In February 2015 I found myself sitting by myself in a car in a parking lot, summoning the courage to read the CT scan report I had just picked up to take to my oncologist. This scan marked the six month mark in my first line treatment with Tarceva. As I read the news that my cancer was starting to grow again, my heart sank. I had no time to wallow in my feelings, however - our daughter was getting married in our home and I was giving a sermon in our church in just a couple of weeks, and getting ready for these major life events took precedence.
By this time I had started to scour the internet for information about my particular type of lung cancer, and I knew that there were two new drugs in clinical trials being tested as treatments to use when Tarceva failed. It seemed to me that getting into one of those trials could be my best next treatment choice. After the dust settled from the wedding and sermon weekend, I started searching for more information. One night when I couldn’t sleep, I went online and found a website for the Clovis Pharmaceuticals’ TIGER trials for CO-1686, one of the two drugs of interest. The next day I called a toll-free number, and was sent information about a phase II trial available at Roswell Park Cancer Institute, a major cancer center that is only an hour and a half from my mother’s home. I took the information to my oncologist, she contacted Roswell with my medical records, and I started the enrollment process.
From initial referral to the day I took my first dose of the experimental drug took two months. Why so long? First there was a three week wait to get an appointment at Roswell after my initial referral due to preexisting plans to fly to California for a visit with my father and stepmother. The next step, a biopsy of a lymph node in my neck to see if I had the T790M mutation required for the trial, happened in late April 2015. After that, we waited for results. On May 15, I found out that I was positive for T790M and the trial was a go.
We had one more delay before I started treatment. I still needed a final screening of blood work, EKG, CT scans, and an MRI of my brain to confirm my eligibility for the trial and establish a baseline. My husband and I also had to make an important trip to Montreal, Quebec, to watch our daughter receive her PhD in statistics. We scheduled the final screening for a couple of days after our daughter’s graduation, and a week later, on June 11, 2015, I took my first dose of CO-1686.
The clinical trial established a rigid schedule for both my husband and me. I was required to visit my oncologist at Roswell every three weeks for an examination and tests. This was when I was given my next 3-week supply of the experimental drug. We made additional trips to Roswell for CT scans, which always happened the week before a clinic visit. Scans were every 6 weeks at the start, and later became every 9 weeks. There was no flexibility in that schedule, even as winter approached with the possibility of a poorly timed major snowstorm. We bought a set of new snow tires for our car to make sure that we would be there for every required visit.
Besides the tests I got in the hospital, I had a home testing requirement. Every day I had to test my blood sugar levels twice with a home testing kit. The sponsor provided the test kit and all other supplies I needed. As the trial progressed and my side effects stabilized, I only had to test once per day.
There was also paperwork. I signed a 26-page informed consent document at my very first visit to Roswell. Every visit included questionnaires and occasional new forms to sign, like an amendment to the informed consent, disclosing an increased risk of rapid onset cataracts. I had paperwork to do at home, as well. I filled in a daily log recording the time when I took each of my two daily doses, and I had a second daily log where I recorded my blood sugar levels and the time when I tested myself. These logs were turned in at the beginning of every clinic visit.
Clinic visits took a good part of a day. First I had fasting blood work, to the tune of 9 or more vials of blood being drawn for tests. Then we grabbed breakfast and I went to the Thoracic Center to see my trial coordinator and oncologist. I turned in my logs, got more blood test supplies, filled in paperwork, and was examined by my oncologist. After my doctor cleared me for the next step, I had a series of 3 EKGs. A nurse put electrodes around my heart area and on my arms and legs, and recorded my heart rhythm on a paper readout. If the EKGs were in an acceptable range, the nurse brought me three weeks worth of medication and I took a dose, along with lunch (this medicine had to be taken with food). We waited for two hours, reading and knitting. I then had another series of 3 EKGs. If they were OK, I was released for the day and we headed out for the 5-hour trip home.
By the time I enrolled in the trial, a few hundred patients had already taken CO-1686, and the doctors knew what side effects to expect, and how to treat them. That was a good thing, because I had all of the side effects. Within two weeks of starting the drug, I had blood sugar levels in the 300’s and 400’s, which is much higher than the normal level. Metformin did a lousy job of controlling my hyperglycemia (and made me feel even more lousy to boot). My family doctor collaborated with my trial doctor to help me with this side effect, and prescribed Jardiance, which stabilized my blood sugar in short order. I also had a problem with a change in my heart rhythm called QT interval prolongation. The only way to deal with that issue was dose reduction. After two dose reductions, I was no longer able to take enough of the experimental drug to control my cancer and on February 18, 2016, I left the trial. CO-1686 wasn’t done with me even then. A few months later I was diagnosed with rapid onset cataracts, and in late July and early August of 2016, I had cataract surgery in both eyes.
Those side effects may sound daunting, but I weathered them and felt pretty darn good once my blood sugar was under control. I am firmly convinced that being in this clinical trial extended my life. By the time I left the trial, the other drug being tested at the time I enrolled, AZD-9291, was FDA approved and on the market as Tagrisso. I slid on over to Tagrisso, and have had an additional year of good scans and a good life.
There are some things we can all take away from my personal experience in this particular lung cancer clinical trial. First of all, patients in clinical trials are closely followed, and side effects are addressed right away. In most trials, doctors are able to minimize side effects by adjusting dosages and prescribing additional drugs. Even between clinic visits, I was able to call Roswell at any time and get prompt attention to my medical needs. Secondly, patient safety is alway the top priority. Also keep in mind that each lung cancer clinical trial will be different for every patient who participates, and that experiences and side effects differ from patient to patient.
I had another remarkable experience as a result of participating in this trial: I was able to go to Washington DC, and make a statement about my patient experience on CO-1686 to the FDA’s Oncologic Drug Advisory Committee. I’ve written about that experience on my personal blog, and you can read it at this link: