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Spots Global Cancer Trial Database for Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

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Trial Identification

Brief Title: Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Official Title: Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1

Study ID: NCT00052754

Conditions

Sarcoma

Interventions

gefitinib

Study Description

Brief Summary: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma.

Detailed Description: OBJECTIVES: * Determine the therapeutic activity of gefitinib, in terms of progression-free rate, in patients with locally advanced or metastatic synovial sarcoma expressing HER1. * Determine the toxicity of this drug in these patients. * Determine the objective response, in terms of time to onset and duration of response, in patients treated with this drug. * Determine the overall survival of patients treated with this drug. OUTLINE: This is a non-randomized, multicenter study. Patients receive oral gefitinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 18 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cliniques Universitaires Saint-Luc, Brussels, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

Institut Bergonie, Bordeaux, , France

Centre Leon Berard, Lyon, , France

CHU de la Timone, Marseille, , France

Centre Antoine Lacassagne, Nice, , France

Institut Curie - Section Medicale, Paris, , France

Institut Gustave Roussy, Villejuif, , France

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands

Leiden University Medical Center, Leiden, , Netherlands

Nijmegen Cancer Center at Radboud University Medical Center, Nijmegen, , Netherlands

Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, , Netherlands

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Royal Marsden NHS Foundation Trust - London, London, England, United Kingdom

Meyerstein Institute of Oncology at University College of London Hospitals, London, England, United Kingdom

Christie Hospital N.H.S. Trust, Manchester, England, United Kingdom

Contact Details

Name: Jean-Yves Blay, MD, PhD

Affiliation: Centre Leon Berard

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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