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About
RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Full description
OBJECTIVES:
Primary
Secondary
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.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed hormone-refractory metastatic prostate cancer
Measurable disease OR prostate-specific antigen level ≥ 10 ng/mL
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Estimated life expectancy ≥ 6 months
Absolute neutrophil count ≥ 1,500/mm³
Hemoglobin ≥ 8 g/dL
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
Bilirubin normal
AST, ALT, and alkaline phosphatase (AP) must meet 1 of the following criteria:
No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
No peripheral neuropathy > grade 1
No concurrent active infections
No concurrent major depression or suicidal ideation
No concurrent medical condition that would preclude study participation
No known HIV positivity
Fertile patients must use effective contraception during and for 10 weeks after completion of study therapy
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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