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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
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

January 24, 2003
January 27, 2003
September 24, 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 ClinicalTrials.gov 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
Not Provided
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: None (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 ClinicalTrials.gov 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
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