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Brief Title: Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas
Official Title: Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101
Study ID: NCT00532441
Brief Summary: An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be assessed in this trial.
Detailed Description: Outline: This is a multi-center study. Patients who meet eligibility criteria will receive treatment as follows until disease progression or excessive toxicities: * Erlotinib 150 mg p.o. daily on days 2-7, 9-14, 16-28 * Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8, 15 Treatment cycle = 28 days Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Life expectancy: At least 12 weeks Hematopoietic: * Absolute neutrophil count (ANC) \> 1000 mm3 * Platelet count \> 75,000 mm3 * Hemoglobin \> 8 g/dL Hepatic: * Bilirubin \< 2.0 x upper limit of normal (ULN) * Transaminases (AST, ALT) \< 5.0 x ULN if alkaline phosphatase is \< 2.5 x ULN, or alkaline phosphatase \< 5 x ULN if transaminases are \< 1.5 x ULN. * If not on anticoagulation: PT \< 4 seconds above ULN; INR \< 1.5; PTT \< 1.3 x ULN. * If on therapeutic anticoagulation, patients may have an INR \> 1.5 and PTT within therapeutic range; INR will be monitored weekly until stable. * Serum Albumin \> 3.0 Renal: * Creatinine clearance of \> 60 ml/ min (by Cockcroft-Gault) Pulmonary: * Not specified
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Helen F. Graham Cancer Center, Newark, Delaware, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois, United States
Cancer Care Center of Southern Indiana, Bloomington, Indiana, United States
Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
IN Onc/Hem Associates, Indianapolis, Indiana, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Quality Cancer Center (MCGOP), Indianapolis, Indiana, United States
Medical Consultants, P.C., Muncie, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Siteman Cancer Center, St. Louis, Missouri, United States
Methodist Cancer Center, Omaha, Nebraska, United States
Name: Elena Gabriela Chiorean, M.D.
Affiliation: Hoosier Oncology Group, LLC
Role: STUDY_CHAIR