Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer

Phase 3

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00003682
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES: I. Determine the effect of weekly doxorubicin on the quality of life of patients with metastatic, hormone-refractory, symptomatic prostate cancer. II. Determine the contribution of this treatment on control of pain in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the objective response and biological observations in these patients after this treatment. V. Determine the effect of this regimen on survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive methylprednisolone IV weekly for 3 months. Arm II: Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months. Quality of life is assessed before treatment, every 4 weeks during treatment, and then every 3 months. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study within 3 years.

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-03
• Study Completion: 2001-03
• Study First Submitted QC: 2004-01-26
• Study First Posted: 2004-01-27
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (15)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre de Lute Contre le Cancer,Georges-Francois Leclerc; 🇫🇷 Dijon, France

C.H.U. - Hopital Gaston Doumergue; 🇫🇷 Nimes, France

Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Centre Hospitalier General de Saint Nazaire; 🇫🇷 Saint Nazaire, France

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Hotel Dieu de Paris; 🇫🇷 Paris, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Leon Berard; 🇫🇷 Lyon, France