Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
NCT ID: NCT00460603
Last Updated: 2013-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
187 participants
INTERVENTIONAL
2006-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
bevacizumab 5 mg/kg every 2 weeks + FOLFOX
bevacizumab
bevacizumab 5 mg/kg every 2 weeks
C
AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX
AG-013726
AG-013726 5 mg bid every 2 weeks
A
AG-013736 5 mg bid starting dose + FOLFOX
AG-013736 (axitinib)
AG-013736 5 mg bid starting dose
Interventions
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bevacizumab
bevacizumab 5 mg/kg every 2 weeks
AG-013726
AG-013726 5 mg bid every 2 weeks
AG-013736 (axitinib)
AG-013736 5 mg bid starting dose
Eligibility Criteria
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Inclusion Criteria
* (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
* Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was \> 12 months prior to enrollment,
* Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.
Exclusion Criteria
* Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
* Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
* Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed \> 2 weeks of enrollment and be fully recovered from any procedure.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Daphne, Alabama, United States
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Huntsville, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Antioch, California, United States
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Colton, California, United States
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Corona, California, United States
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Gilroy, California, United States
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Glendora, California, United States
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La Jolla, California, United States
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La Jolla, California, United States
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Pasadena, California, United States
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Pleasant Hill, California, United States
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Pomona, California, United States
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Rancho Cucamonga, California, United States
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Rancho Mirage, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Leandro, California, United States
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West Covina, California, United States
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Auroa, Colorado, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Lone Tree, Colorado, United States
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Longmont, Colorado, United States
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Parker, Colorado, United States
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Thornton, Colorado, United States
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Ocala, Florida, United States
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Stuart, Florida, United States
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Atlanta, Georgia, United States
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Beech Grove, Indiana, United States
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Indianapolis, Indiana, United States
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Jeffersonville, Indiana, United States
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Muncie, Indiana, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Shelbyville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Brownstone, Michigan, United States
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Dearborn, Michigan, United States
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Detroit, Michigan, United States
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West Bloomfield, Michigan, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Lee's Summit, Missouri, United States
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St Louis, Missouri, United States
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Grand Island, Nebraska, United States
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Las Vegas, Nevada, United States
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Summit, New Jersey, United States
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Albany, New York, United States
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Albany, New York, United States
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Amsterdam, New York, United States
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Hudson, New York, United States
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Latham, New York, United States
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Rexford, New York, United States
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Troy, New York, United States
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Kernersville, North Carolina, United States
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Lexington, North Carolina, United States
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Mount Airy, North Carolina, United States
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North Wilkesboro, North Carolina, United States
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Pollocksville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Oregon City, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Tualatin, Oregon, United States
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West Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Easley, South Carolina, United States
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Greenville, South Carolina, United States
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Greenville, South Carolina, United States
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Seneca, South Carolina, United States
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Spartanburg, South Carolina, United States
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Chattanooga, Tennessee, United States
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Franklin, Tennessee, United States
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Gallatin, Tennessee, United States
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Hermitage, Tennessee, United States
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Lebanon, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Smyrna, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Ogden, Utah, United States
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Everett, Washington, United States
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Kennewick, Washington, United States
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Vancouver, Washington, United States
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Vancouver, Washington, United States
Countries
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References
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Hoh CK, Burris HA 3rd, Bendell JC, Tarazi J, Rosbrook B, Kim S, Infante JR, Reid TR. Intermittent dosing of axitinib combined with chemotherapy is supported by (18)FLT-PET in gastrointestinal tumours. Br J Cancer. 2014 Feb 18;110(4):875-81. doi: 10.1038/bjc.2013.806. Epub 2014 Jan 14.
Infante JR, Reid TR, Cohn AL, Edenfield WJ, Cescon TP, Hamm JT, Malik IA, Rado TA, McGee PJ, Richards DA, Tarazi J, Rosbrook B, Kim S, Cartwright TH. Axitinib and/or bevacizumab with modified FOLFOX-6 as first-line therapy for metastatic colorectal cancer: a randomized phase 2 study. Cancer. 2013 Jul 15;119(14):2555-63. doi: 10.1002/cncr.28112. Epub 2013 Apr 19.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4061020
Identifier Type: -
Identifier Source: org_study_id