Sarcoma Clinical Trial
Official title:
Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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