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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Cliniques Universitaires Saint-Luc
Brussels, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Progression-free rate at 12 weeks
Toxicity as assessed by CTC 2.0
Response as assessed by RECIST criteria
Time to onset of response
Duration of response
Overall survival
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Institut Bergonie
Bordeaux, France
Centre Leon Berard
Lyon, France
CHU de la Timone
Marseille, France
Centre Antoine Lacassagne
Nice, France
Institut Curie - Section Medicale
Paris, France
Institut Gustave Roussy
Villejuif, France
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
...and 6 more locations