Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
NCT ID: NCT00014599
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2001-02-28
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Els Witteveen, MD, PhD
Role: STUDY_CHAIR
UMC Utrecht
Locations
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Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Centre Henri Becquerel
Rouen, , France
European Institute of Oncology
Milan, , Italy
Ospedale Mauriziano Umberto I
Torino, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Ospedale Civile
Voghera, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-55985
Identifier Type: -
Identifier Source: secondary_id
EORTC-55985
Identifier Type: -
Identifier Source: org_study_id