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

Inclusion Criteria

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- Patients who have been recently withdrawn from treatment with bicalutamide or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