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.