A Phase II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (R.I.T.E.) for the Treatment of Hormone Refractory Prostate Cancer
- Determine the response rate, in terms of change in measurable disease or
prostate-specific antigen levels, in patients with hormone-refractory metastatic
prostate cancer treated with isotretinoin, recombinant interferon alfa-2b, docetaxel,
and estramustine phosphate sodium.
- Determine the effect of this regimen on bcl-2 family proteins in peripheral blood
mononuclear cell samples obtained from these patients.
OUTLINE: Patients receive oral isotretinoin once daily on days 1-4, recombinant interferon
alfa-2b subcutaneously once daily on days 1-4, oral estramustine phosphate sodium three
times daily on days 1-5, and docetaxel IV over 1 hour on day 2. Treatment repeats every 21
days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2, 3,
or 4 and analyzed for bcl-2 protein by IHC and electrophoresis.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Response (biochemical and measurable disease)
Robert S. DiPaola, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|