MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00027781
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
🇫🇷Dijon, France
CHU de la Timone
🇫🇷Marseille, France
CHU Pitie-Salpetriere
🇫🇷Paris, France
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Universitaets-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Institut Bergonie
🇫🇷Bordeaux, France