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

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Unknown status

CT.gov ID

NCT00874874

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: sorafenib tosylate	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2008

Anticipated Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Rate of non-progression at 9 months by RECIST criteria []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)