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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B Southwest Oncology Group North Central Cancer Treatment Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305877 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Biological: bevacizumab Biological: cetuximab Drug: capecitabine Drug: gemcitabine hydrochloride Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
Estimated Enrollment: | 126 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
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Biological: cetuximab
Given IV
Drug: capecitabine
Given orally
Drug: gemcitabine hydrochloride
Given IV
Radiation: radiation therapy
Given 5 days a week for 5½ weeks
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Arm II: Experimental
Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
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Biological: bevacizumab
Given IV
Drug: capecitabine
Given orally
Drug: gemcitabine hydrochloride
Given IV
Radiation: radiation therapy
Given 5 days a week for 5½ weeks
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Underwent prior surgical resection of all gross disease more than 4 but no more than 8 weeks ago
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Jordan D. Berlin, MD | Vanderbilt-Ingram Cancer Center |
Study Chair: | Arthur William Blackstock, MD | Wake Forest University |
Study Chair: | Andrew M. Lowy, MD | University of California, San Diego |
Study Chair: | Robert McWilliams, MD | Mayo Clinic |
Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
Study ID Numbers: | CDR0000462441, ECOG-E2204, CALGB-ECOG-E2204, SWOG-ECOG-E2204, NCCTG-ECOG-E2204 |
Study First Received: | March 21, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00305877 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage I pancreatic cancer stage II pancreatic cancer duct cell adenocarcinoma of the pancreas |
Antimetabolites Capecitabine Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Cetuximab Endocrine System Diseases Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents |
Pancrelipase Carcinoma Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Bevacizumab Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Gemcitabine Endocrine Gland Neoplasms |
Capecitabine Digestive System Neoplasms Growth Substances Cetuximab Endocrine System Diseases Enzyme Inhibitors Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |