Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free rate at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as assessed by CTC 2.0 |  |  | 
| Response as assessed by RECIST criteria |  |  | 
| Time to onset of response |  |  | 
| Duration of response |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma