MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy

DISEASE CHARACTERISTICS:

• Histologically confirmed hormone-refractory adenocarcinoma of the prostate
• Disease progression while on prior luteinizing hormone-releasing hormone (LHRH) analogues or after orchiectomy and antiandrogens, given concurrently or consecutively

• Disease progression is defined as PSA progression documented by increases in PSA recorded at 2 consecutive measurements over a prior reference value

  • Interval of at least 1 week between the reference value and the first of these two PSA increases
• Continued elevation of PSA for at least 6 weeks after discontinuation of antiandrogens
• Last PSA value at least 5 ng/mL (Hybritech equivalent)
• Must have serum testosterone less than 50 ng/mL and must continue on LHRH agonist therapy if no prior surgical castration
• No symptomatic brain or leptomeningeal metastatic disease

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal:

• Creatinine no greater than 1.7 mg/dL
• No uncontrolled hypercalcemia

Cardiovascular:

• No history of severe heart disease
• No myocardial infarction within the past 6 months
• No cardiac insufficiency
• Normal cardiac function by MUGA scan and 12-lead EKG

Other:

• No other prior or concurrent malignancy except basal cell or squamous cell skin cancer
• No uncontrolled systemic nonmalignant disease or infection
• No psychological, familial, or geographical conditions that would preclude compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• See Disease Characteristics
• No prior hormonal therapy except estramustine
• No concurrent estramustine

Radiotherapy:

• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy (e.g., for painful bone metastases)

Surgery:

• See Disease Characteristics

Other:

• No other concurrent experimental drugs or investigational therapy