Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00599833|
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: cetuximab Radiation: 3-dimensional conformal radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Masking:||None (Open Label)|
|Official Title:||Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2010|
- Progression-free survival rate at 6 months
- Response rate by RECIST criteria
- Toxicity by NCI CTCAE criteria
- Clinical benefit response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599833
|Leeds, England, United Kingdom, LS16 6QB|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Pat Price, MD||The Christie NHS Foundation Trust|