Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES: * Assess the activity of MEN-10755 in patients with progressive hormone-refractory adenocarcinoma of the prostate. * Determine the rate and duration of objective PSA response in patients treated with this drug. * Determine the clinical response rate in patients with measurable disease treated with this drug. * Determine the acute side effects of this drug in these patients. OUTLINE: This is a multicenter study. Beginning within 2 weeks after the last PSA measurement, patients receive MEN-10755 IV over 30 minutes on day 1. Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response continue to receive additional courses. Patients who achieve stable disease may receive more than 4 courses at the discretion of the investigator. Patients are followed every 6 weeks until disease progression or initiation of a new therapy. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
Interventions
DRUGsabarubicin
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
Belgium, France, Germany, Israel, Spain, Switzerland
Outcome results
None listed