Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

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. Cetuximab may also stop the growth
      of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as
      gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either
      by killing the cells or by stopping them from dividing. Giving cetuximab together with
      combination chemotherapy may kill more tumor cells.

      PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine
      and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the progression-free survival of patients with locally advanced or metastatic
           pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin.

      Secondary

        -  Determine the complete response and partial response in patients treated with this
           regimen.

        -  Determine the time to progression in patients treated with this regimen.

        -  Determine the duration of response in patients treated with this regimen.

        -  Determine the survival of patients treated with this regimen.

        -  Determine the toxicity of this regimen in these patients.

      OUTLINE: This is a nonrandomized, open-label, pilot study.

      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 2-4 hours on day 2. Treatment repeats
      every 14 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): Cetuximab; Gemcitabine Hydrochloride; Oxaliplatin
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Cetuximab: an initial loading dose of 400 mg/m2 will be given followed by 250 mg/m2 administered weekly. Cetuximab will be given first followed by gemcitabine on the weeks the patient receives cytotoxic chemotherapy on day 1. Cetuximab will be given as a single agent on Day 8. The treatment will be given on two-week cycles.; Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.; Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.
Other intervention name(s): C-225; Gemcitabine HCl
Intervention MeSH terms: Gemcitabine; Oxaliplatin; Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer; stage II pancreatic cancer