MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
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|ClinicalTrials.gov Identifier: NCT00027781|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2012
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: sabarubicin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|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|
|Actual Primary Completion Date :||March 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027781
|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|