Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br>Paclitaxel 80 mg/m² Day 1, Day 8 and Day 15. No treatment on Day 22. 1 cycle = 28 days. Treatment duration: 6 cycles (=6 months) | Drug: paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 4 months | 
| Response rate |  | 6 months | 
| Tolerability |  | 6 months | 
| Time to progression |  | 5 years | 
| Overall survival |  | 5 years | 
| Clinical criteria predicting response |  | 2 months | 
| Correlation of efficacy with the expression of genes involved in the angiogenesis regulation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult angiosarcoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma