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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00056446
Collaborator
Bayer (Industry)
855
251
2
48
3.4
0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
855 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jan 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Oxaliplatin/5-FU/LV and PTK787/ZK 222584

Drug: Vatalanib
Other Names:
  • PTK787/ZK 222584
  • Placebo Comparator: 2

    Oxaliplatin/5-FU/LV and placebo

    Drug: Vatalanib
    Other Names:
  • PTK787/ZK 222584
  • Outcome Measures

    Primary Outcome Measures

    1. Overall survival [throughout duration of study]

    Secondary Outcome Measures

    1. Progression free survival [throughout duration of study]

    2. Time to progression [throughout duration of study]

    3. Time to treatment failure [throughout duration of study]

    4. Tumor response rate [throughout duration of study]

    5. Tolerability and safety profile [throughout duration of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Institute Huntsville Alabama United States 35801
    2 Alaska Oncology and Hematology Anchorage Alaska United States 99508
    3 Arizona Clinical Research Center Tucson Arizona United States 85712
    4 Northeast Arkansas Clinic Jonesboro Arkansas United States 72401
    5 Arkansas Cancer Research Center Little Rock Arkansas United States 72205
    6 Little Rock Hematology & Oncology Little Rock Arkansas United States 72205
    7 Highlands Oncology Group Springdale Arkansas United States 72764
    8 Comprehensive Blood and Cancer Center Bakersfield California United States 93309
    9 Providence St. Joseph Medical Center Burbank California United States 91505
    10 Compassionate Cancer Care Medical Group, Inc. Fountain Valley California United States 92708
    11 California Oncology of the Central Valley Fresno California United States 93710
    12 Virginia K. Crosson Cancer Center Fullerton California United States 92835
    13 Glendale Adventist Medical Center Glendale California United States 91206
    14 Scripps Green Hospital La Jolla California United States 92037
    15 Wilshire Oncology Medical Group La Verne California United States 91767
    16 Pacific Shores Medical Group Long Beach California United States 90813
    17 USC Norris Cancer Center Los Angeles California United States 90033
    18 Synergy Hematology-Oncology Medical Associates Los Angeles California United States 90036
    19 Novartis Investigative Site Los Angeles California United States 90095
    20 UCLA School of Medicine Los Angeles California United States 90095
    21 Eddie Hong-Lung Hu, M.D. Monterey Park California United States 91754
    22 North Valley Hematology/Oncology Medical Group Northridge California United States 91328
    23 Medical Oncology Care Associates Orange California United States 92868
    24 Ventura County Hematology-Oncology Specialists Oxnard California United States 93030
    25 Sierra View District Hospital Porterville California United States 93257
    26 Cancer Care Associates Medical Group, Inc. Redondo Beach California United States 90277
    27 Santa Clara Valley Medical Center San Jose California United States 95128
    28 Sansum Santa Barbara Foundation Medical Clinic Santa Barbara California United States 93105
    29 Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara California United States 93105
    30 San Diego Cancer Center Medical Group Vista California United States 92083
    31 Mile High Oncology Denver Colorado United States 80210
    32 Rocky Mountain Cancer Center Denver Colorado United States 80220
    33 Manchester Hematology/Oncology Assoc. Manchester Connecticut United States 06040
    34 Washington Oncology/Hematology Center Washington District of Columbia United States 20037
    35 The Center for Hematology and Oncology Boca Raton Florida United States 33486
    36 Florida Cancer Specialists Ft. Myers Florida United States 33901
    37 Hematology Oncology Associates Lake Worth Florida United States 33461-4710
    38 University of Miami School of Medicine Miami Florida United States 33136
    39 Oncology/Hematology Group of South Florida Miami Florida United States 33176
    40 Hematology Oncology Associates of Treasure Coast Port St. Lucie Florida United States 34952
    41 Florida Medical Clinic Zephyrhills Florida United States 33542
    42 Atlanta Cancer Care Marietta Georgia United States 30060
    43 Office of Research Savannah Georgia United States 31405
    44 Coastal Hematology & Oncology Savannah Georgia United States 31406
    45 Lewis Hall Singletary Oncology Center Thomasville Georgia United States 31792
    46 North Idaho Cancer Center Coeur d'Alene Idaho United States 83814
    47 University of Chicago medical Center, Hematology/Oncology Chicago Illinois United States 60637
    48 Oncology Hematology Associates of Central Illinois, PC Peoria Illinois United States 61602
    49 Northshore Cancer Research Association Skokie Illinois United States 60076
    50 Midwest Cancer Research Group Skokie Illinois United States 60077
    51 Fort Wayne Medical Oncology & Hematology, Inc. Fort Wayne Indiana United States 46815
    52 Munster Community Hospital Munster Indiana United States 46321
    53 Cotton O'Neil Oncology Clinic Topeka Kansas United States 66606
    54 Vijay Raghaven, M.D. Louisville Kentucky United States 40215
    55 Owensboro Medical Health System Owensboro Kentucky United States 42303
    56 Cabrini Center for Cancer Care Alexandria Louisiana United States 71301
    57 LSU Medical Center New Orleans Louisiana United States 70112
    58 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    59 LSU Health Sciences Center Shreveport Louisiana United States 71130-3932
    60 Maine Center for Cancer Medicine & Blood Disorders Scarborough Maine United States 04074
    61 St. Agnes Healthcare Baltimore Maryland United States 21229-5299
    62 Franklin Square Hospital Center Baltimore Maryland United States 21237
    63 Kaiser Permanente Rockville Maryland United States 20850
    64 Fallon Clinic at Worcester Medical Center Worcester Massachusetts United States 01605
    65 University of Michigan Ann Arbor Michigan United States 48109-0934
    66 Spectrum Health -- Cook Research Dept. Grand Rapids Michigan United States 49503
    67 Providence Cancer Center Southfield Michigan United States 48075
    68 Oncology Care Associates, PLLC St. Joseph Michigan United States 49085
    69 Minnesota CGOP Minneapolis Minnesota United States 55407
    70 Heartland Hematology Kansas City Missouri United States 64118
    71 Missouri Cancer Care, PC St. Charles Missouri United States 63301
    72 Saint Louis University St. Louis Missouri United States 63110
    73 Washington University School of Medicine St. Louis Missouri United States 63110
    74 Missouri Baptist Cancer Center St. Louis Missouri United States 63131
    75 Arch Medical Services Incorporated St. Louis Missouri United States 63141
    76 North Central Montana Professional Building Great Falls Montana United States 59405
    77 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89109
    78 Nevada Cancer Center Las Vegas Nevada United States 89109
    79 NH Oncology-Hematology, PA Hooksett New Hampshire United States 03106
    80 Center for Cancer and Hematologic Disease Cherry Hill New Jersey United States 08003
    81 St. Barnabas Cancer Center Livingston New Jersey United States 07039
    82 Hematology Oncology Associates of Northern New Jersey Morristown New Jersey United States 07960
    83 Cooper Cancer Center Voorhees New Jersey United States 08043
    84 Hematology/Oncology Associates Albuquerque New Mexico United States 87102
    85 New Mexico Oncology/Hematology Albuquerque New Mexico United States 87109
    86 Roswell Park Cancer Institute Buffalo New York United States 14263
    87 Hematology/Oncology Associates of Central NY East Syracuse New York United States 13057
    88 Queens Medical Associates, PC Fresh Meadows New York United States 11365
    89 Charles R. Wood Cancer Center Glens Falls New York United States 12801
    90 North Shore University Hospital Manhasset New York United States 11030
    91 St. Vincent's Catholic Medical Centers of New York New York New York United States 10011
    92 Hematology-Oncology Associates of Rockland Nyack New York United States 10956
    93 Pluta Cancer Center Rochester New York United States 14623
    94 James P. Wilmot Cancer Center Rochester New York United States 14642
    95 Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599-7305
    96 Carolinas Hematology/Oncology Associates Charlotte North Carolina United States 28203
    97 Nashat Gabrail, M.D. Canton Ohio United States 44718
    98 Case Western Reserve University Cleveland Ohio United States 44106-5056
    99 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    100 Columbus CCOP Columbus Ohio United States 43206
    101 The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    102 Oklahoma Oncology, Inc. Tulsa Oklahoma United States 74104
    103 Consultants in Medical Oncology & Hematology Drexel Hill Pennsylvania United States 19026
    104 Hematology & Oncology Associates of NE PA Dunmore Pennsylvania United States 18512
    105 Penn State Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    106 Monongahela Valley Hospital Monongahela Pennsylvania United States 15063
    107 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    108 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212-4772
    109 UPMC Cancer Pavillion Pittsburgh Pennsylvania United States 15232
    110 Charleston Cancer Center Charleston South Carolina United States 29406
    111 South Carolina Oncology Associates Columbia South Carolina United States 29201
    112 WJB Dom VAMC Columbia South Carolina United States 29209
    113 Cancer Center of the Carolinas Greenville South Carolina United States 29615
    114 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    115 Erlanger Health System Chattanooga Tennessee United States 37403
    116 Clarksville Regional Hematology/Oncology Clarksville Tennessee United States 37043
    117 The Jones Clinic Germantown Tennessee United States 38138
    118 Baptist Regional Cancer Center Knoxville Tennessee United States 37920
    119 University of Tennessee Cancer Institute Memphis Tennessee United States 38104
    120 Sarah Cannon Cancer Center Nashville Tennessee United States 37203
    121 Meharry Medical College Nashville Tennessee United States 37208
    122 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37212
    123 Vanderbilt University School of Medicine Nashville Tennessee United States 37232-6307
    124 Harrington Cancer Center Amarillo Texas United States 79106
    125 Center for Oncology Research & Treatment Dallas Texas United States 75230
    126 Clinical Hematology & Oncology Dallas Texas United States 75235
    127 Oncology Consultants Houston Texas United States 77024
    128 H. Alejandro Preti, M.D., PA Houston Texas United States 77030
    129 M.D. Anderson Cancer Center Houston Texas United States 77030
    130 South Texas Oncology & Hematology San Antonio Texas United States 78207
    131 Scott & White Hospital Temple Texas United States 76508
    132 Northern Utah Cancer Associates Ogden Utah United States 84403
    133 Southwestern Vermont Health Care Bennington Vermont United States 05201
    134 Virginia Oncology Associates Norfolk Virginia United States 23502
    135 Cancer Treatment Centers of America in Hampton Roads Portsmouth Virginia United States 23704
    136 Western Washington Clinic Everett Washington United States 98201
    137 Cascade Cancer Center Kirkland Washington United States 98034
    138 Rainier Oncology Puyallup Washington United States 98372
    139 Virginia Mason Medical Center Seattle Washington United States 98101
    140 Swedish Cancer Institute Seattle Washington United States 98104
    141 West Virginia University Health Sciences Center Morgantown West Virginia United States 26506
    142 Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    143 Kettle Morain Oncology West Bend Wisconsin United States 53095
    144 Novartis Investigative Site Frankston Australia VIC
    145 Novartis Investigative Site Woodville South Australia SA
    146 Novartis Investigative Site St. Veit an der Glan Austria 9300
    147 Novartis Investigative Site Antwerpen Belgium 2020
    148 Novartis Investigative Site Brasschaat Belgium 2930
    149 Novartis Investigative Site Bruxelles Belgium 1200
    150 Novartis Investigative Site Leuven Belgium
    151 Novartis Investigative Site Liège Belgium 4000
    152 Novartis Investigative Site Wilrijk Belgium 2610
    153 Novartis Investigative Site Porto Alegre RS Brazil CEP 90 610-000
    154 Novartis Investigative Site Salvador - Ba Brazil 41825-010
    155 Novartis Investigative Site Salvador, Bahia Brazil CEP 40170-070
    156 Novartis Investigative Site Sao Paulo Brazil 01236-000
    157 Novartis Investigative Site Sao Paulo Brazil 01308-050
    158 Novartis Investigative Site Sao Paulo Brazil 01406-100
    159 Novartis Investigative Site Calgary Alberta Canada T2N4N2
    160 Novartis Investigative Site Penticton British Columbia Canada V2A3G6
    161 Novartis Investigative Site Winnepeg Manitoba Canada R2H 2A6
    162 Novartis Investigative Site Sydney Nova Scotia Canada B1P 1P3
    163 Novartis Investigative Site Barrie Ontario Canada L4M6M2
    164 Novartis Investigative Site Brampton Ontario Canada L6W 2Z8
    165 Novartis Investigative Site Hamilton Ontario Canada L8V 5C2
    166 Novartis Investigative Site Ottawa Ontario Canada K1H 1C4
    167 Novartis Investigative Site Sainte-Foy Ontario Canada G1V 4G5
    168 Novartis Investigative Site St. Catharines Ontario Canada L2R5K3
    169 Novartis Investigative Site Sudbury Ontario Canada P3E 5J1
    170 Novartis Investigative Site Thunder Bay Ontario Canada P7A 7T1
    171 Toronto Ontario Canada M4C 3E7
    172 Novartis Investigative Site Toronto Ontario Canada M4N3M5
    173 Novartis Investigative Site Toronto Ontario Canada M5G1X5
    174 Novartis Investigative Site Toronto Ontario Canada
    175 Novartis Investigative Site Windsor Ontario Canada N8W 2X3
    176 Novartis Investigative Site Greenfield Park Quebec Canada J4V2H1
    177 Novartis Investigative Site Montreal Quebec Canada H2L 4M1
    178 Novartis Investigative Site Montreal Quebec Canada H2W 1S6
    179 Novartis Investigative Site Saskatoon Saskatchewan Canada S7N4H4
    180 Novartis Investigative Site Avignon France 84000
    181 Novartis Investigative Site Boulogne Cedex France 92104
    182 Novartis Investigative Site Lille cedex France 59020
    183 Novartis Investigative Site Marseille cedex 05 France 13385
    184 Novartis Investigative Site Montpellier cedex 5 France 34298
    185 Novartis Investigative Site Nice cedex 2 France 6189
    186 Novartis Investigative Site Rennes cedex France 35042
    187 Novartis Investigative Site Saint Herblain France 44805
    188 Novartis Investigative Site Strasbourg France 67000
    189 Novartis Investigative Site Toulouse cedex France 31052
    190 Novartis Investigative Site Augsburg Germany 86150
    191 Novartis Investigative Site Berlin Germany 13585
    192 Novartis Investigative Site Berlin Germany 14195
    193 Novartis Investigative Site Bielefeld Germany 33604
    194 Novartis Investigative Site Braunschweig Germany 38100
    195 Novartis Investigative Site Dessau Germany 6822
    196 Novartis Investigative Site Dresden Germany 1307
    197 Novartis Investigative Site Essen Germany 45122
    198 Novartis Investigative Site Essen Germany 45136
    199 Novartis Investigative Site Frankfurt Germany 60488
    200 Novartis Investigative Site Hamburg Germany 22087
    201 Novartis Investigative Site Hannover Germany 30625
    202 Novartis Investigative Site Köln Germany 50677
    203 Novartis Investigative Site Magdeburg Germany 39002
    204 Novartis Investigative Site München Germany 81675
    205 Novartis Investigative Site Neumünster Germany 24534
    206 Novartis Investigative Site Trier Germany 54290
    207 Novartis Investigative Site Ulm Germany 89081
    208 Novartis Investigative Site Wiesbaden Germany 65199
    209 Novartis Investigative Site ChaiWan Hong Kong
    210 Novartis Investigative Site Ancona Italy 60020
    211 Novartis Investigative Site Bergamo Italy 24128
    212 Novartis Investigative Site Brescia Italy 25124
    213 Novartis Investigative Site Cremona Italy 26100
    214 Novartis Investigative Site Genova Italy 16132
    215 Novartis Investigative Site Livorno Italy 57100
    216 Novartis Investigative Site Milano Italy 20100
    217 Novartis Investigative Site Milano Italy 20141
    218 Novartis Investigative Site Reggio Emilia Italy 42100
    219 Novartis Investigative Site Roma Italy 135
    220 Novartis Investigative Site Roma Italy 149
    221 Novartis Investigative Site Rozzano Italy 20089
    222 Novartis Investigative Site Auckland New Zealand
    223 Novartis Investigative Site Christchurch New Zealand
    224 Novartis Investigative Site Wellington New Zealand
    225 Novartis Investigative Site Coimbra Portugal 3000-076
    226 Novartis Investigative Site Lisboa Portugal 1649-035
    227 Novartis Investigative Site Bratislava Slovakia 81250
    228 Novartis Investigative Site Cordoba Spain 14004
    229 Novartis Investigative Site Elche Spain 3202
    230 Novartis Investigative Site Madrid Spain 28007
    231 Novartis Investigative Site Madrid Spain 28033
    232 Novartis Investigative Site Madrid Spain 28040
    233 Novartis Investigative Site Madrid Spain 8907
    234 Novartis Investigative Site Malaga Spain 29010
    235 Novartis Investigative Site Zaragoza Spain 5009
    236 Novartis Investigative Site Goteborg Sweden SE-416 85
    237 Novartis Investigative Site Stockholm Sweden SE-118 83
    238 Novartis Investigative Site Bern Switzerland 3010
    239 Novartis Investigative Site Thun Switzerland 3600
    240 Novartis Investigative Site Changhua Taiwan
    241 Novartis Investigative Site Kaohsiung Taiwan
    242 Novartis Investigative Site Keelung Taiwan
    243 Novartis Investigative Site Taichung Taiwan
    244 Novartis Investigative Site Tainan Taiwan
    245 Novartis Investigative Site Taipei Taiwan
    246 Novartis Investigative Site Tao-Yuan Taiwan
    247 Novartis Investigative Site Belfast United Kingdom BT9 7AB
    248 Novartis Investigative Site Birmingham United Kingdom B15 2TH
    249 Novartis Investigative Site Cardiff United Kingdom CF147TB
    250 Novartis Investigative Site London United Kingdom W1T 3AA
    251 Novartis Investigative Site Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Novartis Pharmaceuticals
    • Bayer

    Investigators

    • Study Chair: Novartis/Schering AG, Germany, Novartis / Schering AG Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00056446
    Other Study ID Numbers:
    • CPTK787 0133/304946
    • NCT00068679
    First Posted:
    Mar 14, 2003
    Last Update Posted:
    Mar 6, 2017
    Last Verified:
    Jan 1, 2016

    Study Results

    No Results Posted as of Mar 6, 2017