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

Primary Purpose

Vulvar Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Cancer focused on measuring stage III vulvar cancer, stage IV vulvar cancer, recurrent vulvar cancer, squamous cell carcinoma of the vulva

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Centre Henri Becquerel
  • European Institute of Oncology
  • Ospedale Mauriziano Umberto I
  • Ospedale di Circolo e Fondazione Macchi
  • Ospedale Civile
  • Academisch Medisch Centrum
  • University Medical Center Nijmegen
  • Academisch Ziekenhuis Utrecht
  • Hospitais da Universidade de Coimbra (HUC)
  • Clatterbridge Centre for Oncology NHS Trust
  • Oldchurch Hospital
  • Western Infirmary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00014599
Brief Title
Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
Keywords
stage III vulvar cancer, stage IV vulvar cancer, recurrent vulvar cancer, squamous cell carcinoma of the vulva

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Els Witteveen, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Ospedale Civile
City
Voghera
ZIP/Postal Code
27058
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Hospitais da Universidade de Coimbra (HUC)
City
Coimbra
ZIP/Postal Code
3001-301
Country
Portugal
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19487487
Citation
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.
Results Reference
result

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

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