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Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

This study has been completed.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC Identifier:
First received: January 24, 2003
Last updated: September 20, 2012
Last verified: September 2012

January 24, 2003
September 20, 2012
October 2002
October 2005   (Final data collection date for primary outcome measure)
Progression-free rate at 12 weeks
Not Provided
Complete list of historical versions of study NCT00052754 on Archive Site
  • Toxicity as assessed by CTC 2.0
  • Response as assessed by RECIST criteria
  • Time to onset of response
  • Duration of response
  • Overall survival
Not Provided
Not Provided
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Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
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.


  • 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.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
Drug: gefitinib
Not Provided
Ray-Coquard I, Le Cesne A, Whelan JS, Schoffski P, Bui BN, Verweij J, Marreaud S, van Glabbeke M, Hogendoorn P, Blay JY. A phase II study of gefitinib for patients with advanced HER-1 expressing synovial sarcoma refractory to doxorubicin-containing regimens. Oncologist. 2008 Apr;13(4):467-73. doi: 10.1634/theoncologist.2008-0065.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
October 2005   (Final data collection date for primary outcome measure)


  • Histologically proven advanced or metastatic synovial sarcoma that is not amenable to surgery, radiotherapy, or combined modality treatment with curative intent
  • HER1 antigen expression
  • Must have received at least 1 prior chemotherapy regimen comprising doxorubicin and/or ifosfamide
  • At least 1 measurable lesion with evidence of progression within 3 months of study

    • Osseous lesions and pleural effusions are not considered measurable
  • No symptomatic or known CNS metastases



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • WBC greater than 3,000/mm^3
  • Granulocyte count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Albumin at least 25 g/L


  • Creatinine no greater than 2 times ULN OR
  • Creatinine clearance greater than 65 mL/min


  • No history of severe cardiovascular disease


  • No evidence of clinically active interstitial lung disease

    • Asymptomatic chronic stable radiographic changes allowed


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No known severe hypersensitivity to gefitinib or any of its excipients
  • No other primary malignant tumor except adequately treated carcinoma in situ of the cervix, basal cell skin cancer, or any other malignant tumor in complete remission for at least 3 years
  • No other severe medical illness
  • No psychosis
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • At least 28 days since prior chemotherapy and recovered

Endocrine therapy

  • Not specified


  • At least 3 months since prior radiotherapy to measurable lesion and recovered
  • No concurrent radiotherapy for soft tissue sarcoma
  • Concurrent palliative radiotherapy to nontarget lesions allowed


  • Not specified


  • More than 28 days since prior unapproved or investigational drugs and recovered
  • No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's Wort)
  • No other concurrent cytostatic agents
  • No other concurrent tyrosine kinase activity inhibitors
  • No other concurrent systemic therapy for soft tissue sarcoma
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Netherlands,   United Kingdom
Not Provided
Not Provided
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Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Jean-Yves Blay, MD, PhD Centre Leon Berard
European Organisation for Research and Treatment of Cancer - EORTC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP