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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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 Overview

Status

Completed

Conditions

Vulvar Cancer

Intervention / Treatment

Drug: paclitaxel

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Edegem, Belgium, B-2650
    - Universitair Ziekenhuis Antwerpen
  - Leuven, Belgium, B-3000
    - U.Z. Gasthuisberg
France
- - Rouen, France, 76038
    - Centre Henri Becquerel
Italy
- - Milano, Italy, 20141
    - European Institute of Oncology
  - Torino, Italy, 10128
    - Ospedale Mauriziano Umberto I
  - Varese, Italy, 21100
    - Ospedale di Circolo e Fondazione Macchi
  - Voghera, Italy, 27058
    - Ospedale Civile
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academisch Medisch Centrum
  - Nijmegen, Netherlands, NL-6500 HB
    - University Medical Center Nijmegen
  - Utrecht, Netherlands, 3508 GA
    - Academisch Ziekenhuis Utrecht
Portugal
- - Coimbra, Portugal, 3001-301
    - Hospitais da Universidade de Coimbra (HUC)
United Kingdom
- England
  - Merseyside, England, United Kingdom, CH63 4JY
    - Clatterbridge Centre for Oncology NHS Trust
  - Romford, England, United Kingdom, RM7 OBE
    - Oldchurch Hospital
- Scotland
  - Glasgow, Scotland, United Kingdom, G11 6NT
    - Western Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the vulva
- Not suitable for radiotherapy or surgery as first-line treatment
Measurable or evaluable disease
- At least 1 bidimensionally measurable target lesion
- Measurable metastatic disease outside previously irradiated areas OR
- Local recurrence within a previously treated area OR
- Local lesions showing progression while on treatment
No brain metastasis

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

WHO 0-2
ECOG 0-2

Life expectancy:

At least 3 months

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 1.5 mg/dL
AST/ALT less than 2 times upper limit of normal

Renal:

Creatinine clearance greater than 60 mL/min

Cardiovascular:

No prior or concurrent cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmia requiring medication, or 2nd or 3rd degree heart block)

Other:

No peripheral neuropathy greater than grade 1
No serious active infection
No prior allergic reaction to drugs containing Cremophor EL
No other serious medical, psychological, familial, or social condition that would preclude study
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy except as concurrent therapy with radiotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
See Chemotherapy
No concurrent radiotherapy

Surgery:

Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Study Chair: Els Witteveen, MD, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Witteveen PO, van der Velden J, Vergote I, Guerra C, Scarabeli C, Coens C, Demonty G, Reed N. Phase II study on paclitaxel in patients with recurrent, metastatic or locally advanced vulvar cancer not amenable to surgery or radiotherapy: a study of the EORTC-GCG (European Organisation for Research and Treatment of Cancer--Gynaecological Cancer Group). Ann Oncol. 2009 Sep;20(9):1511-1516. doi: 10.1093/annonc/mdp043. Epub 2009 Jun 1.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EORTC-55985

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.