Conditions: Hepatocellular Carcinoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

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

Arms:
arm 1: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28

Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 arm 2: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28

Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Interventions: intervention 1: Erlotinib intervention 2: Docetaxel
Intervention descriptions: intervention 1: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 intervention 2: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Protocol document: