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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.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003622
First received: November 1, 1999
Last updated: February 26, 2011
Last verified: May 2008
  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 tartrate
Phase 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003622     History of Changes
Other Study ID Numbers: CDR0000066701, GWCC-4097, GW-GWCC-4097, NCI-V98-1486
Study First Received: November 1, 1999
Last Updated: February 26, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Paclitaxel
Vinorelbine
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014