Sarcoma
Conditions
Keywords
stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult angiosarcoma
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.
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of non-progression at 9 months by RECIST criteria | — |
Countries
France
Contacts
Centre Oscar Lambret