Changing the Rules

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!

9 responses to “Changing the Rules

  • Craig

    It sure would be disappointing to be bumped from a trial that is obviously effective despite the skips. FWIW, I wonder if it might be possible to try experimental ALK inhibitor Chugai CH5424802 on a “compassionate use” basis if they can’t get you into that trial according to their eligibility criteria. Being a different drug, maybe there’s a chance the side effects might be milder for you? You could probably discuss that idea with Alice if you haven’t already.

    Best hopes,


    • Jessica

      I appreciate that idea, Craig. I know that ALK trials are (right now) my best chance for continued survival, but the thought of trying another one turns my stomach!

      I must be the only person in the world who misses chemo.

  • Linda Forem

    Can I ask a personal question? When my sister had lung cancer, she had horrible shortness of breath and coughing. Do you find that you have symptoms like that? Honestly, I imagine you when you type your blog as well, telling a story about someone else. That is truly how I imagine you. And you mostly describe stomach pain from the treatments, but not breathing issues. I wonder this, because my sister had radiation on her lungs. Don’t know if you have had that…but avoid it if you can. It gave her pneumonitis, which was what ended her life. It truly sounds like your life is full and that you are stable and surving. I certainly pray that it continues. And, remember, EVERYTHING is negotiable. No matter what Novartis says, it is negotiable. So don’t ever take no for an answer. If you truly believe you should continue the treatment. Keep pushing them.
    All my best wishes, Linda…a huge fan of your wellbeing

    • Jessica

      Hi Linda,

      I do have some breathing issues, but I’ve become accustomed to many of them. Right now, with my cancer relatively stable, I only have trouble when I exert myself. (Too much walking, singing, etc.) When my cancer gets progresses, though, I have more trouble – sometimes just during conversation.

      Radiation is definitely NOT in my future. Not on my lungs, anyway. If I had a spot elsewhere they might want to treat it that way, but the idea of radiation scares me. I’ve read too many horror stories. We’ll just see what happens and hope I never need it.

      That’s interesting that you imagine me talking about someone else. I wonder why that is. Perhaps because I’m very matter-of-fact about many things. 🙂 I’ve always been practical, down-to-earth; often to a fault.

      Thanks for caring, thinking of me, and sharing your story too. Jessica

  • Sjoukje

    Hi Jessica!

    It is good to read that the treatment is somewhat stabilizing the cancer. I hope they will let you continue the trial if you should want to of course.

    I agree with Linda, don’t take no for an answer if you really want to stay in. But Im sure you will not just accept it 😉

    Sending you lots of love (and nosebonks) as always!

  • Patrick

    Hi Jessica and always thank you for sharing knowledge is power for all of us. As a newbie to the Stage 4 wars the best advice I have ever received is ‘take charge’ of you own care. … Parick

  • rinneron

    Good luck Jessica, I know bouncing among treatment options is really scary. I have a good friend who, after her 4th failed trial in a month and a half, finally started on standard chemo, which she’s tolerating pretty well. And if you come to Boston — that’s where I am! I can show you around. 🙂

  • Trinity

    The Plan E, the something you’ve forgotten about…is living life to the fullest with what time you have left and are capable to still, spend time with mom and loved ones as much as you can before you go, instead of fighting…having family watch you suffer, and regretting when you are incapable of mobility/conversation. I’m not saying that your decision to fight for prolonging life is wrong, but knowing it was incurable to begin with…the so called high quality of life or just creating memorable moments with loved ones should have been chosen instead of going “down the rabbit hole”. I support your decision because it’s your life but I hope you take time to reflect whether all this was really worth the time spent to conduct these lab rat tests.

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