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Vinorelbine in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
vinorelbine tartrate
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonspital Aarau
  • Office of Walter Weber-Stadelman
  • University Hospital
  • Inselspital, Bern
  • Hopital Cantonal Universitaire de Geneva
  • Istituto Oncologico della Svizzera Italiana
  • Kantonsspital - Saint Gallen
  • Burgerspital, Solothurn
  • City Hospital Triemli
  • Klinik Hirslanden

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 24, 2019
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00003259
Brief Title
Vinorelbine in Treating Patients With Metastatic Prostate Cancer
Official Title
Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
September 1999 (Actual)
Study Completion Date
September 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Morant, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Office of Walter Weber-Stadelman
City
Basel
ZIP/Postal Code
CH 4051
Country
Switzerland
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneva
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Istituto Oncologico della Svizzera Italiana
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Kantonsspital - Saint Gallen
City
Saint Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Burgerspital, Solothurn
City
Solothurn
ZIP/Postal Code
4500
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zurich
ZIP/Postal Code
CH-8008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
12142053
Citation
Morant R, Hsu Schmitz SF, Bernhard J, Thurlimann B, Borner M, Wernli M, Egli F, Forrer P, Streit A, Jacky E, Hanselmann S, Bauer J, Hering F, Schmid HP. Vinorelbine in androgen-independent metastatic prostatic carcinoma--a phase II study. Eur J Cancer. 2002 Aug;38(12):1626-32. doi: 10.1016/s0959-8049(02)00145-4.
Results Reference
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Vinorelbine in Treating Patients With Metastatic Prostate Cancer

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