Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva

Phase 2

Completed

• Conditions: Vulvar Cancer

• Registration Number: NCT00014599
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2001-04-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-02
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Ospedale di Circolo e Fondazione Macchi; 🇮🇹 Varese, Italy

Ospedale Mauriziano Umberto I; 🇮🇹 Torino, Italy

Ospedale Civile; 🇮🇹 Voghera, Italy

European Institute of Oncology; 🇮🇹 Milano, Italy

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

Centre Henri Becquerel; 🇫🇷 Rouen, France

Oldchurch Hospital; 🇬🇧 Romford, England, United Kingdom

Western Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom

Clatterbridge Centre for Oncology NHS Trust; 🇬🇧 Merseyside, England, United Kingdom

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Hospitais da Universidade de Coimbra (HUC); 🇵🇹 Coimbra, Portugal

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium