Vinorelbine in Treating Patients With Metastatic Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00003259
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

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 vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these patients. III. Evaluate the quality of life of these patients, and correlate quality of life with PSA response.

OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course. Patients with stabilization of their disease, partial response, or complete response, receive a maximum of 12 courses of treatment. Patients showing disease progression or severe toxic side effects discontinue treatment. Quality of life and pain are assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.

Study Timeline

• Study Start: 1997-10
• Primary Completion: 1999-09
• Study Completion: 1999-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-30
• Study First Posted: 2004-08-02
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Istituto Oncologico della Svizzera Italiana; 🇨🇭 Lugano, Switzerland

Burgerspital, Solothurn; 🇨🇭 Solothurn, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland

Klinik Hirslanden; 🇨🇭 Zurich, Switzerland

University Hospital; 🇨🇭 Basel, Switzerland

Kantonsspital - Saint Gallen; 🇨🇭 Saint Gallen, Switzerland

Office of Walter Weber-Stadelman; 🇨🇭 Basel, Switzerland

Hopital Cantonal Universitaire de Geneva; 🇨🇭 Geneva, Switzerland