NCT00052754

Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	gefitinib

Timeline

• Start date: 2002-10-01
• Primary completion: 2005-10-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

16 sites across 4 countries: Belgium, France, Netherlands, United Kingdom