|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014599 |
Purpose
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: | Treatment, 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 |
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.
Eligibility| 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:
Contacts and Locations| 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 Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3508 GA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| 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 |
More Information
| Study ID Numbers: | CDR0000068565, EORTC-55985 |
| Study First Received: | April 10, 2001 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00014599 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III vulvar cancer stage IV vulvar cancer recurrent vulvar cancer squamous cell carcinoma of the vulva |
|
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 |