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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer
Eligibility Criteria
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
Sites / Locations
- Universitair Ziekenhuis Antwerpen
- Institut Bergonie
- Centre Jean Perrin
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
- CHU de la Timone
- CHU Pitie-Salpetriere
- Universitaets-Krankenhaus Eppendorf
- Rabin Medical Center - Beilinson Campus
- Hospital Universitario 12 de Octubre
- Inselspital, Bern