Pancreatic Cancer Clinical Trial
Official title:
Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)
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. Radiation therapy uses high energy
x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of
radiation directly to the tumor may kill more tumor cells and cause less damage to normal
tissue. Giving cetuximab together with 3-dimensional conformal radiation therapy may kill
more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation
therapy works 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.
;
Masking: Open Label, Primary Purpose: Treatment
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