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Tracking Information | |||||||||||||||||
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First Received Date † | March 21, 2006 | ||||||||||||||||
Last Updated Date | April 14, 2009 | ||||||||||||||||
Start Date † | February 2006 | ||||||||||||||||
Current Primary Outcome Measures † |
Toxicity [ Designated as safety issue: Yes ] | ||||||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||||||
Change History | Complete list of historical versions of study NCT00305877 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title † | Bevacizumab or Cetuximab Combined With Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery | ||||||||||||||||
Official Title † | An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma | ||||||||||||||||
Brief Summary | RATIONALE: Monoclonal antibodies, such as bevacizumab and 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer. PURPOSE: This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Tumor samples are analyzed for epidermal growth factor receptor (EGFR) status and microvessel density. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 126 patients will be accrued for this study. |
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Study Phase | Phase II | ||||||||||||||||
Study Type † | Interventional | ||||||||||||||||
Study Design † | Treatment, Randomized | ||||||||||||||||
Condition † | Pancreatic Cancer | ||||||||||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||||||
Enrollment † | 126 | ||||||||||||||||
Completion Date | |||||||||||||||||
Estimated Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts †† | |||||||||||||||||
Location Countries † | United States | ||||||||||||||||
Expanded Access Status | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT ID † | NCT00305877 | ||||||||||||||||
Responsible Party | Robert L. Comis, ECOG Group Chair's Office | ||||||||||||||||
Secondary IDs †† | ECOG-E2204, CALGB-ECOG-E2204, SWOG-ECOG-E2204, NCCTG-ECOG-E2204 | ||||||||||||||||
Study Sponsor † | Eastern Cooperative Oncology Group | ||||||||||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||
Verification Date | October 2008 | ||||||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |