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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vulvar Cancer

Intervention / Treatment
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* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the vulva Not suitable for radiotherapy or surgery as first-line treatment Measurable or evaluable disease At least 1 bidimensionally measurable target lesion Measurable metastatic disease outside previously irradiated areas OR Local recurrence within a previously treated area OR Local lesions showing progression while on treatment No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT less than 2 times upper limit of normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: No prior or concurrent cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmia requiring medication, or 2nd or 3rd degree heart block) Other: No peripheral neuropathy greater than grade 1 No serious active infection No prior allergic reaction to drugs containing Cremophor EL No other serious medical, psychological, familial, or social condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except as concurrent therapy with radiotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy No concurrent radiotherapy Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III vulvar cancer, stage IV vulvar cancer, recurrent vulvar cancer, squamous cell carcinoma of the vulva