Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: cetuximab; capecitabine; oxaliplatin; conventional surgery; radiation therapy; Gemcitabine
Intervention MeSH terms: Gemcitabine; Capecitabine; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when
      chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be
      resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug
      resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed. Radiation therapy uses high-energy x-rays to kill tumor cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin
      and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works
      in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be
      removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or radiologically confirmed pancreatic cancer, meeting both of the
             following criteria:

               -  Locally advanced, nonmetastatic disease

               -  Surgically unresectable disease

          -  Measurable disease, defined as unidimensionally measurable by physical exam or imaging
             study

               -  The following are considered nonmeasurable disease:

                    -  Bone-only disease

                    -  Pleural or peritoneal effusions

                    -  CNS lesions

                    -  Irradiated lesions in the absence of progression after radiotherapy

          -  No history or evidence of CNS disease

          -  No metastatic disease to distant organs (e.g., liver, lung, brain, or bone)

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 2.0 mg/dL

          -  Creatinine ≤ 2.0 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 90 days after
             completion of study therapy

          -  No acute hepatitis

          -  No known HIV positivity

          -  No active or uncontrolled infection

          -  No significant history of uncontrolled cardiac disease, including, but not limited to,
             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 second malignancy other than nonmelanoma skin cancer

          -  No history of deep vein thrombosis

          -  No history of bleeding diathesis or coagulopathy

          -  No other severe concurrent disease, mental incapacitation, or psychiatric illness that
             would preclude study participation

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for pancreatic cancer

          -  No prior therapy specifically targeting the epidermal growth factor-receptor pathway

          -  No major surgical procedure or open biopsy within the past 28 days

          -  No prior radiotherapy or chemotherapy

          -  No prior or concurrent full-dose anticoagulants or thrombolytics