Overview

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)