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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Centre Henri Becquerel
Rouen, France
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European Institute of Oncology
Milan, Italy
Ospedale Mauriziano Umberto I
Torino, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Ospedale Civile
Voghera, Italy
Academisch Medisch Centrum
Amsterdam, Netherlands
University Medical Center Nijmegen
Nijmegen, Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands
...and 4 more locations