Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1|
- Progression-free rate at 12 weeks [ Designated as safety issue: No ]
- Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
- Response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to onset of response [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||October 2002|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052754
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Leuven, Belgium, B-3000|
|Bordeaux, France, 33076|
|Centre Leon Berard|
|Lyon, France, 69373|
|CHU de la Timone|
|Marseille, France, 13385|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Institut Curie - Section Medicale|
|Paris, France, 75248|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Nijmegen Cancer Center at Radboud University Medical Center|
|Nijmegen, Netherlands, NL-6500 HB|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Meyerstein Institute of Oncology at University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Royal Marsden NHS Foundation Trust - London|
|London, England, United Kingdom, SW3 6JJ|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Jean-Yves Blay, MD, PhD||Centre Leon Berard|