MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer|
|Study Start Date:||August 2001|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
- 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.
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Bordeaux, France, 33076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lutte Contre le Cancer, Georges-Francois Leclerc|
|Dijon, France, 21079|
|CHU de la Timone|
|Marseille, France, 13385|
|Paris, France, 75651|
|Hamburg, Germany, D-20246|
|Rabin Medical Center - Beilinson Campus|
|Petah-Tikva, Israel, 49100|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Bern, Switzerland, CH-3010|
|Study Chair:||Walter Fiedler, MD||Universitätsklinikum Hamburg-Eppendorf|