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Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy

This study has been completed.

Sponsored by: George Washington University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003622
  Purpose

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 plus paclitaxel in treating patients with metastatic prostate cancer that is refractory to hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: paclitaxel
Drug: vinorelbine ditartrate
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Vinorelbine    Vinorelbine tartrate    Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   January 1999
Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES: I. Determine the clinical benefit response (including improvement in quality of life) of vinorelbine and paclitaxel in patients with metastatic hormone-refractory prostate cancer. II. Correlate PSA response with clinical benefit response in these patients. III. Determine the objective response rate and duration of remission in patients with measurable disease treated with this regimen. IV. Further assess the toxicity of this combination in a cohort of prostate cancer patients. V. Examine the survival characteristics of these patients undergoing this regimen.

OUTLINE: This an open label study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 2, and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine. Course repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each treatment course. Patients are followed until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study over 15-30 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate that is hormone refractory Hormone-refractory defined as at least 50% increase in PSA while continuing hormonal therapy Must have received prior hormonal manipulation including either orchiectomy or LHRH agonist Must be symptomatic and on a stable dose of pain medication No documented CNS involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 1-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Renal: Creatinine no greater than 1.8 mg/dL Other: Not HIV positive No concurrent infection No concurrent medical or psychiatric illness that precludes study compliance No prior or concurrent second malignancy in the past 5 years except basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior antiandrogens If patients have received prior antiandrogens, PSA levels are reassessed at 4 week intervals until there is no decrease in PSA levels before registration into this study Radiotherapy: Prior radiotherapy allowed Must have recovered from prior radiotherapy Concurrent radiotherapy for symptomatic bone lesion allowed Surgery: Not specified Other: No other concurrent therapeutic study

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003622

Locations
United States, District of Columbia
George Washington University Hospital    
      Washington, District of Columbia, United States, 20037

Sponsors and Collaborators
George Washington University

Investigators
Study Chair:     James D. Ahlgren, MD     George Washington University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066701, GWCC-4097, GW-GWCC-4097, NCI-V98-1486
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003622
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate  
stage IV prostate cancer  
recurrent prostate cancer  

Study placed in the following topic categories:
Vinorelbine
Prostatic Diseases
Genital Neoplasms, Male
Paclitaxel
Vinblastine
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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