Spots Global Cancer Trial Database for Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva

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Trial Identification

Brief Title: Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva

Official Title: Phase II Clinical Trial On Taxol As Single Agent In Locally Advanced And/Or Metastatic Or Recurrent Vulva Cancer Not Amenable For Surgery And/Or Radiotherapy

Study ID: NCT00014599

Conditions

Vulvar Cancer

Interventions

paclitaxel

Study Description

Brief Summary: 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 paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.

Detailed Description: OBJECTIVES: * Determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva. * Determine the objective response rate and duration of response in these patients treated with this drug. * Determine the acute side effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 9 weeks. PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.