Chemotherapy in Treating Patients Who Have Metastatic Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00003343
• Lead Sponsor: Pfizer

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether mitoxantrone and prednisone are more effective with or without prinomastat in treating patients with metastatic prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of mitoxantrone and prednisone with or without prinomastat in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES: I. Compare symptomatic progression free survival among patients having metastatic, hormone refractory prostate cancer receiving one of two doses of matrix metalloprotease inhibitor AG3340 or placebo initially in combination with mitoxantrone and prednisone with provision for subsequent change in therapy. II. Compare the symptomatic response, quality of life, serologic (PSA) response, PSA progression free survival, radiographic response, radiographic progression free survival, one year survival, and overall survival of these patients. III. Evaluate the safety of AG3340 in regimen combination and in combination with therapies administered subsequent to first line in this patient population. IV. Evaluate the population pharmacokinetics of AG3340 when given in this treatment regimen.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive the matrix metalloprotease inhibitor AG3340 (at one of two dosages) or placebo, orally twice a day, beginning on day 1. Patients receive mitoxantrone by intravenous infusion on day 1 and prednisone orally twice daily beginning on day 1. Treatment course is repeated every 3 weeks in the absence of unacceptable toxicity. Mitoxantrone and/or prednisone may be discontinued or switched at the investigator's discretion.

PROJECTED ACCRUAL: There will be 525 patients accrued into this study from approximately 50 centers.

Study Timeline

• Study Start: 1998-03
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-01
• Study First Submitted QC: 2004-07-15
• Study First Posted: 2004-07-16
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 525

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Agouron Pharmaceuticals, Inc.; 🇺🇸 La Jolla, California, United States