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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Centre Paul Papin
Angers, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Objective Response Rate
Time frame: 2 months
Response rate
Time frame: 4 months
Response rate
Time frame: 6 months
Tolerability
Time frame: 6 months
Time to progression
Time frame: 5 years
Overall survival
Time frame: 5 years
Clinical criteria predicting response
Time frame: 2 months
Correlation of efficacy with the expression of genes involved in the angiogenesis regulation
Time frame: 6 months
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