Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction
Completed · Phase 1
Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
In brief
Phase I trial to study the effectiveness of erlotinib in treating patients who have unresectable liver cancer and liver dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
Key facts
- Study ID
- NCT00047346
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- 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 or cytologically confirmed unresectable hepatocellular carcinoma (HCC) with or without extrahepatic metastasis
- No fibrolamellar HCC
- No more than 2 prior therapies for HCC, including systemic chemotherapy, chemoembolization, hepatic arterial infusion of chemotherapeutic agents, and other novel agents
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Moderate hepatic dysfunction with any of the following:
- Bilirubin 2-4 g/dL
- Albumin < 2.5 g/dL
- Ascites
- PT 2-4 seconds > upper limit of normal (ULN)
- AST/ALT 2.6-10 times > ULN
- 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 ≥ 1,500/mm\^3
- Platelet count ≥ 60,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- No decompensated liver disease
- No jaundice
- No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius)
- No hyponatremia < 130 mEq/L
- No portal hypertension with bleeding esophageal or gastric varices within the past 3 months
- Creatinine ≤ 2 mg/dL
- No symptomatic congestive heart failure
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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