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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014599 |
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 | Intervention | Phase |
---|---|---|
Vulvar Cancer |
Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Open Label, 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the vulva
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Belgium | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
France | |
Centre Henri Becquerel | |
Rouen, France, 76038 | |
Italy | |
Ospedale Mauriziano Umberto I | |
Torino, Italy, 10128 | |
Ospedale Civile | |
Voghera, Italy, 27058 | |
Ospedale di Circolo e Fondazione Macchi | |
Varese, Italy, 21100 | |
European Institute of Oncology | |
Milano, Italy, 20141 | |
Netherlands | |
Academisch Ziekenhuis Utrecht | |
Utrecht, Netherlands, 3508 GA | |
University Medical Center Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Academisch Medisch Centrum | |
Amsterdam, Netherlands, 1105 AZ | |
Portugal | |
Hospitais da Universidade de Coimbra (HUC) | |
Coimbra, Portugal, 3001-301 | |
United Kingdom, England | |
Clatterbridge Centre for Oncology NHS Trust | |
Merseyside, England, United Kingdom, CH63 4JY | |
Oldchurch Hospital | |
Romford, England, United Kingdom, RM7 OBE | |
United Kingdom, Scotland | |
Western Infirmary | |
Glasgow, Scotland, United Kingdom, G11 6NT |
Investigator: | Els Witteveen, MD, PhD | University Medical Center Utrecht |
Study ID Numbers: | CDR0000068565, EORTC-55985 |
Study First Received: | April 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00014599 History of Changes |
Health Authority: | United States: Federal Government |
recurrent vulvar cancer squamous cell carcinoma of the vulva stage III vulvar cancer stage IV vulvar cancer |
Vulvar Cancer Genital Neoplasms, Female Urogenital Neoplasms Antimitotic Agents Squamous Cell Carcinoma Recurrence Carcinoma Genital Diseases, Female |
Vulvar Neoplasms Paclitaxel Epidermoid Carcinoma Tubulin Modulators Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Vulvar Diseases |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Genital Neoplasms, Female Urogenital Neoplasms Antimitotic Agents Pharmacologic Actions Genital Diseases, Female |
Neoplasms Neoplasms by Site Vulvar Neoplasms Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Vulvar Diseases |