January 14, 2012

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?


  1. Karen2:57 PM

    Do they use your power port for PETs at Swedish? They never have used mine at SCCA. The tech told me power ports can be used for CT, but not PET because of the way they want the tracer to go through the body, but I might have misunderstood.

    I have had Premera and they covered everything at SCCA. While I understand hesitation about UW when you know someone who has had a bad experience, you can find folks with bad experiences at any hospital. I have been a UW patient since I was 18 years old and have loved all of my doctors there. I had all of my surgeries at UW hospital and a week-long stay there after my port infection as well. Nothing but great treatment, especially by the nursing staff. After my DIEP, they were amazing. I know that going to a new place would be scary, but do know that there are many of us who have had great experiences at SCCA and UW.

  2. Karen, on my blog I try to be candid about my dance with cancer. So when I have a tough experience, whether at Swedish, Minor and James (and there have been plenty) or SCCA, I put it out there for my family, friends and readers.

    Re using a power port for PET scans: the theory behind not using it has to do with trace amounts of dye being caught in the port and this showing up as a false positive for active disease. Since I have no disease that I know if in my chest wall, I have in the past been able to persuade technicians to use my power port for a PET scan.

    If the lead SCCA investigator will permit this under my special circumstances, it would make me more likely to participate in the trial. If she says no, regardless of what Dr G advises, I would be inclined to refuse to participate.

  3. Anonymous3:01 PM

    Participating in a clinical trial unfortunately means frequent scans. For the last 26 month I have CT scans every 6 weeks, but I am still stable(bone and liver mets).I also have a problems with the veins, but the nurses seem to be very creative and they somehow manage to get an IV going.
    It is great to hear that there is another drug being tried to resensitize AI. Side effects, you might have them or you might not. Everolimus(I am still on) is suppose to give you all kind of nasty SE. I have very few and that is nothing comparing to chemo.
    All my best.

  4. Jill, I'm sorry, I didn't mean to imply that you shouldn't be sharing your experiences. That was not my intention at all. I was only trying to reassure you that SCCA and UW have been wonderful to me and going there is not some sort of guarantee that you will have a bad experience.

    I was trying to be supportive, but I apologize if it did not come across that way.

  5. No worries, Karen. I am suposed to see Dr G today if the snow doesn't stop me from getting there. And then I'll know more about whether I will pursue this trial.

  6. Anonymous3:26 PM

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