Clinical trial NCT00014599: Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvar Cancer
Keywords: stage III vulvar cancer
stage IV vulvar cancer
recurrent vulvar cancer
squamous cell carcinoma of the vulva
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Milano
country: Italy
facility: European Institute of Oncology
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Voghera
country: Italy
facility: Ospedale Civile
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Utrecht
country: Netherlands
facility: Academisch Ziekenhuis Utrecht
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra (HUC)
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Romford
country: United Kingdom
facility: Oldchurch Hospital
state: England
city: Glasgow
country: United Kingdom
facility: Western Infirmary
state: Scotland
Study officials:
affiliation: UMC Utrecht
name: Els Witteveen, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.