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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091026 |
RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: bevacizumab Drug: cetuximab Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer |
Estimated Enrollment: | 126 |
Study Start Date: | September 2004 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15
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Drug: bevacizumab
Given IV
Drug: cetuximab
Given IV
Drug: gemcitabine hydrochloride
Given IV
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Arm II: Experimental
Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
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Drug: bevacizumab
Given IV
Drug: erlotinib hydrochloride
Given orally
Drug: gemcitabine hydrochloride
Given IV
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OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center (University of Chicago vs other) and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 54-126 patients (27-63 per treatment arm) will be accrued for this study within 16 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Advanced disease
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following arterial thromboembolic events within the past 6 months:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
At least 4 weeks since prior radiotherapy
Surgery
Other
Concurrent warfarin or low molecular weight heparin allowed provided the following criteria are met:
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Evanston Northwestern Healthcare - Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | |
Peoria, Illinois, United States, 61615-7828 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Michigan | |
Oncology Care Associates, PLLC | |
Saint Joseph, Michigan, United States, 49085 | |
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
New York, New York, United States, 10032 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 | |
NYU Cancer Institute at New York University Medical Center | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | Hedy L. Kindler, MD | University of Chicago |
Study ID Numbers: | CDR0000383145, UCCRC-13200A, NCI-6580 |
Study First Received: | September 7, 2004 |
Last Updated: | December 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00091026 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
Erlotinib Digestive System Neoplasms Pancreatic Neoplasms Cetuximab Endocrine System Diseases Bevacizumab Pancrelipase Recurrence |
Digestive System Diseases 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 Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |