gefitinib in treating patients with locally advanced or metastatic synovial sarcoma

Conditions: Sarcoma

Summary: 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.

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.

Eligibility criteria:
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

Keywords: adult synovial sarcoma stage iii adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage iv adult soft tissue sarcoma