Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
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
Sites / Locations
- Cliniques Universitaires Saint-Luc
- U.Z. Gasthuisberg
- Institut Bergonie
- Centre Leon Berard
- CHU de la Timone
- Centre Antoine Lacassagne
- Institut Curie - Section Medicale
- Institut Gustave Roussy
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Leiden University Medical Center
- Nijmegen Cancer Center at Radboud University Medical Center
- Daniel Den Hoed Cancer Center at Erasmus Medical Center
- Leeds Cancer Centre at St. James's University Hospital
- Royal Marsden NHS Foundation Trust - London
- Meyerstein Institute of Oncology at University College of London Hospitals
- Christie Hospital N.H.S. Trust