• Antitumor activity [ Designated as safety issue: No ]
• E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response [ Designated as safety issue: No ]

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and oxaliplatin together with erlotinib hydrochloride may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with gemcitabine hydrochloride and oxaliplatin in treating patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.

OBJECTIVES:

Primary

• To determine the maximum tolerated dose and the recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin in patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.

Secondary

• To describe any antitumor activity associated with this treatment regimen when given during the dose-escalation and expanded-cohort portions of this study.
• To evaluate e-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and assess their relationship to response.

OUTLINE: This is a multicenter, dose-escalation study of erlotinib hydrochloride.

Patients receive gemcitabine hydrochloride IV on day 1, oxaliplatin IV over 2 hours on day 2, and oral erlotinib hydrochloride once daily on days 3-8. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected for biomarker and other analysis.

After completion of study treatment, patients are followed up for 30 days.

• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Liver Cancer
• Pancreatic Cancer
• Periampullary Adenocarcinoma
• Small Intestine Cancer

• Drug: erlotinib hydrochloride
• Drug: gemcitabine hydrochloride
• Drug: oxaliplatin
• Other: laboratory biomarker analysis

DISEASE CHARACTERISTICS:

• Biopsy-confirmed diagnosis of one of the following:

  • Biliary tract adenocarcinoma
  • Pancreatic cancer
  • Duodenal cancer
  • Ampullary cancer (cytology acceptable)
• Advanced disease
• Measurable tumor by imaging examination
• No CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• ANC > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Bilirubin < 2.5 times normal
• Serum creatinine < 1.5 times normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection

• No other prior malignancy except for any of the following:

  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Adequately treated stage I or II cancer for which the patient is currently in complete remission
  • Any other cancer for which the patient has been disease-free for 5 years
• No psychiatric illness that would prevent understanding the nature of the investigational therapy and complying with study requirements
• No concurrent medical condition that, in the judgement of the investigator, would make the patient an inappropriate candidate for study enrollment

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or EGF receptor inhibitor therapy