Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Phase 2

Completed

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Progression-free rate at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Toxicity as assessed by CTC 2.0
Response as assessed by RECIST criteria
Time to onset of response
Duration of response
Overall survival

Locations (16): U.Z. Gasthuisberg
🇧🇪
Leuven, Belgium
Centre Antoine Lacassagne
🇫🇷
Nice, France
Centre Leon Berard
🇫🇷
Lyon, France
Institut Gustave Roussy
🇫🇷
Villejuif, France
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱
Rotterdam, Netherlands
Meyerstein Institute of Oncology at University College of London Hospitals
🇬🇧
London, England, United Kingdom
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱
Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱
Leiden, Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
🇳🇱
Nijmegen, Netherlands
Institut Curie - Section Medicale
🇫🇷
Paris, France
Institut Bergonie
🇫🇷
Bordeaux, France
Christie Hospital N.H.S. Trust
🇬🇧
Manchester, England, United Kingdom
Cliniques Universitaires Saint-Luc
🇧🇪
Brussels, Belgium
CHU de la Timone
🇫🇷
Marseille, France
Royal Marsden NHS Foundation Trust - London
🇬🇧
London, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧
Leeds, England, United Kingdom