Sarcoma Clinical Trial
Official title:
Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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