Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
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|ClinicalTrials.gov Identifier: NCT00052754|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: gefitinib||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||October 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Royal Marsden NHS Foundation Trust - London|
|London, England, United Kingdom, SW3 6JJ|
|Meyerstein Institute of Oncology at University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Jean-Yves Blay, MD, PhD||Centre Leon Berard|