Sarcoma
Conditions
Keywords
adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free rate at 12 weeks | — |
Secondary
| Measure | 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 | — |
Countries
Belgium, France, Netherlands, United Kingdom