Saturday, November 14, 2009

Flavopiridol-Three Month Mark

On Thursday, November 12, 2009, I completed the third cycle of a planned six-cycle phase II clinical trial of Alvocidib (flavopiridol). Each cycle consists of four weeks of a one-day per week dosing, followed by a two-week 'holiday'.

As I've mentioned before, there is some thinking that as long as the drug is working, why stop it for two weeks every month? I concur with that thinking, especially if a continued pounding of CLL would conceivably result in a cure. However, flavopiridol has, per the latest published results of the trials ( using the drug, only resulted in one complete remission. The over-all response rate was 53%, most of which were partial remissions. There was one complete remission in this study, which I've not read has occurred in previous studies.

And I must admit the two-week holiday is something to look forward to. It would be different if I lived in San Diego, but I don't.

My own experience is that I have responded to the drug. My main complaint prior to enrollment in the trial was large abdominal lymph nodes. I was doing my best to treat the lymph nodes with 3 mg per day of EGCG (the green tea component) and what ever else I could think of (curcumin, PEITC through watercress, vitamin D3, exercise, etc.) Eventually the lymph nodes elsewhere in my body, which had remained very quiescent, started growing.

My blood numbers have remained quite low since my sad experience with FCR, so low, in fact, that I worry I may never recover what passes for normal bone marrow function in a CLL patient.

My lymph nodes (especially abdominal) have been my greatest complaint.

After three cycles of flavopiridol, what have I learned? This is not a terribly easy drug to take, although I have learned how to mitigate many of the side effects. The first problem is the terribly ill feeling I get the evening after getting the drug. I feel very sick, very nauseated, often vomit, have persistent diarrhea, and just plain feel terrible. I have an elevated heart rate as well. It is all I can do just to get into bed and ride it out. Several times I have felt so unwell that I had to go to the emergency room.

To counter the nausea, I've insisted and insisted on adequate anti-nausea medication, which is surprisingly difficult to get. I guess everything that is given on a clinical trial has to be per the protocol, or you don't get it (exceptions of course are made; people don't die because life-savings drugs aren't on the protocol). I take ativan prior to the start of the flavopiridol, and get injectable zofran. This helps; I also have ativan and zofran to take if I feel nauseated later in the day.

The diarrhea is a problem, since I fly from San Diego back to Sacramento the day after getting the drug. After some experimentation, I use Immodium at the first sign of problems, and I take yogurt for the probiotics after I get back home. This (so far) had made the problem more mild.

The fatigue is something all CLL patients are used to; you just rest and do what you can do. It only lasts for the rest of the second day. By the third day, I'm back to the generally low-level of energy which accompanies CLL.

As I mentioned in the last post, I avoid the diarrhea-inducing medicine at all costs. Just thinking of it, or seeing the bottle, or remembering the taste makes me ill and wanting to vomit. Bleech! So I go on a low-potassium diet for three days before the treatment; this has kept my potassium level below the magic 4.0 so far. However, this is a very restrictive diet; I have created a chart of a variety of foods with their potassium levels. This means no fruits, nochocolate, no potatoes, no tomatoes, no soy, no milk, no bananas, no meats of any kind, no carrots, no raisins, no yogurt, no bran, no multi-grain breads, no nuts, no orange juice, no beans, and so on.

You are allowed white bread, white cakes, white cookies, rice krispy bars, water, oils of any kind, and small portions of cheese, iceberg lettuce, olives, pasta, and most soft drinks. But it is worth it to avoid the diarrhea-producing drug!

So, at this point, both Dr. Kipps and I are satisfied with the results. Flavopiridol can work on heavily-pretreated patients with unfavorable prognostic indicators, such as me. Thank God (and the researchers and the pharmaceutical industry)!. Otherwise, who knows where I'd be right now...


Anonymous said...

Hi there, Just found your blog today. As it so happens I was searching on info about flavpiridol and your blog came up. Just got through with FCR and my counts are really a disaster 6 weeks later. I am interested in flavopiridol because of the recent successes for high risk CLL (me). I am sorry to hear about the terrible side effects, though and it sounds more dangerous than I had imagined. I encourage you to keep blogging because I will be following you and looking for new information - wishing you the best.

Barry B. said...

Well, the side effects are very manageable, considering the alternative (untreated CLL that is progressing??? You know where that leads...)

I would definitely say the side effects are not 'terrible'. It isn't a picnic, but I'd rather throw up than not be here!

My counts have not suffered, and that is very important, since I have low hemaglobin, low platelets, low white count etc.

I would recommend this treatment to others. Just keep in mind you will need to stay on top of things, and I would get nausea meds if nausea has been a problem or starts to be a problem.

With over a 50% response rate in hard to treat patients, this is something to consider. And, since it's available only in a clinical trial, the drug is free.