Evero;imus clinical trial
Comments
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Everolimus trial
Have you had a good appraisal of what's in it for you? It sounds as if your prognosis is so good that you're on a hiding to nothing going in for it. If no-one has given you a well-reasoned justification for being a guinea pig I think you should demand such a justification and unless it's very compelling, turn down the offer of the trial.
It's very worthy to help in the advance of knowledge but there's a limit to what makes sense in the cause of altruism and charity begins at home. If i were in your shoes I'd turn it down flat unless and until I were given a totally convincing argument for participating.0 -
Everolimus TrialTexas_wedge said:Everolimus trial
Have you had a good appraisal of what's in it for you? It sounds as if your prognosis is so good that you're on a hiding to nothing going in for it. If no-one has given you a well-reasoned justification for being a guinea pig I think you should demand such a justification and unless it's very compelling, turn down the offer of the trial.
It's very worthy to help in the advance of knowledge but there's a limit to what makes sense in the cause of altruism and charity begins at home. If i were in your shoes I'd turn it down flat unless and until I were given a totally convincing argument for participating.
I know exactly what you are going through. I am stage 1, grade 4 (5% sarcomatoid) clear cell and I was presented this same scenario at my first office visit in January. Just when you think things are okay they throw this at you! My oncologist made the appointment for me (I didn't know about it until I showed up for my appointment with him) and I went to the appointment with the other doctor out of respect/politeness..
I looked at everything and turned them down. They were so eager to get someone in the trial (with a placebo) until I felt like they were just looking for a guinea pig like TW said.
This is all fresh in my mind because I just got a bill for $400+ for the office visit where they promoted the trial to me. I was shocked that I was charged and I'm fighting that bill.
--David0 -
BillDMike said:Everolimus Trial
I know exactly what you are going through. I am stage 1, grade 4 (5% sarcomatoid) clear cell and I was presented this same scenario at my first office visit in January. Just when you think things are okay they throw this at you! My oncologist made the appointment for me (I didn't know about it until I showed up for my appointment with him) and I went to the appointment with the other doctor out of respect/politeness..
I looked at everything and turned them down. They were so eager to get someone in the trial (with a placebo) until I felt like they were just looking for a guinea pig like TW said.
This is all fresh in my mind because I just got a bill for $400+ for the office visit where they promoted the trial to me. I was shocked that I was charged and I'm fighting that bill.
--David
I'd be shocked too, David and I'd be furious - I hope you're successful in contesting that bill.
My tumours were mostly sarcomatoid so no surprise to be grade 4 but I'm a little surprised that you were too. Was this on the basis of being 5% sarcomatoid, or were there other factors?0 -
BillDMike said:Everolimus Trial
I know exactly what you are going through. I am stage 1, grade 4 (5% sarcomatoid) clear cell and I was presented this same scenario at my first office visit in January. Just when you think things are okay they throw this at you! My oncologist made the appointment for me (I didn't know about it until I showed up for my appointment with him) and I went to the appointment with the other doctor out of respect/politeness..
I looked at everything and turned them down. They were so eager to get someone in the trial (with a placebo) until I felt like they were just looking for a guinea pig like TW said.
This is all fresh in my mind because I just got a bill for $400+ for the office visit where they promoted the trial to me. I was shocked that I was charged and I'm fighting that bill.
--David
I'd be shocked too, David and I'd be furious - I hope you're successful in contesting that bill.
My tumours were mostly sarcomatoid (chromophobe) so no surprise to be grade 4 but I'm a little surprised that you were too. Was this on the basis of being 5% sarcomatoid, or were there other factors?0 -
Grade 4Texas_wedge said:Bill
I'd be shocked too, David and I'd be furious - I hope you're successful in contesting that bill.
My tumours were mostly sarcomatoid (chromophobe) so no surprise to be grade 4 but I'm a little surprised that you were too. Was this on the basis of being 5% sarcomatoid, or were there other factors?
The pathologist's comments for my 5cm tumor with 5% sarcomatoid:
"The tumor is predominantly clear cell with a Fuhrman nuclear grade 3/4. However there is a focal area with tumor cells exhibiting rhabdoid features in a myxochondroid background, thus warrant a Fuhrman nuclear grade 4/4. This case was reviewed in the Consultant's Conference on 12/9/11, with consensus as to the diagnosis."
So, I'm not really sure if it's a grade 3 or 4. I did not have this report when I met with him after surgery. I'm much more prepared to ask questions at my next appointment and first followup scan in June.
--David0 -
Clinical TrialDMike said:Grade 4
The pathologist's comments for my 5cm tumor with 5% sarcomatoid:
"The tumor is predominantly clear cell with a Fuhrman nuclear grade 3/4. However there is a focal area with tumor cells exhibiting rhabdoid features in a myxochondroid background, thus warrant a Fuhrman nuclear grade 4/4. This case was reviewed in the Consultant's Conference on 12/9/11, with consensus as to the diagnosis."
So, I'm not really sure if it's a grade 3 or 4. I did not have this report when I met with him after surgery. I'm much more prepared to ask questions at my next appointment and first followup scan in June.
--David
Sunlover_56,
Based upon your pathology I agree with Tex and his reasoning.
Icemantoo0 -
Thanks everyone. I prettyicemantoo said:Clinical Trial
Sunlover_56,
Based upon your pathology I agree with Tex and his reasoning.
Icemantoo
Thanks everyone. I pretty much decided not to take it.. I am thinking if the cancer should come back (20% to 30% chance) then I will deal with it then. I need to start thinking on the lines that I am cancer free. If I do this trial it will be another year of having to deal with and think about my cancer and treatments. I am going by the old phrase. Ifs its not broke dont fix it.. lol by the way. If it would change any of you're advice to me, it actually was approved by the FDA, bu for advanced RCC.. they now want to see what it does for patience who have not had any reaccurances to see if it will stop them.0 -
To DMikesunlover_56 said:Thanks everyone. I pretty
Thanks everyone. I pretty much decided not to take it.. I am thinking if the cancer should come back (20% to 30% chance) then I will deal with it then. I need to start thinking on the lines that I am cancer free. If I do this trial it will be another year of having to deal with and think about my cancer and treatments. I am going by the old phrase. Ifs its not broke dont fix it.. lol by the way. If it would change any of you're advice to me, it actually was approved by the FDA, bu for advanced RCC.. they now want to see what it does for patience who have not had any reaccurances to see if it will stop them.
Was the drug they were promoting Everolimus?0 -
Everolimussunlover_56 said:To DMike
Was the drug they were promoting Everolimus?
sunlover_56,
Yes, they were promoting an Everolimus trial. I checked the paperwork and the trial title is "S0931 - EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study". It's sponsored by the National Cancer Institute and Southwest Oncology Group.
I just didn't see any point in participating.
--David0 -
DMikeDMike said:Everolimus
sunlover_56,
Yes, they were promoting an Everolimus trial. I checked the paperwork and the trial title is "S0931 - EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study". It's sponsored by the National Cancer Institute and Southwest Oncology Group.
I just didn't see any point in participating.
--David
That is exactly the same trial offered to me.. I have decided not to participate either. To many side effects and not enough proof it will do me any good. Hope I am doing the right thing. I am usually a pretty strong minded person but this DX has me like a noodle brain. lol. I AM coming back though.0 -
Trial...sunlover_56 said:DMike
That is exactly the same trial offered to me.. I have decided not to participate either. To many side effects and not enough proof it will do me any good. Hope I am doing the right thing. I am usually a pretty strong minded person but this DX has me like a noodle brain. lol. I AM coming back though.
Sunlover & David,
For what its worth I think you made the right decision. I don't understand how a trial to prevent recurrence proves anything unless the test group has very high odds of recurrence in the first place, something just seems off to me.0 -
trialgarym said:Trial...
Sunlover & David,
For what its worth I think you made the right decision. I don't understand how a trial to prevent recurrence proves anything unless the test group has very high odds of recurrence in the first place, something just seems off to me.
My thoughts exactly. And also my response last May when they wanted me to trial votrient. I've been realy glad I made my decision. Good luck to you too.0 -
trialfoxhd said:trial
My thoughts exactly. And also my response last May when they wanted me to trial votrient. I've been realy glad I made my decision. Good luck to you too.
Thank you Fox, Gary, Tex, Ice, and Mike.. and everyone.. I am feeling better and better now about my decision after hearing from you all. I think I will fire up my BBQ and cook some steak.. Its time I try to forget about cancer for a while and start to enjoy all the things I love to do!!0 -
profilesunlover_56 said:trial
Thank you Fox, Gary, Tex, Ice, and Mike.. and everyone.. I am feeling better and better now about my decision after hearing from you all. I think I will fire up my BBQ and cook some steak.. Its time I try to forget about cancer for a while and start to enjoy all the things I love to do!!
I just learned how to do my profile.. lol.. now I need to figure out how to add all of you wonderful people to my friends list :-)0 -
trial-checking insunlover_56 said:profile
I just learned how to do my profile.. lol.. now I need to figure out how to add all of you wonderful people to my friends list :-)
Hi all,
Been awhile since l have posted although I do drop in to check on everybody. I have been really busy with work and with the weather being nice, spending a lot of time outdoors. I just started my second cycle on the Everest trial. Other than a little insomnia, I haven't experienced side effects. It is quite possible I am getting the placebo but my research nurse tells me most are tolerating it well. I take 2 pills every morning so nothing to it. I get a physical and blood work every 6 weeks and ct scans at 18 weeks. I am not sure if this trial will benefit me in anyway but if the research from this can help someone in the future, it will be worth me being a guinea pig. At the very least, I am being monitored closely which does comfort me somewhat.
Health and happiness to all,
Wayne0 -
Everest trialcww71964 said:trial-checking in
Hi all,
Been awhile since l have posted although I do drop in to check on everybody. I have been really busy with work and with the weather being nice, spending a lot of time outdoors. I just started my second cycle on the Everest trial. Other than a little insomnia, I haven't experienced side effects. It is quite possible I am getting the placebo but my research nurse tells me most are tolerating it well. I take 2 pills every morning so nothing to it. I get a physical and blood work every 6 weeks and ct scans at 18 weeks. I am not sure if this trial will benefit me in anyway but if the research from this can help someone in the future, it will be worth me being a guinea pig. At the very least, I am being monitored closely which does comfort me somewhat.
Health and happiness to all,
Wayne
Good to see Wayne back, even just as an occasional visitor - it's cheering to see people have good outcomes and go off and get on with their lives, just as it's good to see others with good stories who can find the time to stick around, like iceman and GaryM to help the endless stream of newcomers.
I feel the need to comment now because I nailed my colours to the mast here, against the trial (for sunlover) but had supported Wayne in going for it a couple of months ago. This is not inconsistent. The two cases are different and it's always a matter of 'horses for courses' with RCC. Wayne is young, very fit and psychologically robust, so well able to endure the possible side-effects (and you'll see he hasn't been bothered by them, assuming he's not on the placebo!) The key fact is that his prognosis is a little poorer than sunlover's, being stage 3 with some renal vein invasion. Consequently, he has a higher risk of recurrence and so being in the trial is better indicated in his case.
Aside from this, Wayne made a very compelling argument for it in his situation (on the "Need advice" thread started by Raj)
"It is a blind trial as well, but the way I see it is that whether or not I get the drug, I have established a relationship with an oncologist, and I am going to be closely monitored. If it does come back, it will be caught early. In Gerald White's book he says that " if you don't take charge of your own healthcare somebody else will and you won't like the results". I am doing everything in my power to increase my chances of staying cancer free. Exercise, dietary changes and most of all, a positive attitude."
I think that was excellent reasoning on Wayne's part. For sunlover, I feel she has the exercise, diet and attitude angles well covered and also has youth and tough-mindedness on her side but doesn't have the reasons Wayne had for entering the trial.
So, I believe both arrived at the best decisions for themselves and both have also benefited from being very active participants in managing their own health.0 -
TrialTexas_wedge said:Everest trial
Good to see Wayne back, even just as an occasional visitor - it's cheering to see people have good outcomes and go off and get on with their lives, just as it's good to see others with good stories who can find the time to stick around, like iceman and GaryM to help the endless stream of newcomers.
I feel the need to comment now because I nailed my colours to the mast here, against the trial (for sunlover) but had supported Wayne in going for it a couple of months ago. This is not inconsistent. The two cases are different and it's always a matter of 'horses for courses' with RCC. Wayne is young, very fit and psychologically robust, so well able to endure the possible side-effects (and you'll see he hasn't been bothered by them, assuming he's not on the placebo!) The key fact is that his prognosis is a little poorer than sunlover's, being stage 3 with some renal vein invasion. Consequently, he has a higher risk of recurrence and so being in the trial is better indicated in his case.
Aside from this, Wayne made a very compelling argument for it in his situation (on the "Need advice" thread started by Raj)
"It is a blind trial as well, but the way I see it is that whether or not I get the drug, I have established a relationship with an oncologist, and I am going to be closely monitored. If it does come back, it will be caught early. In Gerald White's book he says that " if you don't take charge of your own healthcare somebody else will and you won't like the results". I am doing everything in my power to increase my chances of staying cancer free. Exercise, dietary changes and most of all, a positive attitude."
I think that was excellent reasoning on Wayne's part. For sunlover, I feel she has the exercise, diet and attitude angles well covered and also has youth and tough-mindedness on her side but doesn't have the reasons Wayne had for entering the trial.
So, I believe both arrived at the best decisions for themselves and both have also benefited from being very active participants in managing their own health.
Arent you being monitored more closely due to the side effect? If you're not on it then you dont need to worry about side effect.. I will still get a scan to see if the cancer comes back the same amount of times as if I was on the trial. I would love to do the trial to help the next person who gets RCC, but for me, my emotional state is very important to my healing and if I was on this pill for the next year, I would be worried about every little pain or ache or cough.. etc...Also about the fact that it can increase your risk of getting a different type of cancer. (I read that if you accidentally crushed it or broke it open in your hand, you need to wash your hands asap.. now that scares me to put something like that in my body.. I am trying to keep positve and stop thinking about the big "C" word. I am concidering myself cancer free since they told me they got it all (That may be foolish cause I know it can come back) but I have to believe it wont. Should it come back in the future, I will deal with it then. If I was on this trial for the next year or several years it will keep cancer in the forfront of my life when I dont want it there anymore. Perhaps my reasoning is a little bit of hopeful thinking but thats how I feel. I do, though, respect anyone eles's choice to participate in this trial.0 -
Trialsunlover_56 said:Trial
Arent you being monitored more closely due to the side effect? If you're not on it then you dont need to worry about side effect.. I will still get a scan to see if the cancer comes back the same amount of times as if I was on the trial. I would love to do the trial to help the next person who gets RCC, but for me, my emotional state is very important to my healing and if I was on this pill for the next year, I would be worried about every little pain or ache or cough.. etc...Also about the fact that it can increase your risk of getting a different type of cancer. (I read that if you accidentally crushed it or broke it open in your hand, you need to wash your hands asap.. now that scares me to put something like that in my body.. I am trying to keep positve and stop thinking about the big "C" word. I am concidering myself cancer free since they told me they got it all (That may be foolish cause I know it can come back) but I have to believe it wont. Should it come back in the future, I will deal with it then. If I was on this trial for the next year or several years it will keep cancer in the forfront of my life when I dont want it there anymore. Perhaps my reasoning is a little bit of hopeful thinking but thats how I feel. I do, though, respect anyone eles's choice to participate in this trial.
Sunlover,
I completely understand your reasoning as well. I must say however, that in all the paperwork, disclosures, possible side effects, etc. I did not see anything about the possibility of the drug causing any other cancers. Believe me, I read through all the paperwork numerous times and there was nothing of the sort. Also,the pills are small and hard, not capsules, so you would have to intentionally crush them but again there was nothing in the documentation discussing that either. Not that any of that should sway your decision. As Tex wrote, you and I were in different situations, different percentage chances for recurrence. I didn't want to be in a position down the road where I asked myself why didn't I go on the trial.
Health and happiness to all,
Wayne0 -
CWW (wayne )cww71964 said:Trial
Sunlover,
I completely understand your reasoning as well. I must say however, that in all the paperwork, disclosures, possible side effects, etc. I did not see anything about the possibility of the drug causing any other cancers. Believe me, I read through all the paperwork numerous times and there was nothing of the sort. Also,the pills are small and hard, not capsules, so you would have to intentionally crush them but again there was nothing in the documentation discussing that either. Not that any of that should sway your decision. As Tex wrote, you and I were in different situations, different percentage chances for recurrence. I didn't want to be in a position down the road where I asked myself why didn't I go on the trial.
Health and happiness to all,
Wayne
The articles that I read said that if the pill was crushed or boken for some reason and you got it on your hands you ahould wash right away. I have the link to that. I also have a link from Drug.com stating that it increases your risk for lymphoma and skin cancers.I I know you didnt mean to but your post upset me just a little. I was quite convinced I had made the right decision. I think your last statement is what worried me a little... Quote: "I didn't want to be in a position down the road where I asked myself why didn't I go on the trial."
Here is one of the links where I found info
http://www.drugs.com/cons/everolimus.html
If you scroll down to "Proper use of Everolimus" you will read about the crushed or broken pill.
Even if I have some misinformation, I still dont feel 100% comfortable taking this drug.. it mentions Hepititis B also can flare back up if you have had it before and I did when I was a small child. I hope and pray that I am making the right decision.0 -
Everolimus trialsunlover_56 said:CWW (wayne )
The articles that I read said that if the pill was crushed or boken for some reason and you got it on your hands you ahould wash right away. I have the link to that. I also have a link from Drug.com stating that it increases your risk for lymphoma and skin cancers.I I know you didnt mean to but your post upset me just a little. I was quite convinced I had made the right decision. I think your last statement is what worried me a little... Quote: "I didn't want to be in a position down the road where I asked myself why didn't I go on the trial."
Here is one of the links where I found info
http://www.drugs.com/cons/everolimus.html
If you scroll down to "Proper use of Everolimus" you will read about the crushed or broken pill.
Even if I have some misinformation, I still dont feel 100% comfortable taking this drug.. it mentions Hepititis B also can flare back up if you have had it before and I did when I was a small child. I hope and pray that I am making the right decision.
I think what you were remembering, sunlover, was on MedlinePlus, under the ominous heading "Important Notice"
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a609032.html#special-dietary
There's no doubt it's powerful stuff and I've read elsewhere about washing it off your skin in the event of exposure as a result of a broken or crushed tablet or in laboratories etc. or if involved in fire-fighting when there might be a risk of inhalation etc.
On a hobby horse of mine about interactions, I note the warning not to have grapefruit or grapefruit juice, or St. John's Wort, if on everolimus.
I'm still convinced that you made the right decision and also that Wayne's analysis was sensible on the data he had available.
I'm just a little disquieted that some aspects evidently weren't made clear to him and wonder whether the information supplied was edited down. Usually the accompanying warnings with medications err on the side of alarmism (doubtless due to the advice of my brethren in the legal profession) but maybe it's different with powerful toxic agents that someone wants you not to be put off taking!
Fortunately Wayne is doing fine and I must confess that if I were in his shoes I wouldn't mind if I found I'd been on the placebo! He will have the satisfaction, whether on the drug or the placebo, of knowing he's helped further research and he's getting the expert close monitoring he wanted with the guarantee of an early alert if it becomes appropriate, which we all hope it won't.0
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