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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

Phase 3
18 Years
Not Enrolling
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Thank you

Trial Information

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

Inclusion Criteria

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

- Chronic kidney disease

- Acute or chronic liver disease

- Patients taking Coumadin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

throughout duration of study

Safety Issue:


Principal Investigator

Novartis/Schering AG, Germany

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis / Schering AG Germany


United States: Food and Drug Administration

Study ID:

CPTK787 0133/304946



Start Date:

January 2003

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Cancer
  • Oxaliplatin
  • VEGF inhibitor
  • Vatalanib
  • PTK787
  • Colon Cancer
  • Colorectal Carcinoma
  • Rectal Cancer
  • Colorectal Tumor
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Rectal Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624
UCLA School of Medicine Los Angeles, California  900121973
Roswell Park Cancer Institute Buffalo, New York  14263
Washington University School of Medicine Saint Louis, Missouri  63110
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Harrington Cancer Center Amarillo, Texas  79106
Virginia Mason Medical Center Seattle, Washington  98111
Swedish Cancer Institute Seattle, Washington  98104
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
North Shore University Hospital Manhasset, New York  11030
Franklin Square Hospital Center Baltimore, Maryland  21237
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
James P. Wilmot Cancer Center Rochester, New York  14642
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Northeast Arkansas Clinic Jonesboro, Arkansas  72401-3125
North Idaho Cancer Center Coeur d'Alene, Idaho  83814
Virginia Oncology Associates Newport News, Virginia  23606
Comprehensive Cancer Institute Huntsville, Alabama  35801
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Rocky Mountain Cancer Center Denver, Colorado  80218
Hematology Oncology Associates Atlantis, Florida  33462
Florida Cancer Specialists Fort Myers, Florida  33901
Nevada Cancer Center Las Vegas, Nevada  89109
Oncology Consultants Houston, Texas  77024
Center for Cancer And Hematologic Disease Cherry Hill, New Jersey  08046
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Cancer Treatment Centers of America in Hampton Roads Portsmouth, Virginia  23704
Pacific Shores Medical Group Long Beach, California  90813
Fallon Clinic at Worcester Medical Center Worcester, Massachusetts  01608
Arizona Clinical Research Center Tucson, Arizona  85712
Highlands Oncology Group Springdale, Arkansas  72764
Atlanta Cancer Care Atlanta, Georgia  30342
St. Agnes Healthcare Baltimore, Maryland  21229
Owensboro Medical Health System Owensboro, Kentucky  42303
Saint Louis University St. Louis, Missouri  63104
Meharry Medical College Nashville, Tennessee  37208-3599
South Carolina Oncology Associates Columbia, South Carolina  29201
Oncology Care Associates, PLLC Saint Joseph, Michigan  49085
Medical Oncology Care Associates Orange, California  92668
Fountain Valley, California  92708
Queens Medical Associates, PC Fresh Meadows, New York  11365
Cascade Cancer Center Kirkland, Washington  98034-3013
Baptist Regional Cancer Center Knoxville, Tennessee  37920
Arkansas Cancer Research Center Little Rock, Arkansas  72205
Case Western Reserve University Cleveland, Ohio  44106
Rainier Oncology Puyallup, Washington  98372
Charleston Cancer Center Charleston, South Carolina  29406
M.D. Anderson Cancer Center Houston, Texas  77030
Columbus CCOP Columbus, Ohio  43206
Oklahoma Oncology, Inc. Tulsa, Oklahoma  74104
Sarah Cannon Cancer Center Nashville, Tennessee  37203
Midwest Cancer Research Group Skokie, Illinois  60077
The Cleveland Clinic Foundation Cleveland, Ohio  
Providence St. Joseph Medical Center Burbank, California  91505
California Oncology of the Central Valley Fresno, California  93710
Virginia K. Crosson Cancer Center Fullerton, California  92835
Wilshire Oncology Medical Group Glendora, California  91741
North Valley Hematology/Oncology Medical Group Northridge, California  91328
Ventura County Hematology-Oncology Specialists Oxnard, California  93030
Sansum Santa Barbara Foundation Medical Clinic Santa Barbara, California  93105
Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara, California  93105
Cancer Care Associates Medical Group, Inc. Torrance, California  90505
San Diego Cancer Center Medical Group Vista, California  92083
Maine Center for Cancer Medicine & Blood Disorders Scarborough, Maine  04074
Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131
Compassionate Cancer Care medical Group, Inc. Fountain Valley, California  92708
Tulane University Health Sciences Center New Orleans, Louisiana  70112
USC Norris Cancer Center Los Angeles, California  90033
Penn State Hershey Medical Center Hershey, Pennsylvania  17033
Center for Oncology Research & Treatment Dallas, Texas  75230
UPMC Cancer Pavillion Pittsburgh, Pennsylvania  15232
Alaska Oncology and Hematology Anchorage, Alaska  99508
Little Rock Hematology & Oncology Little Rock, Arkansas  72205
Glendale Adventist Medical Center Glendale, California  91206
Scripps Green Hospital La Jolla, California  92037
Synergy Hematology-Oncology Medical Associates Los Angeles, California  90036
Eddie Hong-Lung Hu, M.D. Monterey Park, California  91754
Sierra View District Hospital Porterville, California  93257
Santa Clara Valley Medical Center San Jose, California  95128
Mile High Oncology Denver, Colorado  80210
Manchester Hematology/Oncology Assoc. Manchester, Connecticut  06040
Washington Oncology/Hematology Center Washington, District of Columbia  20037
The Center for Hematology and Oncology Boca Raton, Florida  33486
Oncology/Hematology Group of South Florida Miami, Florida  33176
University of Miami School of Medicine Miami, Florida  33136
Hematology Oncology Associates of Treasure Coast Port St. Lucie, Florida  34952
Florida Medical Clinic Zephyrhills, Florida  33542
Coastal Hematology & Oncology Savannah, Georgia  31406
Office of Research Savannah, Georgia  31405
Lewis Hall Singletary Oncology Center Thomasville, Georgia  31792
University of Chicago medical Center, Hematology/Oncology Chicago, Illinois  60637
Oncology Hematology Associates of Central Illinois, PC Peoria, Illinois  61602
Northshore Cancer Research Association Skokie, Illinois  60076
Fort Wayne Medical Oncology & Hematology, Inc. Fort Wayne, Indiana  46815
Munster Community Hospital Munster, Indiana  46321
Cotton O'Neil Oncology Clinic Topeka, Kansas  66606
Vijay Raghaven, M.D. Louisville, Kentucky  40215
Cabrini Center for Cancer Care Alexandria, Louisiana  71301
LSU Medical Center New Orleans, Louisiana  70112
LSU Health Sciences Center Shreveport, Louisiana  71130-3932
Kaiser Permanente Rockville, Maryland  20850
Spectrum Health -- Cook Research Dept. Grand Rapids, Michigan  49503
Providence Cancer Center Southfield, Michigan  48075
Minnesota CGOP Minneapolis, Minnesota  55407
Heartland Hematology Kansas City, Missouri  64118
Missouri Cancer Care, PC St. Charles, Missouri  63301
Arch Medical Services Incorporated St. Louis, Missouri  63141
North Central Montana Professional Building Great Falls, Montana  59405
NH Oncology-Hematology, PA Hooksett, New Hampshire  03106
St. Barnabas Cancer Center Livingston, New Jersey  07039
Hematology Oncology Associates of Northern New Jersey Morristown, New Jersey  07960
Cooper Cancer Center Voorhees, New Jersey  08043
New Mexico Oncology/Hematology Albuquerque, New Mexico  87109
Hematology/Oncology Associates Albuquerque, New Mexico  87102
Hematology/Oncology Associates of Central NY East Syracuse, New York  13057
Charles R. Wood Cancer Center Glens Falls, New York  12801
St. Vincent's Catholic Medical Centers of New York New York, New York  10011
Hematology-Oncology Associates of Rockland Nyack, New York  10956
Pluta Cancer Center Rochester, New York  14623
Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599-7305
Carolinas Hematology/Oncology Associates Charlotte, North Carolina  28203
Nashat Gabrail, M.D. Canton, Ohio  44718
The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Consultants in Medical Oncology & Hematology Drexel Hill, Pennsylvania  19026
Hematology & Oncology Associates of NE PA Dunmore, Pennsylvania  18512
Monongahela Valley Hospital Monongahela, Pennsylvania  15063
WJB Dom VAMC Columbia, South Carolina  29209
Cancer Center of the Carolinas Greenville, South Carolina  29615
Erlanger Health System Chattanooga, Tennessee  37403
Clarksville Regional Hematology/Oncology Clarksville, Tennessee  37043
The Jones Clinic Germantown, Tennessee  38138
Vanderbilt University School of Medicine Nashville, Tennessee  37232-6307
Clinical Hematology & Oncology Dallas, Texas  75235
H. Alejandro Preti, M.D., PA Houston, Texas  77030
South Texas Oncology & Hematology San Antonio, Texas  78207
Scott & White Hospital Temple, Texas  76508
Northern Utah Cancer Associates Ogden, Utah  84403
Southwestern Vermont Health Care Bennington, Vermont  05201
Western Washington Clinic Everett, Washington  98201
West Virginia University Health Sciences Center Morgantown, West Virginia  26506
Kettle Morain Oncology West Bend, Wisconsin  53095