Status:
TERMINATED
Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine the response rate, in terms of change in measurable disease or prostate-specific antigen levels, in patients with hormone-refractory metastatic prostate cancer treate...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed hormone-refractory metastatic prostate cancer
- Patients who have been recently withdrawn from treatment with bicalutamide or flutamide must demonstrate progression of disease
- 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:
- AP normal and AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- AP elevated and AST and ALT normal
- 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:
- Recovered from prior surgery or radiotherapy
- No prior chemotherapy, retinoids, or interferon therapy
- More than 4 weeks since prior flutamide
- More than 6 weeks since prior bicalutamide
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00176527
Start Date
November 1 2002
End Date
August 1 2007
Last Update
December 11 2009
Active Locations (1)
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1
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901