Ok. So. About that LDK378 trial…The gallery above is from my first day two weeks ago. Please note the woodchuck. And Sarah, giving me the high five after my lead-in dose. And how tired David looks; it was a very long day. Long enough that I had time to wander the halls, peruse the Wall of Hope and hang out in the lovely Healing Garden. Long enough that it was barely light when we left the house and quite dark when we returned home.
I’m going to directly lift from the Research Consent Form (a many paged document that you must read and sign prior to enrollment in a trial) to describe the specifics of day one:
PK run-in period (3days) in Part 1 of the study
Pharmacokinetics (PK) is the study of the actions of a drug in the body over a period of time (eg, how it is absorbed, distributed, broken down, and excreted).
The PK run-in is a 3 day period (before you begin daily study treatment with LDK378) where you will be given a single dose of LDK378 and then have repeated blood tests to see how your body handles the drug. (The tests are called pharmacokinetics or PK tests.) About 1/3 teaspoon of blood with be drawn at each PK blood draw.
- Day one of PK run-in: You will have blood drawn, take one dose of LDK378, and then have blood drawn 7 more times with the 8 hours after taking LDK378.
- Procedures performed on Day 1 of the PK run-in:
- Physical examination
- Vital signs
- In addition, blood pressure and heart rate will be measured before every PK blood sample is drawn.
- 3 consecutive EKGS after the single dose of LDK378 and another EKG 4 hours after the dose of LDK378.
- Additional blood for research blood test to measure biomarkers and the amount of circulating tumor cells in your blood (about 4 teaspoons). Biomarkers are substances such as proteins that may give information about how LDK378 is affecting your body.
So that is the technical run-down. In reality, it all felt rather festive. Just as my t-shirt proclaimed, this wasn’t my first rodeo and I kind of knew what to expect.
Not long after the first dose, I experienced some cramping and Irene performed anti-diarrhea acupuncture. That was it for drama; no other discernible side effects.
Wouldn’t it be wonderful if my personal history of lung cancer treatments someday represented the paradigm; thus far, they have only gotten easier and become more effective.
Consider: almost immediately following my diagnosis in 2005, I endured a rather brutal lower left lobectomy. That was followed by four grueling sessions of cisplatin and taxotere. In 2008 I spent two months taking tarceva with all of the side effects and none of the benefits.
And then came crizotinib (now Xalkori). Not only were the side effects minimal, it stamped out the cancer raging in my lungs and kept it at a low smolder for almost three years.
Will the LDK378 do the same? I am hopeful. The day after my lead-in dose, I was able to walk to the top of a steep hill without stopping numerous times to catch my breath; something I’d not been able to do for some time now. I felt great.
And then, I started to feel crappy again. Which is part of why I haven’t written yet.
However, before any conclusions are leapt to, I need to add that there were several extenuating circumstances. Two weeks before my lead-in dose, I had been on a ten day course of levaquin for a sinus infection. It was the first time I’d had antibiotics in months, and a curious thing happened.
The cough and accompanying rattle in my lungs, which had persisted almost since my bout with the flu, disappeared. I had assumed both symptoms were due to the progression of my lung cancer and was actually quite startled when they cleared up.
My lead-in dose was on a Wednesday, and I didn’t have another dose (the start of continual dosing) until the following Monday. In the meantime, the feeling of low level crappy returned; aches, chills, fatigue and a cough. What the hey!
Several months ago I found an imbedded deer tick but in subsequent days did not develop a bullseye rash. However, just to rule out lymes disease as a potential cause of my current symptoms, I was tested. In addition, my circulating hormone levels and thyroid were checked; all three were normal. Alice (Dr. Shaw) called on Sunday to see how I was feeling and mentioned that the pre trial PET scan had shown more uptake in my lungs than she had anticipated.We discussed the possibility of a smoldering low level pneumonia, as areas of inflammation can light up a PET scan and be confused with cancer. Finally, yesterday I saw the ENT to rule out a lingering sinus infection. My nasal passages were clear, but we decided it might be smart to go back on another ten days of levaquin and see what happens.
So here’s hoping. The side effects from the LDK378 would seem to be non-existent. If the antibiotics do their magic, perhaps I can really get back in the saddle again. I am so ready.