Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2003
End Date:January 2007

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A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum

The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus
vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer
that has spread to other organs and whose disease has worsened after treatment with
irinotecan.


Inclusion criteria

- Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease

- One prior chemotherapy regimen with irinotecan and 5FU

- Evidence of progressive disease within 6 months after last dose of irinotecan

- WHO Performance Status of 0, 1, or 2

- Measurable tumors

- Adequate hematologic status, liver and kidney function

- Life expectancy greater than 12 weeks

- Written informed consent obtained

Exclusion criteria

- History or presence of central nervous system disease

- Patients with a history of another primary cancer within 5 years

- Prior chemotherapy within 3 weeks before entry to study

- Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study

- Investigational drugs within 4 weeks before entry to study

- Prior therapy with oxaliplatin

- Peripheral neuropathy with functional impairment

- Female patients who are pregnant or breast feeding

- Any severe or uncontrolled medical condition which could prevent participation in
study

- Chronic kidney disease

- Acute or chronic liver disease

- Patients taking Coumadin
We found this trial at
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Baltimore, Maryland 21237
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Boca Raton, Florida 33486
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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3450 Lantana Road Lantana Road
Lake Worth, Florida 33461
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Albuquerque, New Mexico 87106
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Albuquerque, New Mexico 87109
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Alexandria, Louisiana 71301
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Amarillo, Texas 79106
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Anchorage, Alaska 99508
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Bakersfield, California 93309
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Baltimore, Maryland 21229
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Bennington, Vermont 05201
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Burbank, California 91505
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Canton, Ohio 44718
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28203
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Chattanooga, Tennessee 37403
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Cherry Hill, New Jersey 08003
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Clarksville, Tennessee 37043
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
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Coeur d'Alene, Idaho 83814
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Columbia, South Carolina 29209
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100 Michigan Street, NE, MC012
Columbus, Ohio 43215
(614) 488-2118
Columbus CCOP As one of the original 20 CCOPs, the Columbus Community Clinical Oncology Program...
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Dallas, Texas 75235
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Drexel Hill, Pennsylvania 19026
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East Syracuse, New York 13057
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Everett, Washington 98201
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Fountain Valley, California 92708
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Fresh Meadows, New York 11365
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Ft. Myers, Florida 33916
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Fullerton, California 92835
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Germantown, Tennessee 38138
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Glendale, California 91206
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Grand Rapids, Michigan 49503
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Great Falls, Montana 59405
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Greenville, South Carolina 29605
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Hershey, Pennsylvania 17033
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Hooksett, New Hampshire 03106
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Houston, Texas 77203
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Huntsville, Alabama 35801
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Jonesboro, Arkansas 72401
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Kansas City, Missouri 64118
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Kirkland, Washington 98034
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Knoxville, Tennessee 37920
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La Jolla, California 92037
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La Verne, California 91750
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Las Vegas, Nevada 89109
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Little Rock, Arkansas 72205
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Livingston, New Jersey 07039
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Louisville, Kentucky 40215
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Manchester, Connecticut 06040
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Marietta, Georgia 30060
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Munster, Indiana 46321
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Sarah Cannon Cancer Center People who live with cancer
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Nashville, Tennessee 37208
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Nashville, Tennessee 37232
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
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New Orleans, Louisiana 70112
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Northridge, California 91328
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Orange, California 92868
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Owensboro, Kentucky 42303
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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