A Tale of a Trial

If there are demerit points for bloggers, I’ve surely earned quite a few by going through a clinical trial from entrance to exit without blogging about the experience at all. I will do my best to make up for this omission of potentially useful information with a synopsis of my experience.

If you have decided that a clinical trial might be your best next option, the first step is finding a clinical trial for which you match the profile of a qualified participant and that is at a logistically possible location. When my search for a clinical trial began in earnest in March 2015, I knew that there were two possible drugs that might be my best second line of treatment. One drug, AZD9291, had closed its trials and was moving towards FDA approval. The second drug, CO-1686, also called rociletinib, had an open trial at Roswell Park Cancer Institute in Buffalo, NY. I met the initial qualifications and I have family in Rochester, just an hour and a half from Roswell. So, game on!

How does a clinical trial start? With paperwork: the informed consent form. The trial I participated in was titled “A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)”, and the consent form was 26 pages long. I click right through online consent forms for software upgrades and the like, but I read every page of the consent form the night before the day when I would sign it, April 9, 2015.

For this trial, the next step after signing the consent form was a biopsy of my cancer to see if I had developed a T790M mutation during my first line of treatment. We biopsied a hot lymph node in my neck on April 27, 2015. Then I waited. And waited. And waited for results. It took about three weeks time, which were long weeks, as it was becoming pretty evident that my first line of treatment was failing. Finally the word came on May 15 that I was positive for T790M. 

I took my first dose of the experimental drug on June 11, 2015. This day began a new schedule that would take top priority in my husband’s and my lives for the next 8 months: travel to Roswell every 3 weeks, plus additional travel for CT scans. We could not have done this without support. A dear friend offered to housesit and take care of our pets, and he came to our home nearly every time we went to Roswell. My mother gave us a home away from home in Rochester, treating us to home cooked meals and relaxed evenings reading and watching the news. As an unexpected bonus, special cancer treatment coverage included in my health insurance paid all of my copays and reimbursed us for our travel expenses, because Roswell is a center of excellence in cancer treatment.

After the trial began, there was more paperwork. I was responsible for keeping a log of when I took each dose of my medication. I also logged daily tests of my blood sugar levels. These logs were turned in at each clinic visit, along with all pill bottles and any unused medication. On clinic days I filled out surveys and signed a few additional informed consent forms.

Side effects: there were quite a few, and at times my ability to adapt was put to the test. They included:
  • Hyperglycemia. This began within two weeks of beginning treatment, and for a while I experienced very high blood sugar readings, reaching into the 300’s and 400’s. I spent one night in the observation unit at a local hospital having my blood sugar levels reset with insulin, as the medications prescribed to control the hyperglycemia had not yet become effective. At first I was prescribed metformin and glimepiride, and they were not effective at making my blood sugars become stable. The metformin also made me feel terrible, with exhausting malaise and diarrhea. I cut way back on my intake of carbohydrates which helped with the blood sugar levels, but in combination with the metformin caused me to lose weight rapidly. My trial oncologist decided to work with my family doctor to get my hyperglycemia under control, and he put me on a different drug, Jardiance. This drug worked. My blood sugar levels stabilized, and so did my weight as my diet returned to normal. I also shed that pesky malaise.
  • Muscle cramps. At night time, my legs and feet would cramp painfully. I learned not to stretch in bed, and to walk the cramps away. This was annoying but tolerable.
  • Stuffed up ears. In August, I had an upper respiratory infection which resulted in swollen eustachian tubes that took months to unplug. This side effect probably was the most annoying one I experienced. I didn’t like not hearing clearly, and my husband surely got tired of me asking him to repeat nearly everything he said to me. I believe the slow healing from the infection was caused by lower than normal counts of both red and white blood cells.
  • QT interval prolongation. This is the side effect I could not control, and which resulted in the end of the trial for me. Long QT intervals in the heart rhythm are bad, potentially resulting in sudden death. Twice my QT interval went over the upper limit defined in the trial protocol, and as a result twice my dosage of the experimental medication  had to be reduced. My final reduction was in mid-December 2015, a week after CT scans showed my cancer to be stable. I was now taking half the dose that I was taking at the start of the trial. CT scans done 8 weeks after that dose reduction revealed that my cancer had started to grow again, both in the primary tumor and lymph nodes, plus I had a brand new pericardial effusion. The conclusion: I could no longer tolerate an effective dose of the medication. 
My listing of side effects above might sound discouraging. I need to add that I had many, many days when I felt good during this trial. Overall, I would rate quality of life as decent to good to great, depending on the day,  particularly considering the alternatives available to me during the time of the trial. I have absolutely no regrets, and a great deal of gratitude that this treatment was available to me.

Sayonara, clinical trial. Patients say they are kicked off of or booted from a trial, and that’s what it feels like. I didn’t expect the trial to end for me when I went to Roswell on February 18. I had to make a decision as to my next step right then and there, and that was nerve wracking. Chin up, though. I got through the day, and I have not shed a tear. I would sign up for another clinical trial in a heartbeat.

Fortunately there is a good option for my third line of treatment - that drug that had closed its trials back in March 2015. It is now FDA approved, newly named as Tagrisso, and available by prescription. I started taking it just under a week ago, and already I feel better. This is a good alternative because we think the growth of the cancer was due to me not being able to take enough of the drug, not to the cancer becoming resistant to the drug. If resistance was the issue, Tagrisso would be less likely to be effective because it goes after the same target as rociletinib.

I have more trial related news, but that is best saved for a new blog post as this one is quite long enough, and doesn’t even have any pretty pictures to accompany it.


  1. Thanks, Anita, for posting this. Very informative. I knew there was another reason I liked you! Our treatment dates coincided, starting in March 2015.

    I was on a clinical trial and I, too, got the boot. Developed pneumonia, landed in the hospital at home, a stay that resulted in a longer than allowed interval between chemo sessions. Fortunately, by then I had taken all the study drug, so I didn't miss any doses.

    I'm with you. I'd do another clinical trial, too. Very important.

    Good luck on your new drug! You're amazing.


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