Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer

Exclusion Criteria

• •Ampulla of Vater tumors
• •Any of the following as this regimen may be harmful to a developing fetus or nursing child:
• •* Pregnant women
• •* Breastfeeding women
• •* Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.)
• •* NOTE: The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown
• •Any of the following:
• •* \> 1 prior systemic anticancer therapy; Note: Chemoembolization will be considered as one prior chemotherapeutic regimen.
• •* Prior EGFR targeting therapy
• •* Nitrosoureas or mitomycin C ≤6 weeks prior to study entry
• •* Other chemotherapy ≤4 weeks prior to study entry
• •• Immunotherapy ≤ 4 weeks prior to study entry
• •* Biologic therapy ≤ 4 weeks prior to study entry
• •* Radiation therapy ≤ 4 weeks prior to study entry
• •* Prior cryotherapy, radiofrequency ablation, ethanol injection or photodynamic therapy ≤6 weeks prior to study entry
• •* Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
• •* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
• •* Major surgery, or significant traumatic injury occurring ≤ 3 weeks prior to planned treatment start date
• •Any of the following:
• •* Gastrointestinal tract disease resulting in an inability to take oral medication
• •* Requirement for IV alimentation
• •* Prior procedures affecting absorption
• •* Active peptic ulcer disease
• •History of other malignancy other than hepatocellular or biliary carcinoma within the previous 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix
• •Known abnormalities of the cornea such as:
• •* History of dry eye syndrome or Sjorgen's syndrome
• •* Congenital abnormality (e.g., Fuch's dystrophy)
• •* Abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose)
• •* Abnormal corneal sensitivity test (Schirmer test or similar tear production test)
• •Known CNS metastases; NOTE: These patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• •Uncontrolled intercurrent illness including, but not limited to:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris, cardiac arrhythmia
• •* Psychiatric illness/social situations that would limit compliance with study requirements
• •HIV-positive patients receiving combination anti-retroviral therapy; NOTE: Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; these patients are excluded from the study because of possible pharmacokinetic interactions with OSI-774; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated