Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery

Study Overview
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Brief Summary
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RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

Detailed Description
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OBJECTIVES: Primary Determine the rate of non-progression at 9 months in patients with unresectable, locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate. Secondary Determine the rate of non-progression at 60, 120, and 180 days. Determine the median time to progression. Determine overall survival. Determine the best response rate. Determine the clinical and biological factors that predict clinical benefit. Evaluate tolerability by NCI CTCAE v3.0. Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis. Explore the tumor expression of these genes in tissue from a tumor bank. OUTLINE: This is a multicenter study. Patients are stratified according to disease type (cutaneous angiosarcoma [scalp, breast, or soft tissue] vs visceral angiosarcoma). All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity.

Official Title
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Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: sorafenib tosylate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed angiosarcoma Locally advanced or metastatic disease Unresectable disease No Kaposi sarcoma, hemangiopericytoma, or hemangioendothelioma Measurable tumor with at least 1 measurable lesion by RECIST criteria Tumor in a previously irradiated area must not show progression No brain metastases or meningeal tumors (symptomatic or asymptomatic) PATIENT CHARACTERISTICS: WHO performance status 0-2 Life expectancy ≥ 3 months WBC ≥ 3,000/mm³ ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL PT or INR and aPTT ≤ 1.5 times upper limit of normal (ULN) Anticoagulation treatment with heparin or vitamin K allowed if the above criteria are met Liver transaminases ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases) Total bilirubin ≤ 1.5 times ULN Serum creatinine ≤ 1.5 times ULN Amylase and lipase ≤ 1.5 times ULN Not pregnant or nursing Weight loss from pre-disease weight < 20% over the past 12 months Able to swallow No active or ischemic coronary artery disease No myocardial infarction within the past 6 months No NYHA class III-IV cardiac failure No uncontrolled hypertension No coagulopathy No active uncontrolled peptic ulcer No patients on renal dialysis No active bacterial or fungal infection > CTCAE v3.0 grade 2 No HIV or hepatitis B or C positivity No chronic unstable illness that could jeopardize patient safety or compliance No other progressive or malignant tumor No known or suspected allergy to sorafenib tosylate No psychological, familial, social, or geographic situations that preclude clinical follow up No patients deprived of liberty or under guardianship No cardiac arrhythmia requiring antiarrhythmic medication (except beta-blockers or digoxin for chronic atrial fibrillation) No epilepsy requiring antiepileptic drugs PRIOR CONCURRENT THERAPY: See Patient Characteristics No prior organ or peripheral stem cell transplantation No more than 2 prior lines of chemotherapy At least 28 days since prior treatment (systemic or major surgery) No concurrent therapy for another malignancy No concurrent CYP3A inducers (e.g., rifampicin, St. John wort, phenytoin, carbamazepine, phenobarbital, dexamethasone)

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sorafenib tosylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of non-progression at 9 months by RECIST criteria |  |  | 

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