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.

Condition	Treatment or Intervention	Phase
stage III vulvar cancer stage IV vulvar cancer recurrent vulvar cancer squamous cell carcinoma of the vulva	Drug: paclitaxel  Procedure: chemotherapy	Phase II

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium; Recruiting
      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium; Recruiting
France
      Centre Henri Becquerel, Rouen,  76038,  France; Recruiting
Italy
      European Institute of Oncology, Milano,  20141,  Italy; Recruiting
      Ospedale Civile, Voghera,  27058,  Italy; Recruiting
      Ospedale di Circolo e Fondazione Macchi, Varese,  21100,  Italy; Recruiting
      Ospedale Mauriziano Umberto I, Torino,  10128,  Italy; Recruiting
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
      Academisch Ziekenhuis Utrecht, Utrecht,  3508 GA,  Netherlands; Recruiting
Portugal
      Hospitais da Universidade de Coimbra (HUC), Coimbra,  3001-301,  Portugal; Recruiting
United Kingdom, Scotland
      Western Infirmary, Glasgow,  Scotland,  G11 6NT,  United Kingdom; Recruiting

Study chairs or principal investigators

Els Witteveen, MD, PhD,  Academisch Ziekenhuis Utrecht   

Study ID Numbers:  CDR0000068565; EORTC-55985
Record last reviewed:  April 2001
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014599
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-17