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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Jean-Yves Blay, MD, PhD
Affiliation: Centre Leon Berard
Role: STUDY_CHAIR