Clinical Trials: any reason to NOT do one? (Phase 2 trial of XL147)

lindaprocopio
lindaprocopio Member Posts: 1,980
edited March 2014 in Ovarian Cancer #1
I know some of you have done Clinical Trials. I have until next Wednesday to decide if I want to participate in one at Fox Chase in Philadelphia. ( http://clinicaltrials.gov/ct2/show/NCT01013324 ) I have a high grade recurrent endometrial cancer which is treated with the same drugs as ovarian cancer, but I think the drugs are typically much less effective. (For example, the gyne-onc at Fox Chase said that for my type of cancer, Doxil is only effective about 1/3 of the time at reducing tumor size, and the same with Gemzar.) That's why those of us with this aggressive cancer also have so much adjuvent pelvic radiation after our 6 rounds of carbo-taxol: if endometrial cancer comes back, the prognosis and statistical Overall Survival time is bleak, so you have to do everything you can to keep it from recurring. Unfortunately mine recurred pretty quickly.

Soooo, knowing that there is almost nothing beyond taxol (which I've taken until it no longer works for me) that really has a good chance of knocking me into remission since my 2nd recurrence, I am very tempted to participate in the trial and maybe be one of the 1st to take something that really works. It will involve a lot of travel (5 hours round trip twice a month) but the chemo is in pill form and with minimal side effects in Phase 1 of the Trial. (some rashes & diahrea; & I'd even have HAIR again!)

You can always drop out of the trial if your CA125 keeps climbing, right? I am currently symptom-free (other than being bald) but with active cancer in 2 growing lymph nodes. For those of you have considered a Clinical Trial, what did you factor into your decisions?

Comments

  • Lisa13Q
    Lisa13Q Member Posts: 677
    #2
    Clinical Trials
    Dear Linda,

    I have not been in a trial, but if you have read my posts you are aware that my mother is in one. Libby is also in the same trial as well. I also read up on yours a little and the drug they will be using. Here are my thoughts for what they are worth. Our family was aware that my mother's recurrance was fast and furious, and if we did nothing she could not survive for much longer so chemo was a must. She/you can get traditional chemo any time since they are approved by the FDA. Every chemo out there for recurrance had some lousy side effects and our gyn/onc said that truly they most likely would at best just hold the disease at bay. If she entered the trial, there was a possibility she could try some new inhibitor drug that could truly kill the cancer...there was no question in our mind she should do it. If she was placed in the control arm (which only received doxil) she was also told that she could get the PARP if the doxil did not work. She would never get that opportunity if she didnt join the trial. IN your case, there is no control and you just get the drug immediately, that is a huge bonus.

    Now, when in a trial she has had to be examined every week which involves at least an hour drive each way into New York City (depending in traffic). Yours would only be every other week. My sister likes that because Mom is now watched very closely and we don't have to be responsible for knowing if she needs hospitalization or blood transfusion etc. Also, she gets a CT scan every 2 months vs 3 months, which we really appreciate, since her cancer is so aggressive. You might like that as well. The do keep a tremendous eye on their subjects. Overall, the only downside to being in a trial is the constant doctors appointments, a small price for possibly having access to a drug that could save your life. The final reason I think you should do it is for the women who follow you....these drugs are the future. You are making a huge contribution to the treatment of this disease. IN fact, I hope Nancy 591 reads this as it might be a likely trial for her as well. Keep us posted.

    You can drop out any time....there is absolutely no downside to entering....
  • kayandok
    kayandok Member Posts: 1,202 Member
    #3
    I have looked into several trials
    but was always disqualified because of not living in the US. The trials in Japan also exclude me because I am not Japanese. I think clinical trials are wonderful, and as long as all your doctors agree, I would go for it. Meanwhile, if something else comes up that seems like a better treatment for you, you have the option of dropping out, right? You can't loose.
    kathleen
  • nancy591
    nancy591 Member Posts: 1,027 Member
    #4
    trials
    Yes, I am reading with great interest! Lisa, thank you for thinking of me!!!! I truly appreciate it. I was going to partake in a trial as well but when the Gemzar showed to be holding the cancer at bay it was recommended I continue on the Gemzar. Was I a bit disappointed?....maybe. Of course I was pleased the cancer was stable but nothing had shrunk. I am hopeful I will find something to knock it out. Had I known about the Doxil/parp trial prior to starting Doxil I would have signed up for that trial. The Doxil proved uneffective for me now I cannot get into that trial. Poor communication on my oncologist part which I am a bit ticked about. Now I make it my business to search the trials at my cancer center on a regular basis.

    For me to partake in a trial it would be about 5hrs round trip as well. Maybe a bit longer if the traffic is bad. Now, I travel about 4hrs round trip for standard chemo at one of Memorial Sloan's outpatient center.

    I agree with everything Lisa said. I would have participated because you can easily be excluded if you too many prior regimens. You can have standard chemo at anytime. The trial I was considering was an oral medication also. It is EMND-2076. The bad side is, like Lisa said, all of the appointments. It would be hectic, especially with the long drive. Plus, I have young kids to contend with as well. But I would have done it. A month before my next scan I will scour MSKCC website to see what trials are open. Going into my next scan I like to have a 'plan B' already in place.

    Good luck, Linda!!!!!!
  • Lisa13Q
    Lisa13Q Member Posts: 677
    #5
    nancy591 said:

    trials
    Yes, I am reading with great interest! Lisa, thank you for thinking of me!!!! I truly appreciate it. I was going to partake in a trial as well but when the Gemzar showed to be holding the cancer at bay it was recommended I continue on the Gemzar. Was I a bit disappointed?....maybe. Of course I was pleased the cancer was stable but nothing had shrunk. I am hopeful I will find something to knock it out. Had I known about the Doxil/parp trial prior to starting Doxil I would have signed up for that trial. The Doxil proved uneffective for me now I cannot get into that trial. Poor communication on my oncologist part which I am a bit ticked about. Now I make it my business to search the trials at my cancer center on a regular basis.

    For me to partake in a trial it would be about 5hrs round trip as well. Maybe a bit longer if the traffic is bad. Now, I travel about 4hrs round trip for standard chemo at one of Memorial Sloan's outpatient center.

    I agree with everything Lisa said. I would have participated because you can easily be excluded if you too many prior regimens. You can have standard chemo at anytime. The trial I was considering was an oral medication also. It is EMND-2076. The bad side is, like Lisa said, all of the appointments. It would be hectic, especially with the long drive. Plus, I have young kids to contend with as well. But I would have done it. A month before my next scan I will scour MSKCC website to see what trials are open. Going into my next scan I like to have a 'plan B' already in place.

    Good luck, Linda!!!!!!

    To Nancy
    I am glad the gemzar is holding the beast at bay.....you still may want to look into Linda's trial as it is open until end of next year. They are continuing to take people. It could well be your plan B. NO harm in looking and asking your doctor about it.
  • nancy591
    nancy591 Member Posts: 1,027 Member
    #6
    Lisa13Q said:

    To Nancy
    I am glad the gemzar is holding the beast at bay.....you still may want to look into Linda's trial as it is open until end of next year. They are continuing to take people. It could well be your plan B. NO harm in looking and asking your doctor about it.

    thanks
    Linda's trial is for endometrial cancer. Also, a trial can fill before the close date! The trial I was looking at was only taking 60 people nationwide. MSKCC has 20 of the 60 spots. My next scan is in 3 months. I'll be looking before hand.
  • lindaprocopio
    lindaprocopio Member Posts: 1,980
    #7
    nancy591 said:

    thanks
    Linda's trial is for endometrial cancer. Also, a trial can fill before the close date! The trial I was looking at was only taking 60 people nationwide. MSKCC has 20 of the 60 spots. My next scan is in 3 months. I'll be looking before hand.

    Turns out I'm OUT of the Clinical Trial after all. :(
    I got my call from Fox Chase and it looks like I'm OUT of the trial! I am disappointed, but I'm trying to be fatalistic about this. If I was able to participate in the Clinical Trial, I felt it was meant to be. Now that I can't, I am trying to feel the same way. I'm still bummed because I wanted to be a part of something brand-new and cutting edge.

    Here's what happened:
    It turns out that Fox Chase called my insurance to pre-certify all medical contingencies during my participation, and my insurance flat out said I would not be covered during the time I was participating in the Clinical Trial. They wouldn't cover my $22,000 "every-2-months" CT/PET scans or cover any medications or hospitalizations for problems I may run into taking this untested drug. So, although the DRUG is "free" to those on the trial, I would be on my own for any complications from it. I just can't take that chance or the chance that the insurance will blame the Trial for other problems I have down the road and refuse to cover them. My insurance paid out $330,000 last year for my treatment; I can't take a chance of NOT being covered.

    I'm glad I got the MUGA scan last week so that I can get right into Doxil chemo (locally) hopefully by early next week. & I'm glad that I met with my radiation oncologist and know that radiation will be my next option if the Doxil doesn't work. So at least I have a treatment PLAN in place, and that gives me some comfort. :(
  • nancy591
    nancy591 Member Posts: 1,027 Member
    #8
    lindaprocopio said:

    Turns out I'm OUT of the Clinical Trial after all. :(
    I got my call from Fox Chase and it looks like I'm OUT of the trial! I am disappointed, but I'm trying to be fatalistic about this. If I was able to participate in the Clinical Trial, I felt it was meant to be. Now that I can't, I am trying to feel the same way. I'm still bummed because I wanted to be a part of something brand-new and cutting edge.

    Here's what happened:
    It turns out that Fox Chase called my insurance to pre-certify all medical contingencies during my participation, and my insurance flat out said I would not be covered during the time I was participating in the Clinical Trial. They wouldn't cover my $22,000 "every-2-months" CT/PET scans or cover any medications or hospitalizations for problems I may run into taking this untested drug. So, although the DRUG is "free" to those on the trial, I would be on my own for any complications from it. I just can't take that chance or the chance that the insurance will blame the Trial for other problems I have down the road and refuse to cover them. My insurance paid out $330,000 last year for my treatment; I can't take a chance of NOT being covered.

    I'm glad I got the MUGA scan last week so that I can get right into Doxil chemo (locally) hopefully by early next week. & I'm glad that I met with my radiation oncologist and know that radiation will be my next option if the Doxil doesn't work. So at least I have a treatment PLAN in place, and that gives me some comfort. :(

    BUMMER
    I imagine it is sooooo disapointing not being able to participate due to insurance. What a BUMMER!!! Yes, having a plan in place is comforting!
  • lindaprocopio
    lindaprocopio Member Posts: 1,980
    #9
    nancy591 said:

    BUMMER
    I imagine it is sooooo disapointing not being able to participate due to insurance. What a BUMMER!!! Yes, having a plan in place is comforting!

    There aren't THAT many options; hate to lose one.
    According to the new national healthcare reform, in 2014 all insurance companies will be forced to cover associated medical care of those with life-threatening disease choosing to do Clinical Trials. Unfortunately 2014 is too late for me, most likely. Maybe not. I'll make some last-ditch calls this morning, but I expect to start Doxil next week, my "Plan B". Thanks, Nancy, for the commiseration.
  • kayandok
    kayandok Member Posts: 1,202 Member
    #10
    lindaprocopio said:

    There aren't THAT many options; hate to lose one.
    According to the new national healthcare reform, in 2014 all insurance companies will be forced to cover associated medical care of those with life-threatening disease choosing to do Clinical Trials. Unfortunately 2014 is too late for me, most likely. Maybe not. I'll make some last-ditch calls this morning, but I expect to start Doxil next week, my "Plan B". Thanks, Nancy, for the commiseration.

    I'm so sorry!
    I just read this post after I asked you about the trial on the Doxil post. Super bummed for you. I do have to admire the way you are able to change your perspective so quickly. Linda, you inspire me ❤

    kathleen

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