The Vorinostat/FES clinical trial

Here's what I understand about the Vorinostat/FES phase II clinical trial, called Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy. Vorinostat, which the FDA approved to treat other cancers, is thought to resensitize estrogen receptors so I can benefit from an aromatase inhibitor again. (AI's are the drugs I took for the first seven years of living with mets.)

First cycleWeek 1
Baseline FDG PET (sugar-based glucose tracer) and FES (fluoroestradiol) scans, EKG, doctor visit
Begin Vorinostat (oral medication) 

Week 3
FDG PET (uses a sugar-based glucose tracer) and FES (fluoroestradiol) scans, doctor visit
Discontinue Vorinostat, begin aromatase inhibitor (AI) 

Week 8
FDG PET (uses a sugar-based glucose tracer) and FES (fluoroestradiol) scans, doctor visit
Discontinue aromatase inhibitor (AI) 

Second  (and subsequent) cyclesWeek 1
Begin Vorinostat (oral medication) 

Week 3
Discontinue Vorinostat, begin aromatase inhibitor (AI) 

Week 8
Discontinue aromatase inhibitor (AI), doctor visit, possible scans

As I understand it, this means a larger risk of exposure to radiation in the first cycle due to all the imaging. The 30-40% risk of side effects for Vorinostat including fatigue, diarrhea, nausea, vomiting, loss of appetite, weight loss, elevated blood sugar, altered taste, dry mouth, hair loss, constipation, muscle spasms, limb swelling, dizziness, headaches, shivering, fever, itching, kidney problems, cough, upper respiratory infection, lower number of red blood cells (anemia), lower platelets. These are mostly side effects associated with chemo that I have already experienced.

The study has enrolled four patients so far, of whom one was not helped by the treatment and dropped out of the study. The other three are in their third or fourth months os the study with manageable side effects so far. The study will enroll a total of 20 patients.

I need to contact Premera, my health insurance company, since the trial will not pay for standard labs, doctors' visits or the AI drug. I do not know if Premera will pay for any services at SCCA, since I normally receive my care through Swedish Medical Center and Minor and James Medical. The trial will pay for the Vorinostat, the baseline FDG PET scan, the interim FDG PET scans, and perhaps the concluding FDG PET scan. The trial covers all the FES PET scans.

This is also important, because if I enroll in this trial, while I am a participant, in the event of an emergency I would have to seek care at the UW Hospital. A close friend had terrible experiences there and I am not eager to find out for myself what that might be like.

During at least the first eight weeks of the trial Dr Gadi at SCCA would take over my care. He would keep Dr G in the loop, but Dr G would not be the main player as he has been since 1999. I would only enter the trial with Dr G's full support, but I also want to be able to return to his care after the first eight week cycle.

I asked the research coordinator to determine if SCCA would be able to use my power port for the PET scans. Since I have lymphedema in my left arm, I can't imagine having enough good veins in my right arm for a tech to be able to start IV lines several times in the course of a single week, or over two or eight weeks.

That's a lot of information. This is a big decision. Are there other questions I need to ask?

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