Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: panitumumab; capecitabine; fluorouracil; gemcitabine hydrochloride; radiation therapy
Intervention MeSH terms: Gemcitabine; Capecitabine; Fluorouracil; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as panitumumab, 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
      fluorouracil, capecitabine, and gemcitabine, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing. External-beam
      radiation therapy uses high-energy x-rays to kill tumor cells. Panitumumab may also stop the
      growth of pancreatic cancer by blocking blood flow to the tumor and make tumor cells more
      sensitive to radiation therapy. Giving panitumumab together with chemotherapy and radiation
      therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving panitumumab together with
      chemotherapy and external-beam radiation therapy works in treating patients with locally
      advanced pancreatic cancer that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed unresectable adenocarcinoma of the pancreas

               -  Including subtotal resection and gross residual disease

                    -  No microscopic residual disease only

          -  Measurable disease is not required

          -  Disease is encompassable within standard radiotherapy fields for pancreatic cancer

          -  No evidence of metastatic disease outside of the planned radiotherapy field

          -  No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin

          -  No distant metastases (i.e., liver or lung metastases or peritoneal spread)

          -  No history or known presence of CNS metastases

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  ANC ≥ 1,500/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  Platelet count ≥ 100,000/mm³

          -  Total bilirubin ≤ 3 times upper limit of normal (ULN)* NOTE: *Biliary stent placement
             or surgical bypass should be considered prior to treatment if impending bile duct
             obstruction by tumor

          -  AST ≤ 3 times ULN

          -  Creatinine ≤ 2.0 times ULN

          -  Magnesium normal

          -  Willing to return to an North Central Cancer Treatment Group (NCCTG) institution for
             follow-up

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 6 months
             after treatment with panitumumab

          -  No prior or concurrent malignancy unless disease-free ≥ 3 years except for
             non-melanoma skin cancer, carcinoma in situ of the cervix, or organ confined prostate
             cancer with Gleason score < 7

          -  No nausea or vomiting > grade 1

          -  No uncontrolled intercurrent illness including, but not limited to, any the following:

               -  Ongoing or active infection

               -  Psychiatric illness or social situations that would limit compliance with study
                  requirements

          -  No New York Heart Association clinically significant cardiovascular disease ≥ grade 2,
             including any of the following within the past year:

               -  Myocardial infarction

               -  Unstable angina

               -  Symptomatic congestive heart failure

               -  Serious, uncontrolled cardiac arrhythmia

          -  No known HIV positivity

          -  No known hepatitis C virus or acute or chronic active hepatitis B infection

          -  Adequate oral nutrition

        PRIOR CONCURRENT THERAPY:

          -  More than 21 days since prior laparotomy

          -  No prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g.,
             cetuximab)

          -  No prior small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, or lapatinib)

          -  No prior radiotherapy that would overlap with planned radiotherapy fields

          -  No prior or other concurrent chemotherapy

          -  No prior or other concurrent biologic therapy

          -  More than 4 weeks since prior and no concurrent or planned participation in another
             experimental drug study except studies with specific interventions intended to treat
             rashes associated with EGFR agents (e.g., N05C4)

          -  No concurrent enteral hyperalimentation

          -  No concurrent chronic immunosuppressive agents (e.g., methotrexate, cyclosporine, or
             corticosteroids)

          -  No concurrent colony-stimulating factors during the first course of therapy

          -  No other concurrent immunotherapy or radiotherapy