Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
Vulvar Cancer
About this trial
This is an interventional treatment trial for Vulvar Cancer focused on measuring stage III vulvar cancer, stage IV vulvar cancer, recurrent vulvar cancer, squamous cell carcinoma of the vulva
Eligibility 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
Sites / Locations
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- Centre Henri Becquerel
- European Institute of Oncology
- Ospedale Mauriziano Umberto I
- Ospedale di Circolo e Fondazione Macchi
- Ospedale Civile
- Academisch Medisch Centrum
- University Medical Center Nijmegen
- Academisch Ziekenhuis Utrecht
- Hospitais da Universidade de Coimbra (HUC)
- Clatterbridge Centre for Oncology NHS Trust
- Oldchurch Hospital
- Western Infirmary