Status:
UNKNOWN
Sorafenib Tosylate in Treating Patients With Liver Cancer That Can Be Removed by Surgery
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 studyi...
Detailed Description
OBJECTIVES: Primary * To assess anti-tumor activity of neoadjuvant sorafenib tosylate in tumor samples from patients with resectable hepatocellular carcinoma (HCC). Secondary * To characterize pat...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01182272
Start Date
May 1 2010
Last Update
August 16 2010
Active Locations (1)
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1
Hopital Beaujon
Clichy, France, 92110