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Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James D. Ahlgren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

George Washington University


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



George Washington University Hospital Washington, District of Columbia  20037