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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
N/A
Not Enrolling
Both
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
study

- Chronic kidney disease

- Acute or chronic liver disease

- Patients taking Coumadin

Type of Study:

Interventional

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:

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 0133/304946

NCT ID:

NCT00056446

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

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
UCLA School of MedicineLos Angeles, California  900121973
Roswell Park Cancer InstituteBuffalo, New York  14263
Washington University School of MedicineSaint Louis, Missouri  63110
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Harrington Cancer CenterAmarillo, Texas  79106
Virginia Mason Medical CenterSeattle, Washington  98111
Swedish Cancer InstituteSeattle, Washington  98104
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
North Shore University HospitalManhasset, New York  11030
Franklin Square Hospital CenterBaltimore, Maryland  21237
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
James P. Wilmot Cancer CenterRochester, New York  14642
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Northeast Arkansas ClinicJonesboro, Arkansas  72401-3125
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer InstituteHuntsville, Alabama  35801
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Rocky Mountain Cancer CenterDenver, Colorado  80218
Hematology Oncology AssociatesAtlantis, Florida  33462
Florida Cancer SpecialistsFort Myers, Florida  33901
Nevada Cancer CenterLas Vegas, Nevada  89109
Oncology ConsultantsHouston, Texas  77024
Center for Cancer And Hematologic DiseaseCherry Hill, New Jersey  08046
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Cancer Treatment Centers of America in Hampton RoadsPortsmouth, Virginia  23704
Pacific Shores Medical GroupLong Beach, California  90813
Fallon Clinic at Worcester Medical CenterWorcester, Massachusetts  01608
Arizona Clinical Research CenterTucson, Arizona  85712
Highlands Oncology GroupSpringdale, Arkansas  72764
Atlanta Cancer CareAtlanta, Georgia  30342
St. Agnes HealthcareBaltimore, Maryland  21229
Owensboro Medical Health SystemOwensboro, Kentucky  42303
Saint Louis UniversitySt. Louis, Missouri  63104
Meharry Medical CollegeNashville, Tennessee  37208-3599
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Oncology Care Associates, PLLCSaint Joseph, Michigan  49085
Medical Oncology Care AssociatesOrange, California  92668
Fountain Valley, California  92708
Queens Medical Associates, PCFresh Meadows, New York  11365
Cascade Cancer CenterKirkland, Washington  98034-3013
Baptist Regional Cancer CenterKnoxville, Tennessee  37920
Arkansas Cancer Research CenterLittle Rock, Arkansas  72205
Case Western Reserve UniversityCleveland, Ohio  44106
Rainier OncologyPuyallup, Washington  98372
Charleston Cancer CenterCharleston, South Carolina  29406
M.D. Anderson Cancer CenterHouston, Texas  77030
Columbus CCOPColumbus, Ohio  43206
Oklahoma Oncology, Inc.Tulsa, Oklahoma  74104
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Midwest Cancer Research GroupSkokie, Illinois  60077
The Cleveland Clinic FoundationCleveland, Ohio  
Providence St. Joseph Medical CenterBurbank, California  91505
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
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
USC Norris Cancer CenterLos Angeles, California  90033
Penn State Hershey Medical CenterHershey, Pennsylvania  17033
Center for Oncology Research & TreatmentDallas, Texas  75230
UPMC Cancer PavillionPittsburgh, Pennsylvania  15232
Alaska Oncology and HematologyAnchorage, Alaska  99508
Little Rock Hematology & OncologyLittle Rock, Arkansas  72205
Glendale Adventist Medical CenterGlendale, California  91206
Scripps Green HospitalLa Jolla, California  92037
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
Mile High OncologyDenver, Colorado  80210
Manchester Hematology/Oncology Assoc.Manchester, Connecticut  06040
Washington Oncology/Hematology CenterWashington, District of Columbia  20037
The Center for Hematology and OncologyBoca Raton, Florida  33486
Oncology/Hematology Group of South FloridaMiami, Florida  33176
University of Miami School of MedicineMiami, Florida  33136
Hematology Oncology Associates of Treasure CoastPort St. Lucie, Florida  34952
Florida Medical ClinicZephyrhills, Florida  33542
Coastal Hematology & OncologySavannah, Georgia  31406
Office of ResearchSavannah, Georgia  31405
Lewis Hall Singletary Oncology CenterThomasville, Georgia  31792
University of Chicago medical Center, Hematology/OncologyChicago, Illinois  60637
Oncology Hematology Associates of Central Illinois, PCPeoria, Illinois  61602
Northshore Cancer Research AssociationSkokie, Illinois  60076
Fort Wayne Medical Oncology & Hematology, Inc.Fort Wayne, Indiana  46815
Munster Community HospitalMunster, Indiana  46321
Cotton O'Neil Oncology ClinicTopeka, Kansas  66606
Vijay Raghaven, M.D.Louisville, Kentucky  40215
Cabrini Center for Cancer CareAlexandria, Louisiana  71301
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
Heartland HematologyKansas City, Missouri  64118
Missouri Cancer Care, PCSt. Charles, Missouri  63301
Arch Medical Services IncorporatedSt. Louis, Missouri  63141
North Central Montana Professional BuildingGreat Falls, Montana  59405
NH Oncology-Hematology, PAHooksett, New Hampshire  03106
St. Barnabas Cancer CenterLivingston, New Jersey  07039
Hematology Oncology Associates of Northern New JerseyMorristown, New Jersey  07960
Cooper Cancer CenterVoorhees, New Jersey  08043
New Mexico Oncology/HematologyAlbuquerque, New Mexico  87109
Hematology/Oncology AssociatesAlbuquerque, New Mexico  87102
Hematology/Oncology Associates of Central NYEast Syracuse, New York  13057
Charles R. Wood Cancer CenterGlens Falls, New York  12801
St. Vincent's Catholic Medical Centers of New YorkNew York, New York  10011
Hematology-Oncology Associates of RocklandNyack, New York  10956
Pluta Cancer CenterRochester, New York  14623
Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599-7305
Carolinas Hematology/Oncology AssociatesCharlotte, North Carolina  28203
Nashat Gabrail, M.D.Canton, Ohio  44718
The University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Consultants in Medical Oncology & HematologyDrexel Hill, Pennsylvania  19026
Hematology & Oncology Associates of NE PADunmore, Pennsylvania  18512
Monongahela Valley HospitalMonongahela, Pennsylvania  15063
WJB Dom VAMCColumbia, South Carolina  29209
Cancer Center of the CarolinasGreenville, South Carolina  29615
Erlanger Health SystemChattanooga, Tennessee  37403
Clarksville Regional Hematology/OncologyClarksville, Tennessee  37043
The Jones ClinicGermantown, Tennessee  38138
Vanderbilt University School of MedicineNashville, Tennessee  37232-6307
Clinical Hematology & OncologyDallas, Texas  75235
H. Alejandro Preti, M.D., PAHouston, Texas  77030
South Texas Oncology & HematologySan Antonio, Texas  78207
Scott & White HospitalTemple, Texas  76508
Northern Utah Cancer AssociatesOgden, Utah  84403
Southwestern Vermont Health CareBennington, Vermont  05201
Western Washington ClinicEverett, Washington  98201
West Virginia University Health Sciences CenterMorgantown, West Virginia  26506
Kettle Morain OncologyWest Bend, Wisconsin  53095