Trials. This, as I understand it, is how they generally work: A research group wants to test a new drug or combination of drugs on RCC warriors. Warriors have to pass certain physical well-being tests to qualify, not only to see if they can take the new drug or combination, but also go X amount of time without any therapy, the so-called placebo group. Placebo: Nothing, nada, not a thing, pure water, etc. The new drug or mixture of drugs: Maybe, might, could, perhaps help your cancer. More likely not to maybe, might, could, perhaps help your cancer. Either way it is a crap shoot. And for the research team, actually helping cure anything is not necessarily their job, instead they are looking for ways their regimen might affect cancers, the organs cancer has attacked or the body's general reaction to the drug, not necessarily eliminate or stabilize tumors. Or that is how I understand it.
Please, dear reader, correct me if I am wrong.
On the ACOR List trials are a very hot topic. Many warriors, often those brand new to the disease, seem frantic to find one, to have the opportunity to get no medicine just so they might get an unproven one. (Isn't that why they are called "trials?") Even my dim brain can understand that if the warrior is close to terminal and if there seems to be no other alternative, a trial is as good anything else. Certainly may bring additional hope. But for those dealing in stabilizing or reducing tumors, who are in pretty good health and not facing imminent issues of decline, AND with such much evidence the "nib" treatments are doing a better than yoeman job, what is the attraction of a trial? Perhaps they want to help the science move forward? Ah, altruism! A wonderful motivation. Our researchers need all the help they can get. However, my reading indicates most of these folks are looking for a magic bullet. But most trials, I am told, don't cure anything....they just add to the literature, the body of research that might add up, one day, to a better therapy for cancer. And that is a wonderful object, but if you have cancer, might you not be more concerned with the realities of your own battle than with those of the future.
Please, dear reader, correct me if I am wrong.
Now, David Foster is perfectly happy with warriors getting any care they wish, from trials to "nibs" (Sutent and Nexavar are nibs) to chewing on cuttle fish. Heck, I've considered shooting my tumors (kidding). And to reiterate, I certainly have nothing against trials. They are more than important to research; without them we would not have the "nibs," or even a headcold medicine for that matter. But as for the warriors who are so concerned--almost obsessed--about getting into one, I just don't understand the gamble. We have drugs today that are proven to stabilize and even eradicate RCC mets. Some don't work on everybody and like I said, if there is no other alternative, a trial might be the best idea. But only some of those people are going to get the new drug. And the participating warriors don't know which ones. And even those haven't the slighest guarantee of greater help. If you have metastasized RCC, that seems a dangerous--and sometimes expensive--game to play. Many insurance carriers won't, I understand, play at all.
There must be something going on in all this--other than fear of some warriors--that anything proven (fewer than three years proven) doesn't have near the potential of something "cutting edge." I am just not getting it. One reason: In all my reading I have never seen a report that said, "I was in such and such a trial and they cured my cancer. NED." Maybe I just miss those. Or maybe they can't tell us. But I do know in most cases I am aware of, once the trial is done, it is back on Sutent or whatever. It is one thing to gamble with your money; a whole nother to gamble with your cancer, especially for no proven reason.
Please, dear reader, (and this is not a rhetorical question) correct me if I am wrong.
Just punch the comment or e-mail button and have at it.
Answers:
(Maria writes, see comments, that second and third phase trials are much more directed and often helpful, up to and including stablization, while phase one trials are pretty much as I described them. However, she speaks of proven drugs in those higher phase studies. Would that be something completely new or would it be more a combination if drugs like Avastin/Sutent or whatever?)
Dave,
I agree with you in part, and disagree in part. Your entry today seems to talk mostly about phase I trials. In those, the patient is truly the guinea pig. But there are phase II and III trials where the drug has been proven and docs are now trying to see results in a broader group. There are many folks on some of the RCC message boards (you post on some of those) who have been taking Sutent as part of a trial, and who report elimination or stabilization of those tumors for a few years so far.
My family member has chromophobe RCC with some limited mets (though any mets are too many) and was offered a phase I trial of torisel and a chemo drug. I was there when they sent the clinical nurse to try to sell her on it. There was no way she was going to do that when she has a good prognosis.
She did, however, seek out and agree to do a phase I/II trial of sutent with stereotactic radiation to her spine mets (just what they used on your brain). Why? (1) No one has ever studied the combination before though some data suggested combining the radiation with other drugs like nexavar was very helpful; (2) both treatments are proven and approved alone; (3) the docs thought it sounded like a good idea even though it was held at a different hospital; (4) given the location of her mets she would likely need radiation eventually anyway; and (5) (this is not a small point) the Sutent was FREE!
Now my family member is not poor, and is now on a good medicare plan, but she was still looking at a $3,500 copay for the first cycle, and several hundred for subsequent cycles, and that was just for this year alone.
As you noted in some of your prior entries, some are not so lucky, and to pay for these drugs is a major struggle. So a study offering free drugs is very attractive.
Great, thought-provoking entry today Dave!
Posted by: Maria | October 19, 2007 at 10:46 PM
Ha David. I like that you don't know squat about trials and Joe has never been on one. However at one point before sutent was approved they were going to send him on one (sutent got approved and the trial was stopped). I asked about the treatment and our oncologist said that one group would get some sort of drug and the other would get the new drug. I asked about the placebo and she said that was not true. She said that they have to treat you but they don't have to give you the new drug. So I, like you, say "correct me if I am wrong".
Posted by: Mary | October 19, 2007 at 06:59 PM