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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014599
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Condition or disease Intervention/treatment Phase
Vulvar Cancer Drug: paclitaxel Phase 2

Detailed Description:


  • 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 : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2001
Actual Primary Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer
Drug Information available for: Paclitaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • WHO 0-2
  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Not specified


  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT less than 2 times upper limit of normal


  • Creatinine clearance greater than 60 mL/min


  • 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)


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy except as concurrent therapy with radiotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • See Chemotherapy
  • No concurrent radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014599

Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Centre Henri Becquerel
Rouen, France, 76038
European Institute of Oncology
Milano, Italy, 20141
Ospedale Mauriziano Umberto I
Torino, Italy, 10128
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Ospedale Civile
Voghera, Italy, 27058
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3508 GA
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3001-301
United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, CH63 4JY
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Western Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Els Witteveen, MD, PhD UMC Utrecht

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00014599     History of Changes
Other Study ID Numbers: EORTC-55985
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III vulvar cancer
stage IV vulvar cancer
recurrent vulvar cancer
squamous cell carcinoma of the vulva

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action