paclitaxel in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.

objectives: primary * determine the 2-month objective response rate in patients with locally advanced or metastatic, unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with paclitaxel. secondary * determine the 4- and 6-month response rate in patients treated with this drug. * determine tolerability of this drug in these patients. * determine the time to disease progression and overall survival of patients treated with this drug. * determine the clinical criteria predicting response in patients treated with this drug. * correlate the efficacy of this drug with the expression of genes involved in angiogenesis regulation in these patients. outline: this is a multicenter study. patients receive paclitaxel iv on days 1, 8, and 15. treatment repeats every 28 days for up to 6 courses. projected accrual: a total of 15-30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed soft tissue angiosarcoma or lymphangiosarcoma * locally advanced or metastatic disease * unresectable disease * angiosarcomas in previously irradiated areas allowed provided disease is clearly progressive * measurable disease * no kaposi's sarcoma patient characteristics: age * 18 to 70 performance status * who 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count \> 1,500/mm\^3 * platelet count \> 100,000/mm\^3 hepatic * bilirubin \< 3 times upper limit of normal (uln) * sgot and sgpt \< 2.5 times uln * no severe liver failure renal * creatinine clearance \> 60 ml/min * no severe kidney failure cardiovascular * lvef ≥ 50% other * not pregnant or nursing * fertile patients must use effective contraception * no weight loss ≥ 20% of body weight prior to illness * patient must be amenable to receiving care during the day * no hiv positivity * no clinical neuropathy * no known allergy to study drug or to any of its components (e.g., cremophor el) * no other progressive malignant tumor * no chronic illness (somatic or psychiatric) that would preclude study compliance and follow-up * no psychological, geographical, or social reason that would preclude study follow-up prior concurrent therapy: biologic therapy * not specified chemotherapy * no more than 2 prior courses of chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics surgery * not specified other * no other concurrent anticancer therapy * no concurrent participation in another therapeutic investigational study

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