NCT00014599

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
6 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

4 years

First QC Date

April 10, 2001

Last Update Submit

September 20, 2012

Conditions

Vulvar Cancer

Keywords

stage III vulvar cancerstage IV vulvar cancerrecurrent vulvar cancersquamous cell carcinoma of the vulva

Interventions

paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (14)

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Ospedale Mauriziano Umberto I

Torino, 10128, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Ospedale Civile

Voghera, 27058, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3001-301, Portugal

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19487487RESULT

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Els Witteveen, MD, PhD

    UMC Utrecht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2001

First Posted

January 27, 2003

Study Start

February 1, 2001

Primary Completion

February 1, 2005

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

PT(1)BE(2)GB(3)FR(1)IT(4)NL(3)