Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
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|ClinicalTrials.gov Identifier: NCT00014599|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
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 or disease||Intervention/treatment||Phase|
|Vulvar Cancer||Drug: paclitaxel||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||February 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014599
|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|