Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
NCT ID: NCT00052754
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2002-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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gefitinib
Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC greater than 3,000/mm\^3
* Granulocyte count greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Albumin at least 25 g/L
Renal
* Creatinine no greater than 2 times ULN OR
* Creatinine clearance greater than 65 mL/min
Cardiovascular
* No history of severe cardiovascular disease
Pulmonary
* No evidence of clinically active interstitial lung disease
* Asymptomatic chronic stable radiographic changes allowed
Other
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 28 days since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* 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
Surgery
* Not specified
Other
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Jean-Yves Blay, MD, PhD
Role: STUDY_CHAIR
Centre Leon Berard
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Institut Curie - Section Medicale
Paris, , France
Institut Gustave Roussy
Villejuif, , France
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
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Royal Marsden NHS Foundation Trust - London
London, England, United Kingdom
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-62022
Identifier Type: -
Identifier Source: secondary_id
EORTC-62022
Identifier Type: -
Identifier Source: org_study_id