PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the pancreas (head, body, or tail) or periampullary region, meeting both of the following criteria:

  • Unresectable disease
  • Locally advanced disease
• Measurable or evaluable disease by CT scan or MRI
• No evidence of metastatic disease outside of the planned irradiation field
• ECOG performance status 0-2
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.5 g/dL
• AST and ALT ≤ 5 times upper limit of normal
• Bilirubin ≤ 2.0 mg/dL
• Creatinine ≤ 2.0 mg/dL
• No clinical indication of compromised function of nonirradiated kidney
• No secondary malignancies within the past 5 years except for resected nonmelanoma skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion Criteria:

• No acute hepatitis
• No known HIV infection
• No other active or uncontrolled infection

• No significant history of uncontrolled cardiac disease, including any of the following:

  • Hypertension
  • Unstable angina
  • Myocardial infarction within the past 6 months
  • Congestive heart failure
  • Cardiomyopathy with decreased ejection fraction
• No prior severe infusion reaction to a monoclonal antibody

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to planned field of treatment
• No prior therapy that specifically and directly targets EGFR pathway
• At least 14 days since prior surgery or biopsy
• At least 28 days since prior bypass procedures
• More than 5 years since prior and no other concurrent chemotherapy
• No other concurrent investigational agent