I met with my entire clinical trial staff last Thursday: doctor, nurse, and nurse practitioner. When prompted, I explained how I felt in the three weeks since my last visit: rather crummy. When I entered the facility that morning I felt so-so; but by the time we met, abdominal pain had set in. We talked for quite some time. Witnessing the pain for themselves once again, they asked me how I wanted to proceed.
“I guess I’ll just keep doing this until I can’t take it any longer,” I said between the cramping. But my doctor had another idea.
The trial protocol allows participants to take a break for up to 21 days. She suggested a two-week break to allow my system to “reset.” I agreed to the plan. But there was more…
During a drug trial, the sponsor can revise the protocol whenever they wish. In other words, the drug company gets to change the rules because we’re playing in their sandbox. This time there were two changes that could potentially affect me: one positively and one negatively.
First, the potentially good news. The protocol was revised to allow continued treatment even if the cancer begins to grow in a particular area. It is my understanding that before this, you had to leave the trial if a metastasis was identified. If we find that the cancer has spread to my brain or some other place, I would be allowed to treat that area and return to the trial. (Odd to think of that as good news, eh?)
The bad news is a bit more black and white. Novartis has specified a point at which they feel a patient is not tolerating a drug and, therefore, should be kicked out of the trial. The new rule says the patient must take at least 75% of the doses each cycle.
A cycle is 21 days, so I would need to take it 15 or 16 days each cycle to meet the 75% requirement. During Cycle 9, I took LDK378 for 12 days. Cycle 8 was fewer than that.
My doctor is obligated to report this information to Novartis and see how they want to proceed. Since I’m still reacting positively to the medicine (my last scan showed stability), they may allow me to continue in the trial. But there is a chance they will conclude I’m not able to tolerate the drug and give me the boot.
Honestly, they would be right. I’m not tolerating it. But I’m still taking it because it has helped. And I still want the option to participate in the trial.
My doctor asked that I make an appointment with my primary oncologist to discuss my next steps. That was when I realized that getting kicked off is a real possibility. Of course, I’m also nearing the average duration of response (the amount of time the average person was helped by the drug). And that alone is a good reason to regroup.
Indeed, it’s time to figure out Plan E. Will I try another chemo option? Will I go to Boston for treatment? Or maybe there’s something else I’ve forgotten.
If I am allowed to stay in the trial, I’ll probably do another cycle to see how my next scan looks. Of course, by the end of this two-week break I could be feeling so good that I refuse to go back!