Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis

Inclusion Criteria

• Patients must have confirmation of DT/DF by local pathologist prior to registration
• Patients may have been treated with locoregional therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery provided this has been completed at least 4 weeks prior to registration and recovered from therapy related toxicity to less than CTCAE grade 2
• Patients may have been treated with cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least 4 weeks prior to registration (6 weeks for mitomycin and nitrosoureas) and recovered from any therapy related toxicity to less than CTCAE grade 2
• Patients with prior or current treatment of sorafenib are excluded
• No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (= = 3 days prior to registration; NSAIDS are allowed when used for desmoid tumor-related pain or for symptoms that are unrelated to desmoid disease (eg. headache, arthritis)
• Patients must have measurable disease
• Patients have to meet one of the following criteria to be eligible:
• Disease determined unresectable or entailing unacceptably morbid surgery based on 1 or more of the following characteristics:
• Multifocal disease
• Disease in which there is involvement or inadequate plane from: neurovascular bundle, bone, skin, or viscera
• Large size in relationship to location OR multi-compartment involvement
• Progression by radiographic imaging (10% increase in size by RECIST v1.1 within 6 months of registration)
• Patients with symptomatic disease which meets the following criteria Brief Pain Inventory (BPI) score greater than or equal to 3 AND one of the following:
• Inability to control pain with NSAIDs and considering addition of narcotics OR
• > 30% increase in current use of narcotics OR
• Addition of a new opioid narcotic
• Eastern Cooperative Oncology Group (ECOG) performance status = class II New York Heart Association (NYHA); active coronary artery disease (CAD) (myocardial infarction or unstable angina within 6 months prior to study entry)
• No patients with inadequately controlled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic), or any prior history of hypertensive crisis or hypertensive encephalopathy
• No patients with clinically significant gastrointestinal (GI) bleeding or bleeding diathesis within 30 days prior to registration
• Absolute neutrophil count >= 1,500/mm^3
• Hemoglobin >= 8 g/dl
• Platelets >= 75,000/mm^3
• Total bilirubin = = 50 mL/min using the Cockcroft-Gault equation