Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

OBJECTIVES:

Primary

• To evaluate the progression free survival rate in patients treated with cetuximab and radiotherapy.

Secondary

• To determine the response rate, toxicity of the combined regimen, and clinical benefit response in patients treated with cetuximab and radiotherapy.

OUTLINE: Patients receive cetuximab IV over 1-2 hours once weekly for 6-7 weeks. Patients also undergo concurrent 3-dimensional image-guided conformal radiotherapy in 28-30 fractions over approximately 5.5-6 weeks (2-4 hours after administration of cetuximab).

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years.

DISEASE CHARACTERISTICS:

• Histopathologically or cytologically confirmed diagnosis of inoperable, non-metastatic, locally advanced pancreatic adenocarcinoma
• No neuroendocrine tumors or lymphoma of the pancreas
• No extensive disease unable to be covered in a radically treatable radiotherapy volume

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy > 3 months
• Hemoglobin ≥ 10g/dL
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³ (prior transfusions for patients with low hemoglobin allowed)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT and AST ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 1.5 times ULN
• Serum urea ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Adequate biliary drainage with no evidence of active uncontrolled infection (patients on prophylactic antibiotics are eligible)
• Not pregnant or nursing
• Negative pregnancy test
• Women and men of child-bearing potential should be using an adequate contraception method, which must be continued for 3 months after completion of therapy
• No unresolved biliary tract obstruction
• No history of prior malignancy that may interfere with the response evaluation except for any of the following:

• Cervical carcinoma in-situ treated by cone-biopsy/resection
• Nonmetastatic basal and/or squamous cell carcinomas of the skin
• Any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously
• No relative contraindication to radiotherapy
• No evidence of severe uncontrolled systemic diseases or laboratory finding that in the view of investigator makes it undesirable for the patient to participate in the trial
• No disorder likely to impact compliance with the protocol

PRIOR CONCURRENT THERAPY:

• Must be completely recovered from previous surgery
• The following prior interventions are allowed:

• Non-curative operation (i.e., R2 resection with macroscopic residual disease evident on CT scan or palliative bypass procedure)
• Stent insertion in the common bile duct
• No previous radiotherapy within current treatment field
• No previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted therapy