Sorafenib Tosylate in Treating Patients With Liver Cancer That Can Be Removed by Surgery

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

Summary

RATIONALE: Sorafenib tosylate 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 tosylate works in treating patients with liver cancer that can be removed by surgery.

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

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Niacinamide; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed hepatocellular carcinoma (HCC)

• Fibrolamellar or mixed histology allowed

• No cholangiocarcinoma or other tubal disease

• Must be eligible for conservative hepatic resection or liver resection with curative intent

• No cirrhosis with Child-Pugh score > 7

• Chronic liver disease without liver insufficiency and without portal liver hypertension allowed

• No known history or presence of metastatic brain or meningeal tumors

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Life expectancy ≥ 3 months

• WBC > 3,000/µL

• ANC > 1,500/µL

• Platelet count ≥ 100,000/µL

• Hemoglobin ≥ 9 g/dL

• Bilirubin < 1.5 times upper normal limit (ULN)

• AST and ALT ≤ 5 times UNL

• Alkaline phosphatase ≤ 5 times ULN

• Serum creatinine < 2 times ULN

• PT/INR/PTT < 1.5 times UNL

• Amylase and lipase < 1.5 times ULN

• Negative pregnancy test

• Fertile patients must use effective contraception

• Body mass index 18.5-30 kg/m^2 (WHO normal range: 18.5-25 kg/m^2)

• Able to swallow oral compound

• No criterion for unresectability or medical condition that contraindicates surgical resection

• No serious concurrent systemic disorder incompatible with the study, including any of the following:

• Uncontrolled hypertension (i.e., BP > 150/100 mm Hg despite optimal therapy)

• Active uncontrolled infection

• Active alcoholism

• No prior medical disorder, including any of the following:

• Cardiac arrhythmias requiring anti-arrhythmics (excluding beta-blockers or digoxin for chronic atrial fibrillation)

• Active coronary artery disease or ischemia

• Myocardial infarction within the past 6 months

• NYHA class III-IV congestive heart failure

• Pulmonary embolism within the past 6 months

• Gastrointestinal bleeding within the past 6 months

• No other prior malignancy within the past 5 years, except basal cell or squamous cell skin carcinoma or cured in situ cervical carcinoma

• No history or concurrent seizure disorder requiring medications (e.g., antiepileptic drugs)

• No history of HIV infection, or chronic hepatitis B or C

• No active clinically serious bacterial or fungal infection (i.e., grade 2 CTCAE v. 3)

• No condition that is unstable or could jeopardize the safety of the patient and his/her compliance with the study

• No substance abuse or medical, psychological, or social condition that could interfere with adherence to the study

• No known or suspected allergy to the investigational agent or to any agent given concurrently

• No presence of asthenia or rash > CTC grade 1 at enrollment

• Must be registered in a national health-care system

PRIOR CONCURRENT THERAPY:

• No prior orthotopic liver transplantation

• Not a candidate for orthotopic liver transplantation

• No prior systemic or loco-regional treatment for HCC

• No prior organ allograft

• No treatment with any other investigational medicinal product within the past 28 days

• No concurrent treatment with full-dose anticoagulants

• Deep-vein or catheter-associated thrombosis prophylaxis allowed

• Warfarin or heparin therapy allowed if the coagulation parameters were within the acceptable ranges prior to initiation of anticoagulant therapy

• No concurrent or chronic co-administration of CYP3A4 inducers (e.g., rifampin, Hypericum perforatum, phenytoin, carbamazepine, phenobarbital, or dexamethasone)