C1D8 – that’s clinical trial talk for Cycle 1 – Day 8. Felice and I are here in Houston and had a fun filled day yesterday at our favorite Houston Hang out – M.D. Anderson’s Clinical Translational Research Center (CTRC) also known as temporary lab rat cages :-).
I was approved to be a subject in Clinical Trial: NCT03093870.
What’s that mean? The first thing it means is that the care plan is driven by the requirements of the trial sponsor, in this case, Aslan Pharmaceuticals. They are recruiting 490 participants worldwide for this study. I believe that there are 11 trial sites in the US and MD Anderson has an allotment of 15 subjects.
The purpose of the trial is to determine if the combination of Varlitinib (trial drug) and Capecitabine (Xeloda) works better than Capecitabine alone.
All subjects in the study receive Xeloda. Half the participants will receive the trial drug – Varlitinib, the other half will receive a placebo. The only way that I’ll know if I’m receiving the trial drug will be certain side effects. It is a double blind study. The subject doesn’t know and the Doctor doesn’t know. Both drugs are oral. It involves taking 8 pills twice a day. Each cycle is 21 days. Xeloda is 14 days on, 7 days off. Varlitinib / placebo is daily.
During the first cycle, I come to Houston each week for observation and toxicity checks. The day starts early with labs. Then I meet with the research nurse. She coordinates the rats (aka subjects) for various clinical research projects that she has been assigned to. There is a huge amount of infrastructure that exists to support clinical trials. There is an entire unit, which I reference above – CTRC, that handles all of the trial patients, administering drugs, conducting data gathering, and works with the trial sponsors on executing the trials in accordance with the trial protocol. The trial sponsors, typically large pharmaceutical companies, pay big fees to the trial cites to conduct their studies. The sponsors need access to qualified subjects, MD Anderson and other research driven facilities are obvious partners. The hospitals gain their reputations off of the cutting edge treatments that they provide and luring patients which entrenches their position as key research partners. This particular trial has very specific criteria based on the nature of disease, general health of the subjects, the number of previous chemotherapy treatment attempts, etc.
Once I finish with the research nurse, Dr. Wolff comes in. He checks out my labs, does a quick physical, discusses how I am handling any side effects and approves me to continue on, or at least that is the plan. Once I’m done with the Doc, time to go check in to the CTRC. The rooms are really small – large enough for a bed, chair and TV. When the nurse, EKG tech, lab tech, Felice and I are all in there at the same time, there is no room to move. The observation process called for by the study is very precise. There needs to be a series of EKG’s completed 45 minutes prior to taking my dose of drugs. Then another series of EKG’s 5 minutes before the dose followed immediately by a blood draw and then take the drugs at a precise time. The nurse today was counting down the seconds until I took the dose, which appeared to be a little bit unnecessary. After taking the dose, EKG’s and blood draws at specific intervals occur over the following 8 hours. Fortunately, this extended observation period only occurs on D1 and D8. After the first couple weeks – the observation windows occur at various times, generally at the end of each cycle.
The biggest bureaucratic process is actually getting the drugs. They don’t begin to process the request at the pharmacy until the Doc has signed off on the subjects participation or continued participation. That order goes to the Investigational pharmacy. That is a pharmacy that is in a different location from the general hospital pharmacy. The investigational drugs are segregated from all other drugs. There is a laborious process of dispensing the investigational drugs, going through a triple check before they are sent over to the hospital pharmacy. All of this turns into wasted wait time for Felice and I. We can’t check into the observation area until I have physical possession of the drugs. On day 1, last week, it took almost three hours for the drugs to get to the pharmacy, which pushed back my observation time – we didn’t leave the hospital until right around midnight. So why the hell am I going through all of this? Chasing hope. Pretty simple. Dr. Wolff said that it is likely that Xeloda would be the next line of treatment that he would have suggested. His feeling was that my general health is strong, and while all tumor growth is concerning, the growth that was found in my scans last month didn’t represent an ‘oh shit’ discovery and I have the time to pursue the trial and see how it goes. His position is that it just broadens my ‘medicine cabinet’ and keeps other treatment options open.
If I receive the control drug (Varlitinib) and there is some type of strong response, the small inconveniences that go along with the trial bureaucracy will be worthwhile. I have had several people ask how long I will remain on the trial. The answer is – as long as it is working, assuming I am able to tolerate the side effects. What does ‘working’ mean? The definition of ‘working’ may be stabilization. Of course, my definition of ‘working’ is steady reduction of the new tumors and no new signs of progression until there is no evidence of disease. You leave the trial if you have disease progression, or if you are unable to tolerate the side effects of the drugs.
In the meantime, I’m just glad to be in treatment. It’s an awful feeling to have something growing inside of you and not doing anything about it for what appears to be an eternity – 3 weeks. Seriously, those that know me, know my temperament. Send me an email, I generally respond as it is landing in the inbox. Drop me a text and I’ll typically respond before you have hit send. Place a small tumor in my liver and wait 3 weeks to start trying to attack it? Are you kidding me?
I’m 15 doses into this treatment process. It takes some adjustment. I have to take the pills twice a day, take them shortly after eating something, and take them around the same time of day – within reason. I have to log each dose. This is on top of the other various things that I’m trying to do every day to support my health during treatment. A growing list of basic, daily tasks that either promote wellness or potentially stave off side effects. For the most part, I still feel great. I’ve had some subtle queasiness and experienced a very slight energy drop. Of course, my mind is also expecting side effects, so hard for me to differentiate between psychosomatic issues and real side effects. Regardless, there is no question that I feel a little different. The side effects of the drugs are cumulative, the hope is that I am able to tolerate the side effects. So far so good.
So we all know that cancer sucks. Treatment sucks. Having cancer and not being able to have treatment – that would really, really suck. So regardless of the inconvenience’s, the gradual onset of the side effects, make no mistake, I feel very, very fortunate to have treatment options and to feel pretty damn good. Whatever shortfall I have in terms of the way I feel is the chemo, it’s not the cancer. There is a huge difference in outlook between feeling ‘yuck’ because of chemo than feeling sick from disease.
I have run into so many people in the last several weeks that share their prayers and good wishes. Your prayers along with the text messages, emails, phone calls – all very much appreciated and make a huge difference!
Thanks for all your support! Mike. #cancersucks #ShaneStrong