Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 2

• Conditions: Prostate Cancer

• Registration Number: NCT00006114
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES:

* Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate.

* Determine the toxicities of this treatment regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2000-08-03
• Status Verified: 2000-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Last Update Submitted: 2011-02-26
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Hopital Saint-Louis; 🇫🇷 Amiens, France

Polyclinique De Courlancy; 🇫🇷 Reims, France

C.H. Senlis; 🇫🇷 Senlis, France

Hopital Perpetuel Secours; 🇫🇷 Levallois-Perret, France

Hopital Tenon; 🇫🇷 Paris, France

Hopital Laennec; 🇫🇷 Paris, France

Centre Hospitalier Intercommunal Toulon - La Seyne/Mer; 🇫🇷 Toulon - Cedex, France

Hopital Gouin; 🇫🇷 Clichy, France

Hopital Saint Antoine; 🇫🇷 Paris, France

CHU de la Timone; 🇫🇷 Marseille, France