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.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate recurrent prostate cancer	Drug: MEN-10755  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Belgium
      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium
France
      Centre de Lutte Contre le Cancer, Georges-Francois Leclerc, Dijon,  21079,  France
      Centre Jean Perrin, Clermont-Ferrand,  63011,  France
      CHU de la Timone, Marseille,  13385,  France
      CHU Pitie-Salpetriere, Paris,  75651,  France
      Institut Bergonie, Bordeaux,  33076,  France
Germany
      Universitaets-Krankenhaus Eppendorf, Hamburg,  D-20246,  Germany
Israel
      Rabin Medical Center - Beilinson Campus, Petah-Tikva,  49100,  Israel
Spain
      Hospital Universitario 12 de Octubre, Madrid,  28041,  Spain
Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland

Study chairs or principal investigators

Walter Fiedler, MD,  Study Chair,  Universitaets-Krankenhaus Eppendorf   

Study ID Numbers:  CDR0000069067; EORTC-16006-30005; MAC-07
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027781
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08