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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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
16 Weeks Progression-free Survival
To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.
Time frame: Start of treatment until disease progression per RECIST criteria up to 16 weeks
Response Rate
Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Time frame: 18 months
Overall Survival
Determine Overall Survival
Time frame: 18 Months
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