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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Treatments: Sorafenib

Criteria

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)