Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
ImClone LLC |
---|---|
Information provided by: | ImClone LLC |
ClinicalTrials.gov Identifier: | NCT00326911 |
Eligible patients with pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Biological: Cetuximab Biological: Bevacizumab Drug: Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas |
Enrollment: | 61 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
CBG: Active Comparator
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab,bevacizumab, and gemcitabine . On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
|
Biological: Cetuximab
An initial infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes)
Biological: Bevacizumab
10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.
Drug: Gemcitabine
1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.
|
CB: Active Comparator
Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
|
Biological: Cetuximab
An initial infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes)
Biological: Bevacizumab
10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If the patient is on full-dose anticoagulation therapy (eg, warfarin or low molecular weight [LMW] heparin), the following criteria must be met:
If the patient is not on full-dose anticoagulation therapy, the following criteria must be met:
Exclusion Criteria:
United States, Arizona | |
Clopton Clinic | |
Jonesboro, Arizona, United States, 72401 | |
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Connecticut | |
Hematology Oncology, PC | |
Stamford, Connecticut, United States, 06902 | |
United States, Florida | |
Hematology & Oncology Consultants | |
Orlando, Florida, United States, 32804 | |
M. D. Anderson Cancer Center Orlando | |
Orlando, Florida, United States, 32806 | |
Advanced Medical Specialties | |
Miami, Florida, United States, 33176 | |
United States, Georgia | |
Peachtree Hematology - Oncology Consultants, PC | |
Atlanta, Georgia, United States, 30309 | |
Augusta Oncology Associates, PC | |
Augusta, Georgia, United States, 30901 | |
Northwest Georgia Oncology Centers, PC | |
Marietta, Georgia, United States, 30060 | |
United States, Louisiana | |
Jayne Gurtler, MD, Laura Brinz, MD , & Angelo Russo, MD | |
Metairie, Louisiana, United States, 70006 | |
United States, Montana | |
Hematology, Oncology Centers of the Northern Rockies, PC | |
Billings, Montana, United States, 59101 | |
United States, North Carolina | |
NorthEast Oncology Associates | |
Concord, North Carolina, United States, 28025 | |
United States, Pennsylvania | |
Pennsylvania Oncology Hematology Associates | |
Philadelphia, Pennsylvania, United States, 19106 | |
United States, South Carolina | |
Charleston Cancer Center | |
Charleston, South Carolina, United States, 29406 | |
United States, Texas | |
Arlington Cancer Center | |
Arlington, Texas, United States, 76012 | |
Center for Oncology Research and Treatment, PA | |
Dallas, Texas, United States, 75230 |
Principal Investigator: | Andrew Ko, MD | University of California, San Francisco |
Responsible Party: | ImClone LLC ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP02-0555 |
Study First Received: | May 15, 2006 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00326911 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Cetuximab Endocrine System Diseases Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents |
Antiviral Agents Pancrelipase 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 Digestive System Neoplasms Growth Substances Cetuximab Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |