A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer
All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously
(IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1
and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85
mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, followed by 2400 mg/m2 administered as a
continuous infusion over 46 hours via a pump (outpatient) and leucovorin 350 mg IV (modified
FOLFOX6). Cycles were 14 days.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
18 months
No
David R. Spigel, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Institutional Review Board
SCRI GI 64
NCT00193219
July 2005
July 2010
Name | Location |
---|---|
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Mercy Hospital | Portland, Maine 04101 |
Chattanooga Oncology and Hematology Associates | Chattanooga, Tennessee 37404 |
St. Louis Cancer Care | Chesterfield, Missouri 63017 |
Jackson Oncology Associates | Jackson, Mississippi 39202 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |