When I was initially diagnosed with stage 4 colorectal cancer, my oncologist recommended that I take part in a clinical trial that he was running. It was a phase 2 trial comparing the effectiveness of a new drug Tivozanib versus Avastin. He had a great sales pitch and his main arguments were:
1. IF I received Tivozanib in the trial, this would leave Avastin in reserve to use later. This was a very good thing, he said, as It would leave another option on the table once Tivozanib stopped working.
2. In the phase one trial, Tivozanib was shown to be safer, with less side effects than Avastin. The most important however, was a 2 month increase in PFS (Progression Free Survival).
3. I would receive a much better standard of care with additional tests, a dedicated trial nurse to look after me etc.
As this was my first meeting with the oncologist, I had little experience in these things and was inclined to trust his judgement. So I quite happily signed up to take part in the trial. For my oncologist this must have been christmas come early, as I was the ideal candidate for the trial and I would have been the first at the hospital. (He did not mention this, but I found this out later from the trial nurse).
Once I got home, I began to research Tivozanib in more detail and that is when doubt started to set in. There was very little information available and the phase 1 study did indeed look promising, but when I looked at the manufacturer of the drug, I discovered that they had financial trouble, and fired around 150, mostly research staff. You don’t do that unless you are in some serious trouble. So I dug deeper.
The problem with Tivozanib turned out to be a phase 3 trial for Renal Cancer. Preliminary results reported to the FDA showed a decrease in OS (Overall Survival) even with better PFS results. The manufacturer argued that these were preliminary results as not enough people had died yet. Still it was enough to put the FDA approval of Tivozanib in doubt and this was the cause of the financial troubles as investors pulled out. Oddly when a I mentioned all of this to my oncologist he knew nothing of this, nor of the renal cancer trial results.
So here I was about to take part in a dose escalation trial for a drug that would at most give me 2 months better PFS, but could shorten my life in the process. There was no upside here.
I than realised something else. While I was on Tivozanib, my oncologist would want to keep me JUST on Folfox + Tivozanib until the disease progressed. He would not offer any other treatment as that would make me illegible for the trial and he would discourage me from seeking anything else. As it turned out, Folfox just produced a stable disease for me after 5 cycles. My new oncologist put me onto Folfiri instead. Had I been on the trial I would have been left in Folfox till the disease progressed.
After doing more research, I realised that the argument of using Tivozanib first and leaving Avastin in reserve did not stand up either. Both drugs target the VEGF receptor. Once my little mutants mutate further and learn how to bypass VEGF to sustain angiogenesis, both Tivozanib and Avastin would stop being effective.
The better care argument was spot on. I had lots of extra care while on the trial, extra tests and a personal nurse tracking my health and progress. That was nice, but not likely to make any difference in the long run.
I also sought a second, third, fourth and even fifth opinion. I talked to an oncologist at the same hospital, and three others to get their opinion about the trial. 3 out of 4 oncologists I have spoken to advised against the trial. One was neutral. They said that from their experience most clinical trials are detrimental to the patients involved and would not recommend them, especially phase 1 & 2 trials.
When I informed my oncologist that I was pulling out if the trial he was not happy. I could see it in his face. But he did say that I could pull out any time. What upset me the most however, is the hospital invoiced me for all the extra CT scans they did for the trial which were supposed to have been covered by the trial sponsor. That was low I though, especially as this was a private hospital and I had no insurance to cover any treatments done there.
In summary, from the feedback I received from various oncologists, the consensus seems to be that most trials are detrimental to patients and oncologists are likely to withhold other possible treatments while on the trial. You also risk being a guinea pig for the testing of new treatments and many people have died from trials, especially those in phase 1. Still, if you are out of options and time, some trials can be worth the risks. I would however assess the possible benefits very carefully. A trial of a new drug which at best will give you 2 months PFS like in my case, I would not go into.
Tip: When joining a trial, don’t forget to ask about the relationship the oncologist has with the trial sponsor. Many trials will actually pay the oncologist a substantial amount for every patient they sign up. If your oncologist receives financial gain from your trial participation, be extra careful and always get a second opinion.
I timed my GCMAF injections to avoid the worst of the chemo cytotoxic effects and today was the day. Let me just say that I hate needles. I get sick when ever I have to get my blood taken, and I have been known to faint if they have troubles finding a vein. I know its all psychological, but no idea how to overcome it. The port has been great and for some reason I have absolutely no problem with this. No problems with the needle going in, and I can watch the blood being taken with no reaction what so ever. Go figure.
