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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.
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.
Age
18 - 85 years
Sex
MALE
Healthy Volunteers
No
Kantonspital Aarau
Aarau, Switzerland
Office of Walter Weber-Stadelman
Basel, Switzerland
University Hospital
Basel, Switzerland
Inselspital, Bern
Bern, Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland
Istituto Oncologico della Svizzera Italiana
Lugano, Switzerland
Kantonsspital - Saint Gallen
Sankt Gallen, Switzerland
Burgerspital, Solothurn
Solothurn, Switzerland
City Hospital Triemli
Zurich, Switzerland
Klinik Hirslanden
Zurich, Switzerland
Start Date
October 1, 1997
Primary Completion Date
September 1, 1999
Completion Date
September 1, 1999
Last Updated
June 26, 2019
40
ESTIMATED participants
vinorelbine tartrate
DRUG
Lead Sponsor
Swiss Cancer Institute
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494