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A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

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

Thank you

Trial Information

A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

Inclusion Criteria

Inclusion criteria:

- Patients with metastatic colorectal cancer coming for initial chemotherapy

- Documented metastatic colorectal cancer

- 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 for metastatic colorectal cancer

- Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2
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 anti-VEGF agents

- Any prior therapy with oxaliplatin or allergy to platinum-containing drugs

- Peripheral neuropathy with functional impairment

- Female patients who are pregnant or breast feeding

- Any severe or uncontrolled medical conditions which could prevent participation in

- Patients who are taking Coumadin

Other protocol-defined inclusion / exclusion criteria may apply

Type of Study:


Study Design:

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

Outcome Measure:

Progression free 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 0135/306241



Start Date:

February 2003

Completion Date:

Related Keywords:

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



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University of Minnesota Cancer Center Minneapolis, Minnesota  55455
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Genesys Hurley Cancer Institute Flint, Michigan  48503
Waukesha Memorial Hospital Waukesha, Wisconsin  53188
North Shore University Hospital Manhasset, New York  11030
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Cooper Cancer Institute Camden, New Jersey  08103
Southwest Regional Cancer Center Austin, Texas  78705
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 Centers of Nevada Las Vegas, Nevada  89109
Florida Cancer Specialists Fort Myers, Florida  33901
Louisiana Oncology Associates Lafayette, Louisiana  70506
Nevada Cancer Center Las Vegas, Nevada  89109
Oncology Consultants Houston, Texas  77024
Danville Hematology and Oncology, Inc. Danville, Virginia  24541
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Pacific Shores Medical Group Long Beach, California  90813
Norton Healthcare Pavilion Louisville, Kentucky  40202
Highlands Oncology Group Springdale, Arkansas  72764
St. Joseph Mercy Hospital Pontiac, Michigan  48341-2985
Monroe Medical Associates Chicago, Illinois  60603
Florida Oncology Associates Orange Park, Florida  32073
Northern Virginia Oncology Group Fairfax, Virginia  22031
Saint Louis University St. Louis, Missouri  63104
South Carolina Oncology Associates Columbia, South Carolina  29201
Oncology Care Associates, PLLC Saint Joseph, Michigan  49085
Cancer Care Associates Tulsa, Oklahoma  74136
Cascade Cancer Center Kirkland, Washington  98034-3013
Baptist Regional Cancer Center Knoxville, Tennessee  37920
Corpus Christi Cancer Center Corpus Christi, Texas  78412
Lakeland Regional Cancer Center Lakeland, Florida  33805
Charleston Cancer Center Charleston, South Carolina  29406
Innovative Medical Research of South Florida Miami Shores, Florida  33138
M.D. Anderson Cancer Center Houston, Texas  77030
Metro Minnesota CCOP St. Louis Park, Minnesota  55416
The Center for Cancer and Hematologic Disease Cherry Hill, New Jersey  08003
Sarah Cannon Cancer Center Nashville, Tennessee  37203
Midwest Cancer Research Group Skokie, Illinois  60077
Oncology Hematology Group of South Florida Miami, Florida  33176
Kansas City Oncology and Hematology Group Kansas City, Missouri  64111
Providence St. Joseph Medical Center Burbank, California  91505
Pacific Hematology Oncology Associates San Francisco, California  94115
Charleston Hematology Oncology Charleston, South Carolina  29403
Hematology Oncology Consultants, Inc. Columbus, Ohio  43235
Virginia Cancer Institute Richmond, Virginia  23230
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
Cancer Institute Medical Group Los Angeles, California  90025
Utah Cancer Specialists Salt Lake City, Utah  84106
Tulane University Health Sciences Center New Orleans, Louisiana  70112
Josephine Ford Cancer Center Detroit, Michigan  48202
Montana Cancer Specialists Missoula, Montana  59807-7877
Western Washington Medical Group Everett, Washington  98201
New York Oncology Hematology Albany, New York  12208
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
Coastal Hematology & Oncology Savannah, Georgia  31406
Oncology Hematology Associates of Central Illinois, PC Peoria, Illinois  61602
Northshore Cancer Research Association Skokie, Illinois  60076
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
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
St. Barnabas Cancer Center Livingston, New Jersey  07039
Pluta Cancer Center Rochester, New York  14623
Nashat Gabrail, M.D. Canton, Ohio  44718
Cancer Center of the Carolinas Greenville, South Carolina  29615
The Jones Clinic Germantown, Tennessee  38138
Scott & White Hospital Temple, Texas  76508
Southwestern Vermont Health Care Bennington, Vermont  05201
Alabama Hematology/Oncology Birmingham, Alabama  35243
Palo Verde Hematology & Oncology Glendale, Arizona  85304
Compassionate Cancer Care Medical Group, Inc Fountain Valley, California  92708
Ronald Yanagiharaa, M.D. Gilroy, California  95020
Glendale Adventist Medical Center Cancer Center Glendale, California  91206
USC/Norris Comprehensive Cancer Care Center Los Angeles, California  90033
The Lucy Curci Cancer Center Rancho Mirage, California  92270
Colorado Cancer Research Program Denver, Colorado  80224
Jennifer Caskey, M.D. Wheat Ridge, Colorado  08833
Davis, Posteraro and Wasser, MD's, LLP Manchester, Connecticut  06040
Connecticut Oncology Group Middletown, Connecticut  06457
Medical Oncology Hematology Consultants Newark, Delaware  19808
Washington Oncology-Hematology Center Washington, District of Columbia  20016
Boca Raton Comprehensive Cancer Center Boca Raton, Florida  33486
Memorial Healthcare System Hollywood, Florida  33021
Hematology Oncology Associates of Treasure Port St. Lucie, Florida  34952
Florida Medical Clinic, PA Zephyrhills, Florida  33542
Peachtree Hematology and Oncology Atlanta, Georgia  40202
Shelby D. Rifkin, M.D. Arlington Heights, Illinois  60004
Hematology-Oncology of Indiana, PC Indianapolis, Indiana  46260
Associated Physicians & Surgeons Clinic, L.L.C. Terre Haute, Indiana  47804
Markey Clinical Oncology Research Program Lexington, Kentucky  40536-0098
Vijay Raghavan, M.D. Louisville, Kentucky  40215
St. Agnes Healthcare, Inc. Baltimore, Maryland  21229-5299
Hematology and Oncology Assoc. of Southern Mississippi Jackson, Michigan  48201
SMDC Health System Duluth, Minnesota  55805
Heartland Hematology/Oncology Associates, Inc. Kansas City, Missouri  64118
The Methodist Cancer Center Omaha, Nebraska  68114
Hematology-Oncology Associates of New Jersey Morristown, New Jersey  07960
Southern Oncology and Hematology Associates Vineland, New Jersey  08360
New Mexico Cancer Care Santa Fe, New Mexico  87505
CR Wood Cancer Center Glen Falls, New York  12801
Cancer Research of Long Island Great Neck, New York  11023
Broome Oncology Johnson City, New York  13790
Cancer Center at Nyack Hospital Nyack, New York  10960
Carolina Medical Center Charlotte, North Carolina  28203
Mid-Dakota Clinic PC Bismarck, North Dakota  58501
Mid Ohio Oncology/Hematology, Inc. Columbus, Ohio  43213
Meridia Cancer Institute Mayfield Heights, Ohio  44124
Kaiser Permanente Oncology Hematology Portland, Oregon  97227
Hershey Medical Center Hershey, Pennsylvania  17033
Monogahela Valley Hospital Monogahela, Pennsylvania  15063
University of Pennsylvania Abramson Cancer Center Philadelphia, Pennsylvania  19104
Allegheny Cancer Center Pittsburgh, Pennsylvania  15212-4772
Center for Oncology Research & Treatment, PA Dallas, Texas  75230
H. Alejandro Preti, MD, PA Houston, Texas  77030
Dr. Lee C. Drinkard Irving, Texas  75038
North Utah Associates Ogden, Utah  84403-3105
Cancer Treatment Centers of America Portsmouth, Virginia  23704
UW Health -- University of Wisconsin Comp Madison, Wisconsin  53792