Clinical Trial: Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1
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 Summary:
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.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Current Primary Outcome: Progression-free rate at 12 weeks
Original Primary Outcome:
Current Secondary Outcome:
- Toxicity as assessed by CTC 2.0
- Response as assessed by RECIST criteria
- Time to onset of response
- Duration of response
- Overall survival
Original Secondary Outcome:
Information By: European Organisation for Research and Treatment of Cancer - EORTC
Dates:
Date Received: January 24, 2003
Date Started: October 2002
Date Completion:
Last Updated: September 20, 2012
Last Verified: September 2012