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