January 18, 2013
Three weeks ago, I started this thread to update news on my progress in a clinical trial. Others have asked that this be made into a more general thread about clinical trials, hence the name change. Some of us are lucky enough to have oncologists who share, without prompting, information on clinical trials. Some of us actually have to go around our own doctors to find something else to try. It shouldn't be that way. To paraphase my own doctor: Without the clinical trials, all of today's drugs would not exist. How can new drugs be developed when it is so hard to get into a clinical trial? Oddly enough, he doesn't necessarily place the blame at the foot of the government as some might expect. He faults the difficulty is spreading information - to the patients as well as to the oncologists themselves.
Some patients, like myself, look for clinical trials when all other chemo has failed them. To me, the really brave ones are the ones who choose clinical trials instead of the already approved, proven drugs. Those patients are so important in the testing of a new drug, and so hard to come by.
If you have taken this uncharted fork in the road and have chosen a clinical trial, this thread is for you. If you're just considering one, join right in, too. No one here necessarily has answers, but we're looking hard, sharing connections that might help someone else. To all, please feel free to add thoughts and comments.
I started this phase 1 trial http://clinicaltrials.gov/ct2/show/NCT01633970
in August. I get an infusion of the study drug plus Avastin every 3 weeks. Today was round 7. I have a CT scan before every odd-numbered round. Today I got back the report from the 3rd scan since the baseline one. I am thrilled to report that I got good news for the third time.
On the scan before round 3, everything was stable. On the scan before round 5, some slight shrinkage was noted, one of the marker nodules was down about 15% by my calculations of the measurements. Today's report showed one of the marker nodules down 70% in size, and some others that appeared stable in size showed signs of cavitation.
Conclusion: "Stable, with slight improvement."
When I started this trial, I had 20-30 nodules scattered across my lungs. Only a few were larger than 1 cm, making changes difficult to note, unless they are signigicant. I cannot be called an official "responder" to the study unless I show 30% shrinkage when the total tumor burden is measured. With all these small nodules that might be difficult. Dr. P. tells me that patients with larger tumor burdens tend to show results earlier, so he is very pleased that I am showing any improvement at this point. I will celebrate big time if/when I am a "responder," but for now, I am very, very, thankful to be "Stable, with slight improvement."
This study is immune system therapy, attempting to get the patient's immune system to recognize the tumor as something it should fight. The side effects have been very minimal, just a general run-down feeling. Compared to my 5+ years with oxaliplatin and irinotecan, this really is no big deal.
The only downside to this trial is that it is offered in so few locations across the country, making it very difficult for most patients to consider it. If there is any hope with this drug, I want so badly to be able to share it with my friends. I feel guilty for feeling half-decent these days, especially when we have lost so many friends this past year, and right now, so many are out of options and losing hope.
There is another trial http://clinicaltrials.gov/ct2/show/NCT01375842
with this same study drug as a single agent. It is offered in a few more places across the country and in Europe, but still not exactly convenient to a lot of people. Dr. P. did say that the sponsor particularly wants CRC patients for this trial, but it will only be open a few more months. If anyone even thinks there might be some interest, he/she should contact one of the trial centers right away.
Today, I am very thankful for the time I have been given - time I certainly didn't expect. My daughter was 9 when I was diagnosed. She turned 16 this week.
I am also saying a prayer of thanksgiving for all my friends here, and praying for comfort for all those touched by this awful disease.