Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

Stopped early · Phase 2

Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

In brief

Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Key facts

Study ID

NCT00047333

Run by

National Cancer Institute (NCI)

People needed

80

Starts

2002-08-01

Last updated by the study team

2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection
• No fibrolamellar HCC
• No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents
• The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study
• Surgery
• Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection)
• At least 1 unidimensionally measurable lesion
• At least 20 mm by conventional techniques
• Must have paraffin tissue block or unstained slides from biopsy or surgical specimen
• No known brain metastases
• No ascites that are refractory to conservative management (e.g., sodium restriction to 50 mEq/day dietary sodium and fluid restrictions and/or diuretics)
• Performance status - ECOG 0-2
• At least 16 weeks
• Granulocyte count at least 1,500/mm\^3
• Platelet count at least 60,000/mm\^3
• Hemoglobin at least 10 g/dL
• Bilirubin no greater than 1.8 mg/dL
• Albumin at least 2.5 g/dL
• AST/ALT no greater than 5 times upper limit of normal
• PT no greater than 1-3 seconds over normal
• No decompensated liver disease
• No jaundice
• No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius)
• No hyponatremia with sodium less than 125 mEq/L
• No portal hypertension with bleeding esophageal or gastric varices within the past 3 months

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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