Loading clinical trials...
Loading clinical trials...
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cookridge Hospital
Leeds, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Start Date
May 1, 2007
Primary Completion Date
September 1, 2010
Completion Date
October 1, 2010
Last Updated
June 26, 2013
44
ESTIMATED participants
cetuximab
BIOLOGICAL
3-dimensional conformal radiation therapy
RADIATION
Lead Sponsor
The Christie NHS Foundation Trust
NCT05053971
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions