chase provided to talk to the person that insures "informed consent" of all participants, once I hear back from my own local oncology team on how they feel about me doing this. It sounds exciting to be a part of, but I don't want to be foolish or do it for the wrong reasons (like... no expected nausea, fatigue, or baldness,.... which all sound PRETTY TEMPTING!) I want to make a decision soon and get back in treatment of some kind within the next 10 days if possible. I've been out of chemo for a full month now getting that CT/PET, meeting with my 2 local oncologists, & then getting that 2nd opinion at Fox Chase. A month is a long time to be out of treatment when you have confirmed active cancer, and I don't want to hem and haw over this for weeks. I'm moving forward on ALL my options (MUGGA scan tomorrow in case I do the Doxil chemo; plus apppointment with radiation oncologist on Monday in case I do targeted radiation of those 2 cancerous nodes; plus emails sent out to my 3 oncologists for feedback on this clinical trail in case I do THAT!)

    Maybe this clinical trial is the BOLD MOVE I was looking for, a chance to change the course of my prognosis, a chance to be a part of a new way of treating recurrent uterine cancer. Or maybe not! HA!
  • kansasgal
    kansasgal Member Posts: 122 Member
    What to do, what to do?
    Following my hysterectomy in late April 2009 and subsequent Dx of stage 1A UPSC in late May 2009, I traveled 2 ½ hours one-way to another state for a second-opinion consultation with Dr. D. Scott McMeekin at the Oklahoma University Cancer Institute. I was trying to make a decision on adjuvant therapy and had been referred to Dr. McMeekin by an oncologist at the Mayo Clinic. I arranged for the blocks with my slides to be sent to Dr. McMeekin before my visit. At my visit he recommended that I seriously consider adding vaginal brachytherapy to the 6 rounds of carbo/taxol recommended by my local gyn/onc. He also told me about a clinical trial he was conducting for which he felt I would qualify. He urged me to read more about it (he gave me a packet of info) and to let him know right away if I wished to be considered since treatment would need to commence immediately.

    (Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer – still recruiting participants – GOG-0249 – NCT00807768)

    Like Karen, I carefully considered taking part in a clinical trial but felt that my medical history (which includes a lengthy history of severe diverticular disease) made pelvic radiation of too great a risk for me to take the chance of being randomly assigned to that arm of the clinical trial – especially with my cancer caught at such an early stage. I decided to hold the pelvic radiation option in reserve in the event that a pelvic recurrence might warrant the 25-30 rounds of pelvic radiation at the risk of perforating my already fragile intestines. I did, however, request of my local gyn/onc that vaginal vault brachytherapy be added to my treatment, and he facilitated with a referral to the rad/onc. I also was strongly encouraged by several other oncologist friends to have chemotherapy as my primary adjuvant therapy rather than taking a chance on radiation alone as adjuvant therapy.

    Your situation looks different to me. Of course no one has a crystal ball, but the members of your current local oncology team seems very interested in YOU (not just your case), so I would definitely seek their opinion as you are making up your mind how to proceed. And to me the single arm aspect makes the decision process much less murky.

    I really wished I could have taken part in a clinical trial as part of my initial adjuvant therapy since I feel they are so vital to selecting the best protocols for future patients.

    Hugs from Sally
  • maggie_wilson
    maggie_wilson Member Posts: 596

    Single Arm: Experimental (ALL trial participants get XL147 drug)
    This is a single arm trial which means all participants (88 expected) get the XL147; there is no control group getting a placebo. This clinical trial is to show the "Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months", and "Duration of response and PFS". Apparently this drug is being tested on a variety of different cancers that are known to have mutations/amplification in the PIK3CA gene (like endometrail cancer), each type of cancer in a different clinical trial.

    I think I'll call the phone number Fox Chase provided to talk to the person that insures "informed consent" of all participants, once I hear back from my own local oncology team on how they feel about me doing this. It sounds exciting to be a part of, but I don't want to be foolish or do it for the wrong reasons (like... no expected nausea, fatigue, or baldness,.... which all sound PRETTY TEMPTING!) I want to make a decision soon and get back in treatment of some kind within the next 10 days if possible. I've been out of chemo for a full month now getting that CT/PET, meeting with my 2 local oncologists, & then getting that 2nd opinion at Fox Chase. A month is a long time to be out of treatment when you have confirmed active cancer, and I don't want to hem and haw over this for weeks. I'm moving forward on ALL my options (MUGGA scan tomorrow in case I do the Doxil chemo; plus apppointment with radiation oncologist on Monday in case I do targeted radiation of those 2 cancerous nodes; plus emails sent out to my 3 oncologists for feedback on this clinical trail in case I do THAT!)

    Maybe this clinical trial is the BOLD MOVE I was looking for, a chance to change the course of my prognosis, a chance to be a part of a new way of treating recurrent uterine cancer. Or maybe not! HA!

    that's great news re: single arm: experimental

    linda,

    the more i thought about it, the more i thought that they would not have a control group with cancers that are recurrent; would be too risky. so very glad to hear everyone gets the same drug, no worries there. i think that it's smart to keep all your options open until you make a decision, and certainly you'd want to hear what your 3 oncologists have to say re: this trial. i bet they're in favor of it. i agree, this possibility does sound very exciting. if you're able to remember your dreams, it could be a really instructive time to learn what your unconscious is thinking, so if you can, write your dreams down and listen to what they're saying. often our unconscious knows better what we want or need than our conscious thought. in any case, i'm hoping you soon have the information (from all possible sources) you need to make the best choice possible for yourself because i know how anxious you are to get started. and, linda, i honestly do not think you're going to make a decision based on the promise of no nausuea, fatique or baldness--just because this drug has some additional good things going for it, doesn't mean it's not still the best choice. and, there's no question this clinical trial is a bold move!

    so, hang in there, girlfriend, and know we're solidly behind you.

    hugs and sisterhood,
    maggie
  • Songflower
    Songflower Member Posts: 608
    kansasgal said:

    What to do, what to do?
    Following my hysterectomy in late April 2009 and subsequent Dx of stage 1A UPSC in late May 2009, I traveled 2 ½ hours one-way to another state for a second-opinion consultation with Dr. D. Scott McMeekin at the Oklahoma University Cancer Institute. I was trying to make a decision on adjuvant therapy and had been referred to Dr. McMeekin by an oncologist at the Mayo Clinic. I arranged for the blocks with my slides to be sent to Dr. McMeekin before my visit. At my visit he recommended that I seriously consider adding vaginal brachytherapy to the 6 rounds of carbo/taxol recommended by my local gyn/onc. He also told me about a clinical trial he was conducting for which he felt I would qualify. He urged me to read more about it (he gave me a packet of info) and to let him know right away if I wished to be considered since treatment would need to commence immediately.

    (Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer – still recruiting participants – GOG-0249 – NCT00807768)

    Like Karen, I carefully considered taking part in a clinical trial but felt that my medical history (which includes a lengthy history of severe diverticular disease) made pelvic radiation of too great a risk for me to take the chance of being randomly assigned to that arm of the clinical trial – especially with my cancer caught at such an early stage. I decided to hold the pelvic radiation option in reserve in the event that a pelvic recurrence might warrant the 25-30 rounds of pelvic radiation at the risk of perforating my already fragile intestines. I did, however, request of my local gyn/onc that vaginal vault brachytherapy be added to my treatment, and he facilitated with a referral to the rad/onc. I also was strongly encouraged by several other oncologist friends to have chemotherapy as my primary adjuvant therapy rather than taking a chance on radiation alone as adjuvant therapy.

    Your situation looks different to me. Of course no one has a crystal ball, but the members of your current local oncology team seems very interested in YOU (not just your case), so I would definitely seek their opinion as you are making up your mind how to proceed. And to me the single arm aspect makes the decision process much less murky.

    I really wished I could have taken part in a clinical trial as part of my initial adjuvant therapy since I feel they are so vital to selecting the best protocols for future patients.

    Hugs from Sally

    Thinking about you
    Dear Linda,

    I have been reading "Curing Cancer" in NEWSWEEK Sept 13, 2010. They are discussing new oral drugs that will change the face of treating cancer. they work on "driver mutations." It is so exciting.

    Some oncologists complain that our group doesn't try enough clinical research. I think you should read this article. It's probably the direction they're going to. I know when I relapsed with cancer in the peritoneum I called MD Andersen and she had wanted me to do some oral drug but it was closed. Look at what Gleevec has done for leukemia.

    Sometimes we do clinical trials to get the cutting edge medication. I first did it for my daughters. Then I felt like I did it for all my sisters with breast cancer. I am not that altruistic but you at least feel that you did something to help. I don't regret it one minute. I don't think they would endanger you. My experience is they give what they really believe works.

    Please read the article in Newsweek. The oral drugs are sounding more on the right track from the article.

    I don't want to push you. I'd take it but I am already in the HIPEC thing and wouldn't qualify. Sometimes you have to take a chance on life.
  • kkstef
    kkstef Member Posts: 688
    kansasgal said:

    What to do, what to do?
    Following my hysterectomy in late April 2009 and subsequent Dx of stage 1A UPSC in late May 2009, I traveled 2 ½ hours one-way to another state for a second-opinion consultation with Dr. D. Scott McMeekin at the Oklahoma University Cancer Institute. I was trying to make a decision on adjuvant therapy and had been referred to Dr. McMeekin by an oncologist at the Mayo Clinic. I arranged for the blocks with my slides to be sent to Dr. McMeekin before my visit. At my visit he recommended that I seriously consider adding vaginal brachytherapy to the 6 rounds of carbo/taxol recommended by my local gyn/onc. He also told me about a clinical trial he was conducting for which he felt I would qualify. He urged me to read more about it (he gave me a packet of info) and to let him know right away if I wished to be considered since treatment would need to commence immediately.

    (Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer – still recruiting participants – GOG-0249 – NCT00807768)

    Like Karen, I carefully considered taking part in a clinical trial but felt that my medical history (which includes a lengthy history of severe diverticular disease) made pelvic radiation of too great a risk for me to take the chance of being randomly assigned to that arm of the clinical trial – especially with my cancer caught at such an early stage. I decided to hold the pelvic radiation option in reserve in the event that a pelvic recurrence might warrant the 25-30 rounds of pelvic radiation at the risk of perforating my already fragile intestines. I did, however, request of my local gyn/onc that vaginal vault brachytherapy be added to my treatment, and he facilitated with a referral to the rad/onc. I also was strongly encouraged by several other oncologist friends to have chemotherapy as my primary adjuvant therapy rather than taking a chance on radiation alone as adjuvant therapy.

    Your situation looks different to me. Of course no one has a crystal ball, but the members of your current local oncology team seems very interested in YOU (not just your case), so I would definitely seek their opinion as you are making up your mind how to proceed. And to me the single arm aspect makes the decision process much less murky.

    I really wished I could have taken part in a clinical trial as part of my initial adjuvant therapy since I feel they are so vital to selecting the best protocols for future patients.

    Hugs from Sally

    I really didn't mean one group would receive a placebo, but rather there would be two groups and each participaant assigned to one of the 2 treatmenst protocol and compared. The one "arm" of the protocol for the trial I was considering I felt was too risky for me and since there is a 50-50 chance of being put in that group, it was too big a risk for me.

    I agree a single arm is different. I know you will gather all of the info you can, and evaluate your options and make the choice that you feel is best for YOU!

    Best wishes! Karen
  • MoeKay
    MoeKay Member Posts: 402 Member
    kkstef said:

    I really didn't mean one group would receive a placebo, but rather there would be two groups and each participaant assigned to one of the 2 treatmenst protocol and compared. The one "arm" of the protocol for the trial I was considering I felt was too risky for me and since there is a 50-50 chance of being put in that group, it was too big a risk for me.

    I agree a single arm is different. I know you will gather all of the info you can, and evaluate your options and make the choice that you feel is best for YOU!

    Best wishes! Karen

    Sounds Very Exciting, Linda!
    Here are some questions that came to mind. Will you have to wait for 6 months for a scan to see if the XL 147 is working or will they do scans more frequently? What was the dropout rate in Phase 1 and what were the reasons? How many people were given XL 147 in the Phase 1 trial, what types of tumors did they have, and what type of tumor activity did they see? How well is Doxil known to work on UPSC? Would any of the potential side effects from the XL 147 potentially preclude your doing Doxil or other chemo in the future?

    After I was diagnosed with eosinophilic pneumonia last fall, I had to try to figure out what to do when the two pulmonologists I saw were recommending very different doses of prednisone (one 3 times as great as the other) as well as very different follow-up. There have been no randomized clinical trials because the disease is so rare, but from what I had read, many doctors started patients in the 40-60 mg./day dose range. I was reluctant to take such a high dose for the number of months I knew I would be on the drug. So I emailed an eosinophil expert (there is none exclusively for eosinophilic pneumonia because the disease is so rare). While he had a third recommendation for treatment, the invaluable information he provided assisted me in making my decision. I ended up going with the lower dose, and it did clear up my EP, although I still ended up with a stress fracture in my hip and femur due to the prednisone. But imagine if I had gone with a dose 3 times as high! I feel I was able to make the best decision for me because I sought out the best minds to assist in my decision-making process. So I wonder if there might be someone who has in-depth knowledge about XL 147 that you could call or email? Perhaps the researchers from the Phase 1 trial? I feel that information is power, and the more you can learn about this drug as well as the Doxil which will be your treatment if you decline to participate, the more well-informed your decision is likely to be.

    Good luck, whatever you decide, Linda!

    MoeKay/Maureen
  • thank you
    thank you Member Posts: 77

    Single Arm: Experimental (ALL trial participants get XL147 drug)
    This is a single arm trial which means all participants (88 expected) get the XL147; there is no control group getting a placebo. This clinical trial is to show the "Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months", and "Duration of response and PFS". Apparently this drug is being tested on a variety of different cancers that are known to have mutations/amplification in the PIK3CA gene (like endometrail cancer), each type of cancer in a different clinical trial.

    I think I'll call the phone number Fox Chase provided to talk to the person that insures "informed consent" of all participants, once I hear back from my own local oncology team on how they feel about me doing this. It sounds exciting to be a part of, but I don't want to be foolish or do it for the wrong reasons (like... no expected nausea, fatigue, or baldness,.... which all sound PRETTY TEMPTING!) I want to make a decision soon and get back in treatment of some kind within the next 10 days if possible. I've been out of chemo for a full month now getting that CT/PET, meeting with my 2 local oncologists, & then getting that 2nd opinion at Fox Chase. A month is a long time to be out of treatment when you have confirmed active cancer, and I don't want to hem and haw over this for weeks. I'm moving forward on ALL my options (MUGGA scan tomorrow in case I do the Doxil chemo; plus apppointment with radiation oncologist on Monday in case I do targeted radiation of those 2 cancerous nodes; plus emails sent out to my 3 oncologists for feedback on this clinical trail in case I do THAT!)

    Maybe this clinical trial is the BOLD MOVE I was looking for, a chance to change the course of my prognosis, a chance to be a part of a new way of treating recurrent uterine cancer. Or maybe not! HA!

    Does the study give you more HOPE?
    I think this is the most important - at least for me. We all hear that after the recurrence there is not much for cure. We hear statistics that we try to fight. And the already approved treatments are not so many. And all the approved drugs wills still be there if for some reason you couldn't continue the study.
    BUT isn't it what you needed? To try something new? to be hopefull that this might bring CURE?
    My experience with studies as a physician: I never ask a patient who has a good insurance and never tried the FDA approved meds to participate in the studies I am conducting. But I see many people with bad or no insurance at all. These patients, or patients that have tried everything approved but still don't do well participate in my studies. And I am very happy with how closely the patients are monitored. And all this for free - which is important for many patients.
    I would go for it. Before you sing the consent they can give you information about the phase I results. You can ask about side effects, percentages and how frequently you will be monitored, and how - this is very important because you want to withdraw early if it doesn't work for you and go to Doxil. We all know that at the end of the first visit you will know more than many oncologists about this study.
    New options and many alternatives are needed, and HOPE is certainly needed.

    Chrysoula
  • lindaprocopio
    lindaprocopio Member Posts: 1,980
    MoeKay said:

    Sounds Very Exciting, Linda!
    Here are some questions that came to mind. Will you have to wait for 6 months for a scan to see if the XL 147 is working or will they do scans more frequently? What was the dropout rate in Phase 1 and what were the reasons? How many people were given XL 147 in the Phase 1 trial, what types of tumors did they have, and what type of tumor activity did they see? How well is Doxil known to work on UPSC? Would any of the potential side effects from the XL 147 potentially preclude your doing Doxil or other chemo in the future?

    After I was diagnosed with eosinophilic pneumonia last fall, I had to try to figure out what to do when the two pulmonologists I saw were recommending very different doses of prednisone (one 3 times as great as the other) as well as very different follow-up. There have been no randomized clinical trials because the disease is so rare, but from what I had read, many doctors started patients in the 40-60 mg./day dose range. I was reluctant to take such a high dose for the number of months I knew I would be on the drug. So I emailed an eosinophil expert (there is none exclusively for eosinophilic pneumonia because the disease is so rare). While he had a third recommendation for treatment, the invaluable information he provided assisted me in making my decision. I ended up going with the lower dose, and it did clear up my EP, although I still ended up with a stress fracture in my hip and femur due to the prednisone. But imagine if I had gone with a dose 3 times as high! I feel I was able to make the best decision for me because I sought out the best minds to assist in my decision-making process. So I wonder if there might be someone who has in-depth knowledge about XL 147 that you could call or email? Perhaps the researchers from the Phase 1 trial? I feel that information is power, and the more you can learn about this drug as well as the Doxil which will be your treatment if you decline to participate, the more well-informed your decision is likely to be.

    Good luck, whatever you decide, Linda!

    MoeKay/Maureen

    Here's what I've read about Phase 1 and Phase 2 trials
    From what I understand, Phase 1 of a Clinical Trial is the FIRST time humans have taken the drug and is simply to make sure the drug is SAFE to take. Usually healthy people are PAID to take the drug; no sick people participate. If the drug doesn't show side affects in Phase 1, then Phase 2 is when a smallish sampling of a well-defined SICK population (88 pp. in this case) take the drug to see if it actually WORKS to slow or halt the targeted disease. The number of people involved has to be large enough that the data is relevant, but small enough that it is affordable for the researcher because the drug company is footing the bill for all the testing, monitoring, & they provide the drug free to the participants. In Phase 3 & 4 Trials the number of participants goes way way up, but now participant's private insurance is sometimes picking up the tab (for those with great insurance like mine). I've read that you have to be careful with Phase 3 Trials that you aren't stuck paying for the experimental drug personally out of pocket.

    Anyway, this is a Phase 2 trial. I wish it was a Phase 3 Trial because I think my insurance might have actually funded it (as they cover all CT/PETs, all Nuelasta, & anything else prescribed to date), and the drug would be further along in testing. But then again, my insurance may have denied covering an unapproved experimental drug, and then I'd have to pay out of pocket to participate. So maybe the smaller Phase 2 Trial is a lucky break for me after all since the drug company investors will be footing the bill and I still get to try something that is many years away from being FDA-approved. Maybe the stars are all aligned for me to do this.

    Thank you everyone for all input and support! I'll look for that magazine article. I really think I might do this trial!
  • MoeKay
    MoeKay Member Posts: 402 Member

    Here's what I've read about Phase 1 and Phase 2 trials
    From what I understand, Phase 1 of a Clinical Trial is the FIRST time humans have taken the drug and is simply to make sure the drug is SAFE to take. Usually healthy people are PAID to take the drug; no sick people participate. If the drug doesn't show side affects in Phase 1, then Phase 2 is when a smallish sampling of a well-defined SICK population (88 pp. in this case) take the drug to see if it actually WORKS to slow or halt the targeted disease. The number of people involved has to be large enough that the data is relevant, but small enough that it is affordable for the researcher because the drug company is footing the bill for all the testing, monitoring, & they provide the drug free to the participants. In Phase 3 & 4 Trials the number of participants goes way way up, but now participant's private insurance is sometimes picking up the tab (for those with great insurance like mine). I've read that you have to be careful with Phase 3 Trials that you aren't stuck paying for the experimental drug personally out of pocket.

    Anyway, this is a Phase 2 trial. I wish it was a Phase 3 Trial because I think my insurance might have actually funded it (as they cover all CT/PETs, all Nuelasta, & anything else prescribed to date), and the drug would be further along in testing. But then again, my insurance may have denied covering an unapproved experimental drug, and then I'd have to pay out of pocket to participate. So maybe the smaller Phase 2 Trial is a lucky break for me after all since the drug company investors will be footing the bill and I still get to try something that is many years away from being FDA-approved. Maybe the stars are all aligned for me to do this.

    Thank you everyone for all input and support! I'll look for that magazine article. I really think I might do this trial!

    Interim Data for XL 147
    Linda, here is a link to some interim data from Phase 1 and Phase 1b/2:

    http://www.news-medical.net/news/20100608/Interim-data-from-multiple-ongoing-trials-of-XL147-PI3K-inhibitor-to-be-presented-at-ASCO-2010.aspx
  • lindaprocopio
    lindaprocopio Member Posts: 1,980
    MoeKay said:

    Interim Data for XL 147
    Linda, here is a link to some interim data from Phase 1 and Phase 1b/2:

    http://www.news-medical.net/news/20100608/Interim-data-from-multiple-ongoing-trials-of-XL147-PI3K-inhibitor-to-be-presented-at-ASCO-2010.aspx

    All 3 local Oncs say "go for it", now it's about TIMING
    It's been a month now since my last chemo, even though I have active cancer and should be in treatment, so the TIME it takes to get me enrolled and actually receiving the drug is now the biggest roadblock to my participation in this Clinical Trial. Only my Gyne-Onc was bold enough to actually email and say "Do it!" right out, but my chemo-onc and radiation onc both emailed their approval in more vague terms (probably some concerns about lawsuits in how carefully they worded their go-aheads. ha!) But I've done my research and have decided I want to do this clinical trial IF (the big "IF") they can get me enrolled and in treatment again within the next 10 days or so. I am really afraid to have lost so much time on my 'next treatment' decision already, although Dr. Morgan and my local oncs both tell me that I should be okay and that I can invest this time to make an informed decision.

    The famous Dr. Morgan from Fox Chase surprised me by calling me AGAIN last evening to talk about the clinical trial. He is having the head researcher call me Monday to set up an appointment down there in Philly for my "Informed Consent" paperwork. They already have all my path reports and tissue slides, but will need my actual tissue BLOCK from my original surgery. A baseline CT/PET is required prior to entering the Trial, and there will be a rush to get me in so that the one I had on 8/19 will meet that requirement (a 30-day window, Dr. Morgan guessed but was unsure). They only allow 88 participants in this Trial worldwide (USA, Belgium, & France I think) but the inclusion parameters are so narrow with so many exclusions that an eligible participant, at exactly the right point in their treatments, must be a 'find', and statistically only 5% of cancer patients ever participate in a Clinical Trial for a lot of personal reasons. So I know they really want me. But if they can't get me quickly with that XK-147 pill in my mouth, I will be too anxious to wait. (I missed out on Da Vinci surgery way way back when my cancer was diagnosed because I was unwilling to lose an extra month before my surgery by switching hospitals and all the extra testing, etc. that usually triggers.) I like ACTION for my cancer battle and am anxious without it, I guess, when I am not in remission.

    Do you all want the step-by-step on the Clinical Trial posted? I don't want to bore you with this "all about me" tirade, but if you think it would be interesting and helpful for those that come after me who might consider a Trial, I'd be happy to share the process. If nothing else, I know I'll need your input as this rolls along.
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  • maggie_wilson
    maggie_wilson Member Posts: 596

    All 3 local Oncs say "go for it", now it's about TIMING
    It's been a month now since my last chemo, even though I have active cancer and should be in treatment, so the TIME it takes to get me enrolled and actually receiving the drug is now the biggest roadblock to my participation in this Clinical Trial. Only my Gyne-Onc was bold enough to actually email and say "Do it!" right out, but my chemo-onc and radiation onc both emailed their approval in more vague terms (probably some concerns about lawsuits in how carefully they worded their go-aheads. ha!) But I've done my research and have decided I want to do this clinical trial IF (the big "IF") they can get me enrolled and in treatment again within the next 10 days or so. I am really afraid to have lost so much time on my 'next treatment' decision already, although Dr. Morgan and my local oncs both tell me that I should be okay and that I can invest this time to make an informed decision.

    The famous Dr. Morgan from Fox Chase surprised me by calling me AGAIN last evening to talk about the clinical trial. He is having the head researcher call me Monday to set up an appointment down there in Philly for my "Informed Consent" paperwork. They already have all my path reports and tissue slides, but will need my actual tissue BLOCK from my original surgery. A baseline CT/PET is required prior to entering the Trial, and there will be a rush to get me in so that the one I had on 8/19 will meet that requirement (a 30-day window, Dr. Morgan guessed but was unsure). They only allow 88 participants in this Trial worldwide (USA, Belgium, & France I think) but the inclusion parameters are so narrow with so many exclusions that an eligible participant, at exactly the right point in their treatments, must be a 'find', and statistically only 5% of cancer patients ever participate in a Clinical Trial for a lot of personal reasons. So I know they really want me. But if they can't get me quickly with that XK-147 pill in my mouth, I will be too anxious to wait. (I missed out on Da Vinci surgery way way back when my cancer was diagnosed because I was unwilling to lose an extra month before my surgery by switching hospitals and all the extra testing, etc. that usually triggers.) I like ACTION for my cancer battle and am anxious without it, I guess, when I am not in remission.

    Do you all want the step-by-step on the Clinical Trial posted? I don't want to bore you with this "all about me" tirade, but if you think it would be interesting and helpful for those that come after me who might consider a Trial, I'd be happy to share the process. If nothing else, I know I'll need your input as this rolls along.

    linda, OF COURSE we want to know everything!

    they don't call me "no detail too small" for nothing. i want to hear everything, step-by-step as you go on this journey. i do hope you are enrolled in the protocal close to your time frame, because i wouldn't want you to miss out on what seems a very promising prospect. so glad your gyn-onc was fearless enough to just tell you to do it. wish more of our doctors were like that; and i do agree, the ones that aren't are no doubt covering their rear ends.

    i'm feeling very optomistic about this trial, linda, though all the procedures you need to go through beforehand seem a big drag; still it all seems worth it. so do keep us posted.

    waiting with bated breath for all the latest breaking news....

    sisterhood,
    maggie
  • Ro10
    Ro10 Member Posts: 1,561

    All 3 local Oncs say "go for it", now it's about TIMING
    It's been a month now since my last chemo, even though I have active cancer and should be in treatment, so the TIME it takes to get me enrolled and actually receiving the drug is now the biggest roadblock to my participation in this Clinical Trial. Only my Gyne-Onc was bold enough to actually email and say "Do it!" right out, but my chemo-onc and radiation onc both emailed their approval in more vague terms (probably some concerns about lawsuits in how carefully they worded their go-aheads. ha!) But I've done my research and have decided I want to do this clinical trial IF (the big "IF") they can get me enrolled and in treatment again within the next 10 days or so. I am really afraid to have lost so much time on my 'next treatment' decision already, although Dr. Morgan and my local oncs both tell me that I should be okay and that I can invest this time to make an informed decision.

    The famous Dr. Morgan from Fox Chase surprised me by calling me AGAIN last evening to talk about the clinical trial. He is having the head researcher call me Monday to set up an appointment down there in Philly for my "Informed Consent" paperwork. They already have all my path reports and tissue slides, but will need my actual tissue BLOCK from my original surgery. A baseline CT/PET is required prior to entering the Trial, and there will be a rush to get me in so that the one I had on 8/19 will meet that requirement (a 30-day window, Dr. Morgan guessed but was unsure). They only allow 88 participants in this Trial worldwide (USA, Belgium, & France I think) but the inclusion parameters are so narrow with so many exclusions that an eligible participant, at exactly the right point in their treatments, must be a 'find', and statistically only 5% of cancer patients ever participate in a Clinical Trial for a lot of personal reasons. So I know they really want me. But if they can't get me quickly with that XK-147 pill in my mouth, I will be too anxious to wait. (I missed out on Da Vinci surgery way way back when my cancer was diagnosed because I was unwilling to lose an extra month before my surgery by switching hospitals and all the extra testing, etc. that usually triggers.) I like ACTION for my cancer battle and am anxious without it, I guess, when I am not in remission.

    Do you all want the step-by-step on the Clinical Trial posted? I don't want to bore you with this "all about me" tirade, but if you think it would be interesting and helpful for those that come after me who might consider a Trial, I'd be happy to share the process. If nothing else, I know I'll need your input as this rolls along.

    Linda good luck with the clinical trial
    I hope you are able to meet your timeline to be in the clinical trial. And of course we want to hear about the process you will be going through. As you said it may be helpful for some of us in the future.

    You definitely have done your research, as usual, and are able to make an informed decision. Glad your onocologists are supporting your decision. Here's hoping you have minimal side effects and mush shrinkage of your lymph nodes. Wishing you the best. In peace and caring.
  • Ro10
    Ro10 Member Posts: 1,561
    unknown said:

    This comment has been removed by the Moderator

    Connie hope you continue to tell us about your IP/IV
    We certainly do not think you are "grandiose and full of yourself". We very much appreciate you keeping us up to date with your treatments and your progress. It is all new to us, and we appreciate the information you share. We may need to choose one of these options in the future. Hope you have had a good week and will have another one next week. In peace and caring.