Vulvar Cancer
Conditions
Keywords
stage III vulvar cancer, stage IV vulvar cancer, recurrent vulvar cancer, squamous cell carcinoma of the vulva
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.
Interventions
DRUGpaclitaxel
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
Belgium, France, Italy, Netherlands, Portugal, United Kingdom
Outcome results
None listed