Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Other EORTC-55985 NCT00014599

Objectives

1. Determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva.
2. Determine the objective response rate and duration of response in these patients treated with this drug.
3. Determine the acute side effects of this drug in these patients.

Entry 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

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

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

Expected Enrollment

A total of 16-29 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Els Witteveen, MD, PhD, Study coordinator		Ph: 30-2506265 Email: p.o.witteveen@umcutrecht.nl

Registry Information
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
Trial Start Date		2001-02-07
Registered in ClinicalTrials.gov		NCT00014599
Date Submitted to PDQ		2001-02-27
Information Last Verified		2005-02-23

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