exatecan mesylate in treating patients with advanced soft tissue sarcoma

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma.

objectives: * determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma. * determine the safety of this drug in these patients. outline: this is a multicenter study. patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies). patients receive exatecan mesylate iv over 30 minutes daily on days 1-5. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 6 weeks until disease progression. after disease progression, patients are followed every 12 weeks for survival. projected accrual: a total of 32-50 patients (16-25 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed soft tissue sarcoma * malignant fibrous histiocytoma * liposarcoma * rhabdomyosarcoma * synovial sarcoma * malignant paraganglioma * fibrosarcoma * leiomyosarcoma * angiosarcoma including hemangiopericytoma * malignant peripheral nerve sheath tumor * unclassified sarcoma * miscellaneous sarcoma including mixed mesodermal tumors of the uterus * the following tumor types are excluded: * gastrointestinal stromal tumor * chondrosarcoma * malignant mesothelioma * neuroblastoma * osteosarcoma * ewing's sarcoma * embryonal rhabdomyosarcoma * prior chemotherapy for metastatic disease required * one line of combination chemotherapy containing anthracycline or * no more than 2 single-agent regimens including anthracycline * adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment * must have 1 measurable lesion * clinical evidence of progression within 6 weeks prior to study * osseous lesions and pleural effusions not considered measurable * no known or symptomatic cns metastases patient characteristics: age: * 15 to 75 performance status: * who 0-1 life expectancy: * not specified hematopoietic: * wbc at least 4,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.8 mg/dl * albumin at least 2.5 g/dl renal: * creatinine no greater than 1.4 mg/dl or * creatinine clearance greater than 65 ml/min cardiovascular: * no history of severe cardiovascular disease other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for up to 6 months after study participation * no other severe medical illness, including psychosis * no other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * more than 4 weeks since prior chemotherapy * no other concurrent cytotoxic therapy endocrine therapy: * not specified radiotherapy: * no radiotherapy to the sole measurable lesion * no concurrent radiotherapy surgery: * not specified other: * no other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug * no other concurrent anticancer therapy

Keywords: adult angiosarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma adult neurofibrosarcoma adult synovial sarcoma stage iv adult soft tissue sarcoma recurrent adult soft tissue sarcoma adult malignant fibrous histiocytoma adult malignant hemangiopericytoma adult rhabdomyosarcoma stage iv uterine sarcoma recurrent uterine sarcoma uterine leiomyosarcoma