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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
N/A
Not Enrolling
Both
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
study

- Patients who are taking Coumadin

Other protocol-defined inclusion / exclusion criteria may apply

Type of Study:

Interventional

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:

No

Principal Investigator

Novartis / Schering AG, Germany

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis / Schering AG, Germany

Authority:

United States: Food and Drug Administration

Study ID:

CPTK787 0135/306241

NCT ID:

NCT00056459

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

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
UCLA School of MedicineLos Angeles, California  900121973
Roswell Park Cancer InstituteBuffalo, New York  14263
George Washington University Medical CenterWashington, District of Columbia  20037
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Washington University School of MedicineSaint Louis, Missouri  63110
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
North Shore University HospitalManhasset, New York  11030
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Cooper Cancer InstituteCamden, New Jersey  08103
Southwest Regional Cancer CenterAustin, Texas  78705
Northeast Arkansas ClinicJonesboro, Arkansas  72401-3125
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Florida Cancer SpecialistsFort Myers, Florida  33901
Louisiana Oncology AssociatesLafayette, Louisiana  70506
Nevada Cancer CenterLas Vegas, Nevada  89109
Oncology ConsultantsHouston, Texas  77024
Danville Hematology and Oncology, Inc.Danville, Virginia  24541
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Pacific Shores Medical GroupLong Beach, California  90813
Norton Healthcare PavilionLouisville, Kentucky  40202
Highlands Oncology GroupSpringdale, Arkansas  72764
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Monroe Medical AssociatesChicago, Illinois  60603
Florida Oncology AssociatesOrange Park, Florida  32073
Northern Virginia Oncology GroupFairfax, Virginia  22031
Saint Louis UniversitySt. Louis, Missouri  63104
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Oncology Care Associates, PLLCSaint Joseph, Michigan  49085
Cancer Care AssociatesTulsa, Oklahoma  74136
Cascade Cancer CenterKirkland, Washington  98034-3013
Baptist Regional Cancer CenterKnoxville, Tennessee  37920
Corpus Christi Cancer CenterCorpus Christi, Texas  78412
Lakeland Regional Cancer CenterLakeland, Florida  33805
Charleston Cancer CenterCharleston, South Carolina  29406
Innovative Medical Research of South FloridaMiami Shores, Florida  33138
M.D. Anderson Cancer CenterHouston, Texas  77030
Metro Minnesota CCOPSt. Louis Park, Minnesota  55416
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Midwest Cancer Research GroupSkokie, Illinois  60077
Oncology Hematology Group of South FloridaMiami, Florida  33176
Kansas City Oncology and Hematology GroupKansas City, Missouri  64111
Providence St. Joseph Medical CenterBurbank, California  91505
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Charleston Hematology OncologyCharleston, South Carolina  29403
Hematology Oncology Consultants, Inc.Columbus, Ohio  43235
Virginia Cancer InstituteRichmond, Virginia  23230
California Oncology of the Central ValleyFresno, California  93710
Virginia K. Crosson Cancer CenterFullerton, California  92835
Wilshire Oncology Medical GroupGlendora, California  91741
North Valley Hematology/Oncology Medical GroupNorthridge, California  91328
Ventura County Hematology-Oncology SpecialistsOxnard, California  93030
Sansum Santa Barbara Foundation Medical ClinicSanta 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 GroupVista, California  92083
Maine Center for Cancer Medicine & Blood DisordersScarborough, Maine  04074
Cancer Institute Medical GroupLos Angeles, California  90025
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Josephine Ford Cancer CenterDetroit, Michigan  48202
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Western Washington Medical GroupEverett, Washington  98201
New York Oncology HematologyAlbany, New York  12208
Synergy Hematology-Oncology Medical AssociatesLos Angeles, California  90036
Eddie Hong-Lung Hu, M.D.Monterey Park, California  91754
Sierra View District HospitalPorterville, California  93257
Santa Clara Valley Medical CenterSan Jose, California  95128
Coastal Hematology & OncologySavannah, Georgia  31406
Oncology Hematology Associates of Central Illinois, PCPeoria, Illinois  61602
Northshore Cancer Research AssociationSkokie, Illinois  60076
LSU Medical CenterNew Orleans, Louisiana  70112
LSU Health Sciences CenterShreveport, Louisiana  71130-3932
Kaiser PermanenteRockville, Maryland  20850
Spectrum Health -- Cook Research Dept.Grand Rapids, Michigan  49503
Providence Cancer CenterSouthfield, Michigan  48075
Minnesota CGOPMinneapolis, Minnesota  55407
Missouri Cancer Care, PCSt. Charles, Missouri  63301
Arch Medical Services IncorporatedSt. Louis, Missouri  63141
North Central Montana Professional BuildingGreat Falls, Montana  59405
St. Barnabas Cancer CenterLivingston, New Jersey  07039
Pluta Cancer CenterRochester, New York  14623
Nashat Gabrail, M.D.Canton, Ohio  44718
Cancer Center of the CarolinasGreenville, South Carolina  29615
The Jones ClinicGermantown, Tennessee  38138
Scott & White HospitalTemple, Texas  76508
Southwestern Vermont Health CareBennington, Vermont  05201
Alabama Hematology/OncologyBirmingham, Alabama  35243
Palo Verde Hematology & OncologyGlendale, Arizona  85304
Compassionate Cancer Care Medical Group, IncFountain Valley, California  92708
Ronald Yanagiharaa, M.D.Gilroy, California  95020
Glendale Adventist Medical Center Cancer CenterGlendale, California  91206
USC/Norris Comprehensive Cancer Care CenterLos Angeles, California  90033
The Lucy Curci Cancer CenterRancho Mirage, California  92270
Colorado Cancer Research ProgramDenver, Colorado  80224
Jennifer Caskey, M.D.Wheat Ridge, Colorado  08833
Davis, Posteraro and Wasser, MD's, LLPManchester, Connecticut  06040
Connecticut Oncology GroupMiddletown, Connecticut  06457
Medical Oncology Hematology ConsultantsNewark, Delaware  19808
Washington Oncology-Hematology CenterWashington, District of Columbia  20016
Boca Raton Comprehensive Cancer CenterBoca Raton, Florida  33486
Memorial Healthcare SystemHollywood, Florida  33021
Hematology Oncology Associates of TreasurePort St. Lucie, Florida  34952
Florida Medical Clinic, PAZephyrhills, Florida  33542
Peachtree Hematology and OncologyAtlanta, Georgia  40202
Shelby D. Rifkin, M.D.Arlington Heights, Illinois  60004
Hematology-Oncology of Indiana, PCIndianapolis, Indiana  46260
Associated Physicians & Surgeons Clinic, L.L.C.Terre Haute, Indiana  47804
Markey Clinical Oncology Research ProgramLexington, Kentucky  40536-0098
Vijay Raghavan, M.D.Louisville, Kentucky  40215
St. Agnes Healthcare, Inc.Baltimore, Maryland  21229-5299
Hematology and Oncology Assoc. of Southern MississippiJackson, Michigan  48201
SMDC Health SystemDuluth, Minnesota  55805
Heartland Hematology/Oncology Associates, Inc.Kansas City, Missouri  64118
The Methodist Cancer CenterOmaha, Nebraska  68114
Hematology-Oncology Associates of New JerseyMorristown, New Jersey  07960
Southern Oncology and Hematology AssociatesVineland, New Jersey  08360
New Mexico Cancer CareSanta Fe, New Mexico  87505
CR Wood Cancer CenterGlen Falls, New York  12801
Cancer Research of Long IslandGreat Neck, New York  11023
Broome OncologyJohnson City, New York  13790
Cancer Center at Nyack HospitalNyack, New York  10960
Carolina Medical CenterCharlotte, North Carolina  28203
Mid-Dakota Clinic PCBismarck, North Dakota  58501
Mid Ohio Oncology/Hematology, Inc.Columbus, Ohio  43213
Meridia Cancer InstituteMayfield Heights, Ohio  44124
Kaiser Permanente Oncology HematologyPortland, Oregon  97227
Hershey Medical CenterHershey, Pennsylvania  17033
Monogahela Valley HospitalMonogahela, Pennsylvania  15063
University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104
Allegheny Cancer CenterPittsburgh, Pennsylvania  15212-4772
Center for Oncology Research & Treatment, PADallas, Texas  75230
H. Alejandro Preti, MD, PAHouston, Texas  77030
Dr. Lee C. DrinkardIrving, Texas  75038
North Utah AssociatesOgden, Utah  84403-3105
Cancer Treatment Centers of AmericaPortsmouth, Virginia  23704
UW Health -- University of Wisconsin CompMadison, Wisconsin  53792