Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Els Witteveen

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00014599
Information obtained from ClinicalTrials.gov on December 19, 2011

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