Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed pancreatic cancer
• •Locally advanced or metastatic disease
• •No active CNS metastases
• •* Patients with stable CNS disease, who have undergone radiotherapy within the past 4 weeks and who have been on a stable dose of corticosteroids for \> 3 weeks, are eligible
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-1
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Bilirubin ≤ 1.5 mg/dL
• •Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) (5 times ULN if known hepatic metastases)
• •AST and ALT ≤ 3 times ULN (5 times ULN if known hepatic metastases)
• •Creatinine ≤ 1.5 mg/dL
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 90 days after completion of study treatment
• •No significant history of uncontrolled cardiac disease, including any of the following:
• •* Uncontrolled hypertension
• •* Unstable angina
• •* Myocardial infarction within the past 6 months
• •* Uncontrolled congestive heart failure
• •* Cardiomyopathy with decreased ejection fraction
• •No prior severe infusion reaction to a monoclonal antibody
• •No active infection or fever ≥ 38.5°C within the past 3 days
• •No known hypersensitivity to any components of gemcitabine hydrochloride, oxaliplatin, or to a monoclonal antibody
• •No peripheral neuropathy ≥ grade 2
• •No known HIV positivity
• •No hepatitis B or C infection (active, previously treated, or both)
• •No other medical condition, including mental illness or substance abuse, that would preclude study compliance
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Recovered from all prior therapy, including surgery
• •More than 30 days since prior investigational therapy
• •More than 4 weeks since prior radiotherapy
• •No prior radiotherapy to more than 25% of bone marrow
• •More than 30 days since prior chemotherapy
• •No prior chemotherapy for metastatic pancreatic cancer
• •Prior fluoropyrimidine as a radiosensitizer allowed
• •Prior gemcitabine hydrochloride in the adjuvant setting allowed
• •No prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway
• •No prior allogeneic transplantation
• •No other concurrent investigational therapy, chemotherapy, or systemic antineoplastic therapy
• •No other concurrent treatment that targets the EGFR
• •No other concurrent monoclonal antibody therapy
• •No concurrent radiotherapy except for local control of bone pain