Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

OBJECTIVES:

Primary

• Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.

Secondary

• Analyze the limiting toxicities according to CTC.
• Analyze the toxicity according to CTC.
• Determine the recommended dose.
• Determine the pharmacokinetic dosages of the three drugs.
• Analyze interactions between the drugs.

OUTLINE: This is a multicenter study.

Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Advanced disease
• No standard curative therapy available
• Must have received prior first-line chemotherapy
• No brain metastasis

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Life expectancy ≥ 8 weeks
• ANC ≥ 1.5 x 10^9/ L
• Platelet count ≥ 130 x 10^9/ L
• Hemoglobin ≥ 10 g/dL
• Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
• Bilirubin ≤ 1.5 times ULN
• Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No intolerance or hypersensitivity to any of the drugs being tested
• No history of interstitial lung disease
• No history of severe cardiac disease
• No serious uncontrolled infection
• No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
• Must not be deprived of liberty or under guardianship
• Must not be on probation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior erlotinib hydrochloride
• No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
• More than 14 days since participation in another clinical trial