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

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, stage II pancreatic cancer Read More

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