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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the progression-free survival rate in patients with unresectable, locally
           advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy
           comprising cetuximab, gemcitabine hydrochloride, and oxaliplatin followed by either
           surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine.

      Secondary

        -  Determine the toxicity and tolerability of this regimen in these patients.

        -  Determine overall survival and progression-free survival.

        -  Determine the response rate in these patients.

        -  Determine the response duration (defined as the time from first observation response to
           the time of progressive disease) in patients who achieve at least a partial response to
           treatment.

        -  Determine the biomarker response of CA19-9.

      OUTLINE: This is an open-label study.

        -  Neoadjuvant therapy: Patients receive cetuximab IV over 1-2 hours on days 1 and 8,
           gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2 hours
           on day 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease
           progression or unacceptable toxicity.

      Patients are evaluated after completion of neoadjuvant therapy. Patients with metastatic
      disease are taken off study. Beginning within 4 weeks after completion of neoadjuvant
      therapy, patients with resectable disease proceed to surgical resection or chemoradiotherapy
      (by choice); patients with unresectable disease proceed to chemoradiotherapy.

        -  Surgery: Patients undergo surgical resection with the Whipple procedure.

        -  Chemoradiotherapy: Patients receive oral capecitabine twice daily 5 days a week (on days
           1-5) and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks.

      After completion of study treatment, patients are followed every 3 months for 1 year.

      PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
    

Intervention name(s): cetuximab; capecitabine; oxaliplatin; conventional surgery; radiation therapy; Gemcitabine
Intervention type(s): Biological; Drug; Drug; Procedure; Radiation; Drug
Intervention MeSH terms: Gemcitabine; Capecitabine; Oxaliplatin; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer