- Male 18 years of age.
- Histologically confirmed adenocarcinoma of the prostate, stage D1 or D2.
- Failure of androgen ablation (orchiectomy or LHRH, flutamide).
- Patients must have PSA progression and progression in measurable disease.
- No prior history of systemic chemotherapy.
- No investigational drugs within 4 weeks of study entry.
- No radiation therapy or hormonal therapy within 4 weeks of study entry.
- No isotope therapy within 6 weeks of study entry.
- No antiandrogens within 4 weeks of study entry. Patients must continue LHRH.
- If patients had prior surgery, it must be at least 21 days prior to study entry, and
the patient must have recovered from all side effects.
- Patients must have stopped bisphosphonates 28 days prior to study entry.
- No prior malignancy allowed except for adequately treated basal cell or squamous cell
skin cancer, or adequately treated stage I or II cancer from which the patient is
currently in remission, and has been disease free for at least 5 years.
- Patients must have recovered from major infections and/or surgical procedures, and in
the opinion of the investigator not have significant active concurrent medical
illness, such as a history of significant neurologic or psychiatric disorders
including psychotic disorders, dementia, or seizures that would preclude protocol
treatment or survival.
- All patients must be informed of the investigational nature of the study and must
sign and give written informed consent in accordance with institutional and federal
- No other chemotherapeutic, biological response modifiers, radiation therapy,
corticosteroid therapy, or hormonal concomitant therapy (except continuation of LHRH)
may be given during treatment. Patients should not be planning on receiving
- ECOG Performance Status = 0-3.
- WBC > or = 3500/ul or ANC > or = 1500/ul.
- Bilirubin < or = ULN.
- Creatinine < or = 2.0 mg/dl.
- Platelets > or = 100,000/ul.
- ALT or AST < 2.5 X ULN.