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



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

For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,Quality of Life,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): George Washington University ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JamesAhlgren,  Study Chair,  George Washington University

George Washington University Hospital
Washington D.C.,  District of Columbia,  20037
United States
 


Additional Information:
Study ID Numbers:  CDR0000066701;  GWCC-4097,NCI-V98-1486,GW-GWCC-4097
Study Start Date: January 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003622

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