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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: sabarubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sabarubicin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer