Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
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.
Radiation: 3-dimensional conformal radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)|
- Progression-free survival rate at 6 months [ Designated as safety issue: No ]
- Response rate by RECIST criteria [ Designated as safety issue: No ]
- Toxicity by NCI CTCAE criteria [ Designated as safety issue: Yes ]
- Clinical benefit response [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
- To evaluate the progression free survival rate in patients treated with cetuximab and radiotherapy.
- 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.
|Leeds, England, United Kingdom, LS16 6QB|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Pat Price, MD||Christie Hospital NHS Foundation Trust|