- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014599
Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
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
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Rouen, France, 76038
- Centre Henri Becquerel
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Milano, Italy, 20141
- European Institute of Oncology
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Torino, Italy, 10128
- Ospedale Mauriziano Umberto I
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Varese, Italy, 21100
- Ospedale di Circolo e Fondazione Macchi
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Voghera, Italy, 27058
- Ospedale Civile
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Amsterdam, Netherlands, 1105 AZ
- Academisch Medisch Centrum
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Nijmegen, Netherlands, NL-6500 HB
- University Medical Center Nijmegen
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Utrecht, Netherlands, 3508 GA
- Academisch Ziekenhuis Utrecht
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Coimbra, Portugal, 3001-301
- Hospitais da Universidade de Coimbra (HUC)
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England
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Merseyside, England, United Kingdom, CH63 4JY
- Clatterbridge Centre for Oncology NHS Trust
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Romford, England, United Kingdom, RM7 OBE
- Oldchurch Hospital
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Scotland
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Glasgow, Scotland, United Kingdom, G11 6NT
- Western Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Els Witteveen, MD, PhD, UMC Utrecht
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-55985
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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