District of Columbia
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.
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.
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
Washington, D.C., District of Columbia 20037
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