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

NCT01182272 | Unknown Phase 2

• 4 other identifiers: CDR0000682840FRE-GERCOR-D09-1-BIOSHAREEUDRACT-2009-018058-44EU-21058
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 studying how well sorafenib tosylate works in treating patients with liver cancer that can be removed by surgery.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized resectable adult primary liver cancer

Outcome Measures

Primary Outcomes (2)

• Antiangiogenic effects of sorafenib tosylate

• Significant pathological changes

Secondary Outcomes (6)

• Pathologic findings in sorafenib tosylate pre-treated patients undergoing surgical resection for hepatocellular carcinoma

• Number of R0 resections

• Correlations between baseline patient characteristics, cancer biomarkers, and outcome variables and resected tumors

• Plasma biomarkers at baseline, day 28, and the day before surgery

• Safety profile of sorafenib tosylate

Interventions

sorafenib tosylate DRUG

laboratory biomarker analysis OTHER

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (1)

Hopital Beaujon

Clichy, 92110, France

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Sorafenib; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics

Study Officials

• Sandrine Faivre

  Hopital Beaujon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 16, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2012
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

FR (1)