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| Sponsored by: |
Christie Hospital NHS Foundation Trust |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00599833 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Biological: cetuximab Radiation: 3-dimensional conformal radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER) |
| Estimated Enrollment: | 44 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No history of prior malignancy that may interfere with the response evaluation except for any of the following:
PRIOR CONCURRENT THERAPY:
The following prior interventions are allowed:
Contacts and Locations| United Kingdom, England | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: Contact Person 44-161-446-8003 | |
| Cookridge Hospital | Recruiting |
| Leeds, England, United Kingdom, LS16 6QB | |
| Contact: Contact Person 44-113-392-4475 adrian.crellin@leedsth.nhs.uk | |
| Study Chair: | Pat Price, MD | Christie Hospital NHS Foundation Trust |
More Information
| Study ID Numbers: | CDR0000582420, CHNT-PACER, EUDRACT-2006-001742-13, EU-207103, CTA-21266/0210/001-0001 |
| Study First Received: | January 11, 2008 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00599833 History of Changes |
| Health Authority: | Unspecified |
|
adenocarcinoma of the pancreas stage III pancreatic cancer |
|
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Cetuximab Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Antineoplastic Agents Therapeutic Uses |
Pancreatic Neoplasms Cetuximab Endocrine System Diseases Pancreatic Diseases Pharmacologic Actions Endocrine Gland Neoplasms |