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

Vulvar Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014599
• Other study ID #: EORTC-55985
• Secondary ID: EORTC-55985
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2001
• Last updated: September 20, 2012
• Start date: February 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
France	Centre Henri Becquerel	Rouen
Italy	European Institute of Oncology	Milano
Italy	Ospedale Mauriziano Umberto I	Torino
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Italy	Ospedale Civile	Voghera
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Academisch Ziekenhuis Utrecht	Utrecht
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
United Kingdom	Western Infirmary	Glasgow	Scotland
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Oldchurch Hospital	Romford	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Netherlands,  Portugal,  United Kingdom, 

References & 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 EOR — View Citation