Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas

Inclusion Criteria

• •Histological or cytological proof of hepatocellular or biliary tract carcinomas, not amenable to curative resection or transplantation.
• •Prior cancer treatment completed at least 30 days prior to being registered for protocol therapy and recovered from the acute toxicity effects of the regimen.
• •Patients may have had radiofrequency ablation, cryosurgery or embolization, but must have documented progressive disease with the involved lesion, or at least one previously untreated lesion.
• •Patients may have had ≤ 2 prior chemotherapy regimens.
• •Prior radiation therapy allowed to \< 25% of the bone marrow at least 30 days prior to being registered for protocol therapy.
• •Patients with biliary obstruction must have percutaneous transhepatic drainage or endoscopic stent placement prior to starting study treatment.
• •Patients with a history of malignancy are eligible provided they have been curatively treated and demonstrate no evidence for recurrence of that cancer.
• •Peripheral neuropathy ≤ grade 1.
• •Patients must agree to abstain from frozen or fresh grapefruit or grapefruit juice for 5 days prior to, and during treatment.
• •Patients must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 12 week period thereafter.
• •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
• •Written informed consent and HIPAA authorization for release of personal health information.
• •Age ≥ 18 years at time of consent.