NCT00003682

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

Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	doxorubicin hydrochloride
DRUG	methylprednisolone

Timeline

• Start date: 1998-10-01
• Primary completion: 2001-03-01
• Completion: 2001-03-01
• First posted: 2004-01-27
• Last updated: 2016-06-23

Locations

15 sites across 1 country: France