Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||February 2001|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
- 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.
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|European Institute of Oncology|
|Milano, Italy, 20141|
|Ospedale Mauriziano Umberto I|
|Torino, Italy, 10128|
|Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Voghera, Italy, 27058|
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Hospitais da Universidade de Coimbra (HUC)|
|Coimbra, Portugal, 3001-301|
|Clatterbridge Centre for Oncology NHS Trust|
|Merseyside, England, United Kingdom, CH63 4JY|
|Romford, England, United Kingdom, RM7 OBE|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Els Witteveen, MD, PhD||UMC Utrecht|