Vinorelbine in Treating Patients With Metastatic Prostate Cancer

June 24, 2019 updated by: Swiss Group for Clinical Cancer Research

Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonspital Aarau
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Basel, Switzerland, CH 4051
        • Office of Walter Weber-Stadelman
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Geneva, Switzerland, CH-1211
        • Hopital Cantonal Universitaire de Geneva
      • Lugano, Switzerland, CH-6900
        • Istituto Oncologico della Svizzera Italiana
      • Saint Gallen, Switzerland, CH-9007
        • Kantonsspital - Saint Gallen
      • Solothurn, Switzerland, 4500
        • Burgerspital, Solothurn
      • Zurich, Switzerland, 8063
        • City Hospital Triemli
      • Zurich, Switzerland, CH-8008
        • Klinik Hirslanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic stage IV prostate cancer Proven hormonal resistance Measurable or evaluable disease PSA at least 3 times upper limit of normal No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: WHO 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3500/mm3 OR Granulocyte count at least 2000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No acute severe infections No other neoplastic diseases except curatively treated basal cell or squamous cell carcinoma of the skin, or relapse free for more than 5 years after curative treatment of a neoplasm

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytostatic chemotherapy Endocrine therapy: At least 1 month since antiandrogens Prior hormonal therapy required Radiotherapy: No radiotherapy within the past 4 weeks No radiotherapy to the lesions used to evaluate activity of the study drug Surgery: Prior orchiectomy allowed Other: No other investigational drugs during the last month No prior therapy with cytostatic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Rudolf Morant, MD, Cantonal Hospital of St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Primary Completion (Actual)

September 1, 1999

Study Completion (Actual)

September 1, 1999

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 08/97
  • SWS-SAKK-08/97
  • EU-97042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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