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

Condition(s) targeted: Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Intervention: Vatalanib (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis / Schering AG, Germany, Study Chair, Affiliation: Novartis / Schering AG, Germany

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 are seeking first chemotherapy treatment

Official title: Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Progression free survival

Secondary outcome:

Overall survival

Time to progression

Time to treatment failure

Best overall response rate

Tolerability and safety profile

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Garran ACT 2605, Australia

Woolloongabba QLD 4102, Australia

Wollongong NSW 2500, Australia

Adelaide SA 5000, Australia

Nedlands WS 6009, Australia

Antwerpen 2020, Belgium

Wilrijk 2610, Belgium

Bruxelles 1200, Belgium

Anderlecht 1070, Belgium

Gent 9000, Belgium

Sao Paulo 05651-901, Brazil

Porto Alegre RS 90020-090, Brazil

Salvador BA 41825-010, Brazil

Porto Alegre CeP 90 610-000, Brazil

Sao Paulo S01308-050, Brazil

Sao Paulo S01232-910, Brazil

Praha 2 128 08, Czech Republic

Brno 656 53, Czech Republic

Praha 5 150 18, Czech Republic

Marseille cedex 05 13385, France

Strasbourg 6700, France

Marseille Cedex 9 13273, France

Essen 45122, Germany

Kiel 24116, Germany

Hannover 30625, Germany

Augsburg 86150, Germany

Frankfurt 60488, Germany

Eschweiler 52249, Germany

Erlangen 91054, Germany

Leipzig 4103, Germany

Berlin 13353, Germany

Berlin 14195, Germany

Dessau 6822, Germany

Heidelberg 69115, Germany

Magdeburg 39002, Germany

Köln 50677, Germany

Budapest H-1032, Hungary

Budapest H-1097, Hungary

Gyor H-9002, Hungary

Szeged H-6725, Hungary

Roma 144, Italy

Roma 135, Italy

Modena 41100, Italy

Torino 10126, Italy

Rozzano 20089, Italy

Genova 16132, Italy

Forli 47100, Italy

Milano 20162, Italy

GA Utrecht 3508, Netherlands

Hamilton, New Zealand

Palmerston North, New Zealand

Coimbra 3000-076, Portugal

Kosice 041 90, Slovakia

Bratislava 81250, Slovakia

Zilina 012 07, Slovakia

Bratislava 833 10, Slovakia

Alicante 3202, Spain

Malaga 29010, Spain

Madrid 28033, Spain

Madrid 28035, Spain

Zaragoza 50009, Spain

Madrid 28041, Spain

Stockholm SE-118 83, Sweden

Bern 3010, Switzerland

Thun 3600, Switzerland

Basel 4031, Switzerland

Zurich 8027, Switzerland

Zürich 8091, Switzerland

Taipei, Taiwan

Tao-Yuan, Taiwan

Tainan, Taiwan

Oxford OX3 7LJ, United Kingdom

Belfast BT9 7AB, United Kingdom

Leicester LE1 5WW, United Kingdom

Alabama Hematology/Oncology, Birmingham, Alabama 35243, United States

Arizona Cancer Center, Tucson, Arizona 85724, United States

Palo Verde Hematology & Oncology, Glendale, Arizona 85304, United States

Highlands Oncology Group, Springdale, Arkansas 72764, United States

Northeast Arkansas Clinic, Jonesboro, Arkansas 72401, United States

Ronald Yanagiharaa, M.D., Gilroy, California 95020, United States

Cancer Institute Medical Group, Los Angeles, California 90025, United States

Providence St. Joseph Medical Center, Burbank, California 91505, United States

Pacific Shores Medical Group, Long Beach, California 90813, United States

UCLA School of Medicine, Los Angeles, California 90095, United States

Compassionate Cancer Care Medical Group, Inc, Fountain Valley, California 92708, United States

The Lucy Curci Cancer Center, Rancho Mirage, California 92270, United States

Santa Clara Valley Medical Center, San Jose, California 95128, United States

USC/Norris Comprehensive Cancer Care Center, Los Angeles, California 90033, United States

Synergy Hematology-Oncology Medical Associates, Los Angeles, California 90057, United States

Comprehensive Blood and Cancer Center, Bakersfield, California 93309, United States

California Oncology of the Central Valley, Fresno, California 93710, United States

Virginia K. Crosson Cancer Center, Fullerton, California 92835, United States

Wilshire Oncology Medical Group, Pomona, California 91767, United States

Eddie Hong-Lung Hu, M.D., Monterey Park, California 91754, United States

North Valley Hematology/Oncology Medical Group, Northridge, California 91328, United States

Ventura County Hematology-Oncology Specialists, Oxnard, California 93030, United States

Sierra View District Hospital, Porterville, California 93257, United States

Cancer Care Associates Medical Group, Inc., redondo Beach, California 90277, United States

Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California 93105, United States

Sansum Santa Barbara Foundation Medical Clinic, Santa Barbara, California 93105, United States

San Diego Cancer Center Medical Group, Vista, California 92083, United States

Glendale Adventist Medical Center Cancer Center, Glendale, California 91206, United States

Pacific Hematology Oncology Associates, San Francisco, California 94904, United States

Jennifer Caskey, M.D., Wheat Ridge, Colorado 08833, United States

Colorado Cancer Research Program, Denver, Colorado 80224, United States

Davis, Posteraro and Wasser, MD's, LLP, Manchester, Connecticut 06040, United States

Connecticut Oncology Group, Middletown, Connecticut 06457, United States

Medical Oncology Hematology Consultants, Newark, Delaware 19808, United States

Washington Oncology-Hematology Center, Washington, District of Columbia 20016, United States

George Washington University Medical Center, Washington, District of Columbia 20037, United States

Innovative Medical Research of South Florida, Miami Shores, Florida 33138, United States

Lakeland Regional Cancer Center, Lakeland, Florida 33803, United States

Florida Cancer Specialists, Ft. Myers, Florida 33901, United States

Hematology Oncology Associates of Treasure, Port St. Lucie, Florida 34952, United States

Florida Oncology Associates, Jacksonville, Florida 32204, United States

Oncology Hematology Group of South Florida, Miami, Florida 33176, United States

Florida Medical Clinic, PA, Zephyrhills, Florida 33542, United States

Boca Raton Comprehensive Cancer Center, Boca Raton, Florida 33486, United States

Memorial Healthcare System, Hollywood, Florida 33021, United States

Peachtree Hematology and Oncology, Atlanta, Georgia 40202, United States

Coastal Hematology & Oncology, Savannah, Georgia 31406, United States

North Idaho Cancer Center, Couer d'Alene, Idaho 83814, United States

Northshore Cancer Research Association, Skokie, Illinois 60076, United States

Midwest Cancer Research Group, Skokie, Illinois 60077, United States

Shelby D. Rifkin, M.D., Arlington Heights, Illinois 60004, United States

Oncology Hematology Associates of Central Illinois, PC, Peoria, Illinois 61602, United States

Monroe Medical Associates, Harvey, Illinois 60426, United States

Associated Physicians & Surgeons Clinic, L.L.C., Terre Haute, Indiana 47804, United States

Hematology-Oncology of Indiana, PC, Indianapolis, Indiana 46260, United States

Norton Healthcare Pavilion, Louisville, Kentucky 40202, United States

Vijay Raghavan, M.D., Louisville, Kentucky 40215, United States

Markey Clinical Oncology Research Program, Lexington, Kentucky 40536-0098, United States

LSU Medical Center, New Orleans, Louisiana 70112, United States

Louisiana Oncology Associates, Lafayette, Louisiana 70506, United States

LSU Health Sciences Center, Shreveport, Louisiana 71130-3932, United States

Tulane University Health Sciences Center, New Orleans, Louisiana 70112, United States

Maine Center for Cancer Medicine & Blood Disorders, Scarborough, Maine 04074, United States

St. Agnes Healthcare, Inc., Baltimore, Maryland 21229-5299, United States

Kaiser Permanente, Rockville, Maryland 20850, United States

Spectrum Health -- Cook Research Dept., Grand Rapids, Michigan 49503, United States

Providence Cancer Center, Southfield, Michigan 48075, United States

Hematology and Oncology Assoc. of Southern Mississippi, Jackson, Michigan 48201, United States

Josephine Ford Cancer Center, Detroit, Michigan 48202, United States

Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States

Oncology Care Associates, PLLC, St. Joseph, Michigan 49085, United States

St. Joseph Mercy Hospital, Ann Arbor, Michigan 48106-0995, United States

SMDC Health System, Duluth, Minnesota 55805, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Metro Minnesota CCOP, St. Louis Park, Minnesota 55426, United States

Minnesota CGOP, Minneapolis, Minnesota 55407, United States

Arch Medical Services Incorporated, St. Louis, Missouri 63141, United States

Kansas City Oncology and Hematology Group, Kansas City, Missouri 64131, United States

Saint Louis University, St. Louis, Missouri 63110, United States

Missouri Cancer Care, PC, St. Charles, Missouri 63301, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Missouri Baptist Cancer Center, St. Louis, Missouri 63131, United States

Heartland Hematology/Oncology Associates, Inc., Kansas City, Missouri 64118, United States

North Central Montana Professional Building, Great Falls, Montana 59405, United States

Montana Cancer Specialists, Missoula, Montana 59807-7877, United States

The Methodist Cancer Center, Omaha, Nebraska 68114, United States

Nevada Cancer Center, Las Vegas, Nevada 89109, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89109, United States

Hematology-Oncology Associates of New Jersey, Morristown, New Jersey 07960, United States

The Center for Cancer and Hematologic Disease, Cherry Hill, New Jersey 08003, United States

St. Barnabas Cancer Center, Livingston, New Jersey 07039, United States

Cooper Cancer Institute, Voorhees, New Jersey 08043, United States

Southern Oncology and Hematology Associates, Vineland, New Jersey 08360, United States

New Mexico Cancer Care, Santa Fe, New Mexico 87505, United States

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

Cancer Research of Long Island, Great Neck, New York 11023, United States

New York Oncology Hematology, Latham, New York 12110, United States

Broome Oncology, Johnson City, New York 13790, United States

Pluta Cancer Center, Rochester, New York 14623, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Cancer Center at Nyack Hospital, Nyack, New York 10960, United States

CR Wood Cancer Center, Glen Falls, New York 12801, United States

Carolina Medical Center, Charlotte, North Carolina 28203, United States

Mid-Dakota Clinic PC, Bismarck, North Dakota 58501, United States

Nashat Gabrail, M.D., Canton, Ohio 44718, United States

Hematology Oncology Consultants, Inc., Columbus, Ohio 43235, United States

Meridia Cancer Institute, Mayfield Heights, Ohio 44124, United States

Mid Ohio Oncology/Hematology, Inc., Columbus, Ohio 43213, United States

Cancer Care Associates, Oklahoma City, Oklahoma 73112, United States

Cancer Care Associates, Tulsa, Oklahoma 74136-1929, United States

Toronto, Ontario, Canada

Hamilton, Ontario, Canada

Toronto, Ontario M5G 2M9, Canada

Kaiser Permanente Oncology Hematology, Portland, Oregon 97227, United States

Allegheny Cancer Center, Pittsburgh, Pennsylvania 15212-4772, United States

University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania 19104, United States

Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Monogahela Valley Hospital, Monogahela, Pennsylvania 15063, United States

Sainte-Foy, Quebec, Canada

Charleston Cancer Center, Charleston, South Carolina 29406, United States

Cancer Center of the Carolinas, Greenville, South Carolina 29615, United States

South Carolina Oncology Associates, Columbia, South Carolina 29201, United States

Charleston Hematology Oncology, Charleston, South Carolina 29403, United States

Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

University of Tennessee Cancer Institute, Memphis, Tennessee 38104, United States

Sarah Cannon Cancer Center, Nashville, Tennessee 37203, United States

The Jones Clinic, Germantown, Tennessee 38138, United States

Baptist Regional Cancer Center, Knoxville, Tennessee 37920, United States

M.D. Anderson Cancer Center, Houston, Texas 77030, United States

Southwest Regional Cancer Center, Austin, Texas 78705, United States

H. Alejandro Preti, MD, PA, Houston, Texas 77030, United States

Center for Oncology Research & Treatment, PA, Dallas, Texas 75230, United States

Scott & White Hospital, Temple, Texas 76508, United States

Corpus Christi Cancer Center, Corpus Christi, Texas 78412, United States

Dr. Lee C. Drinkard, Irving, Texas 75038, United States

Oncology Consultants, Houston, Texas 77024, United States

Utah Cancer Specialists, Salt Lake City, Utah 84124, United States

North Utah Associates, Ogden, Utah 84403-3105, United States

Southwestern Vermont Health Care, Bennington, Vermont 05201, United States

Northern Virginia Oncology Group, Fairfax, Virginia 22031, United States

Virginia Cancer Institute, Richmond, Virginia 23230, United States

Cancer Treatment Centers of America, Portsmouth, Virginia 23704, United States

Danville Hematology and Oncology, Inc., Danville, Virginia 24541, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Cascade Cancer Center, Kirkland, Washington 98034, United States

Western Washington Medical Group, Everett, Washington 982901, United States

Western Washington Medical Group, Everett, Washington 98201, United States

UW Health -- University of Wisconsin Comp, Madison, Wisconsin 53792, United States

Waukesha Memorial Hospital, Waukesha, Wisconsin 53188, United States

Starting date: February 2003
Ending date: May 2004
Last updated: September 6, 2007