Colorectal Neoplasms Clinical Trial
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
| Verified date | January 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 855 |
| Est. completion date | January 2007 |
| Est. primary completion date | January 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Frankston | |
| Australia | Novartis Investigative Site | Woodville South | |
| Austria | Novartis Investigative Site | St. Veit an der Glan | |
| Belgium | Novartis Investigative Site | Antwerpen | |
| Belgium | Novartis Investigative Site | Brasschaat | |
| Belgium | Novartis Investigative Site | Bruxelles | |
| Belgium | Novartis Investigative Site | Leuven | |
| Belgium | Novartis Investigative Site | Liège | |
| Belgium | Novartis Investigative Site | Wilrijk | |
| Brazil | Novartis Investigative Site | Porto Alegre RS | |
| Brazil | Novartis Investigative Site | Salvador - Ba | |
| Brazil | Novartis Investigative Site | Salvador, Bahia | |
| Brazil | Novartis Investigative Site | Sao Paulo | |
| Brazil | Novartis Investigative Site | Sao Paulo | |
| Brazil | Novartis Investigative Site | Sao Paulo | |
| Canada | Novartis Investigative Site | Barrie | Ontario |
| Canada | Novartis Investigative Site | Brampton | Ontario |
| Canada | Novartis Investigative Site | Calgary | Alberta |
| Canada | Novartis Investigative Site | Greenfield Park | Quebec |
| Canada | Novartis Investigative Site | Hamilton | Ontario |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Ottawa | Ontario |
| Canada | Novartis Investigative Site | Penticton | British Columbia |
| Canada | Novartis Investigative Site | Sainte-Foy | Ontario |
| Canada | Novartis Investigative Site | Saskatoon | Saskatchewan |
| Canada | Novartis Investigative Site | St. Catharines | Ontario |
| Canada | Novartis Investigative Site | Sudbury | Ontario |
| Canada | Novartis Investigative Site | Sydney | Nova Scotia |
| Canada | Novartis Investigative Site | Thunder Bay | Ontario |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Windsor | Ontario |
| Canada | Novartis Investigative Site | Winnepeg | Manitoba |
| France | Novartis Investigative Site | Avignon | |
| France | Novartis Investigative Site | Boulogne Cedex | |
| France | Novartis Investigative Site | Lille cedex | |
| France | Novartis Investigative Site | Marseille cedex 05 | |
| France | Novartis Investigative Site | Montpellier cedex 5 | |
| France | Novartis Investigative Site | Nice cedex 2 | |
| France | Novartis Investigative Site | Rennes cedex | |
| France | Novartis Investigative Site | Saint Herblain | |
| France | Novartis Investigative Site | Strasbourg | |
| France | Novartis Investigative Site | Toulouse cedex | |
| Germany | Novartis Investigative Site | Augsburg | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bielefeld | |
| Germany | Novartis Investigative Site | Braunschweig | |
| Germany | Novartis Investigative Site | Dessau | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hannover | |
| Germany | Novartis Investigative Site | Köln | |
| Germany | Novartis Investigative Site | Magdeburg | |
| Germany | Novartis Investigative Site | München | |
| Germany | Novartis Investigative Site | Neumünster | |
| Germany | Novartis Investigative Site | Trier | |
| Germany | Novartis Investigative Site | Ulm | |
| Germany | Novartis Investigative Site | Wiesbaden | |
| Hong Kong | Novartis Investigative Site | ChaiWan | |
| Italy | Novartis Investigative Site | Ancona | |
| Italy | Novartis Investigative Site | Bergamo | |
| Italy | Novartis Investigative Site | Brescia | |
| Italy | Novartis Investigative Site | Cremona | |
| Italy | Novartis Investigative Site | Genova | |
| Italy | Novartis Investigative Site | Livorno | |
| Italy | Novartis Investigative Site | Milano | |
| Italy | Novartis Investigative Site | Milano | |
| Italy | Novartis Investigative Site | Reggio Emilia | |
| Italy | Novartis Investigative Site | Roma | |
| Italy | Novartis Investigative Site | Roma | |
| Italy | Novartis Investigative Site | Rozzano | |
| New Zealand | Novartis Investigative Site | Auckland | |
| New Zealand | Novartis Investigative Site | Christchurch | |
| New Zealand | Novartis Investigative Site | Wellington | |
| Portugal | Novartis Investigative Site | Coimbra | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Slovakia | Novartis Investigative Site | Bratislava | |
| Spain | Novartis Investigative Site | Cordoba | |
| Spain | Novartis Investigative Site | Elche | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | |
| Spain | Novartis Investigative Site | Zaragoza | |
| Sweden | Novartis Investigative Site | Goteborg | |
| Sweden | Novartis Investigative Site | Stockholm | |
| Switzerland | Novartis Investigative Site | Bern | |
| Switzerland | Novartis Investigative Site | Thun | |
| Taiwan | Novartis Investigative Site | Changhua | |
| Taiwan | Novartis Investigative Site | Kaohsiung | |
| Taiwan | Novartis Investigative Site | Keelung | |
| Taiwan | Novartis Investigative Site | Taichung | |
| Taiwan | Novartis Investigative Site | Tainan | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Tao-Yuan | |
| United Kingdom | Novartis Investigative Site | Belfast | |
| United Kingdom | Novartis Investigative Site | Birmingham | |
| United Kingdom | Novartis Investigative Site | Cardiff | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Manchester | |
| United States | Hematology/Oncology Associates | Albuquerque | New Mexico |
| United States | New Mexico Oncology/Hematology | Albuquerque | New Mexico |
| United States | Cabrini Center for Cancer Care | Alexandria | Louisiana |
| United States | Harrington Cancer Center | Amarillo | Texas |
| United States | Alaska Oncology and Hematology | Anchorage | Alaska |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Franklin Square Hospital Center | Baltimore | Maryland |
| United States | St. Agnes Healthcare | Baltimore | Maryland |
| United States | Southwestern Vermont Health Care | Bennington | Vermont |
| United States | The Center for Hematology and Oncology | Boca Raton | Florida |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Providence St. Joseph Medical Center | Burbank | California |
| United States | Nashat Gabrail, M.D. | Canton | Ohio |
| United States | Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
| United States | Charleston Cancer Center | Charleston | South Carolina |
| United States | Carolinas Hematology/Oncology Associates | Charlotte | North Carolina |
| United States | Erlanger Health System | Chattanooga | Tennessee |
| United States | Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey |
| United States | University of Chicago medical Center, Hematology/Oncology | Chicago | Illinois |
| United States | Clarksville Regional Hematology/Oncology | Clarksville | Tennessee |
| United States | Case Western Reserve University | Cleveland | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | North Idaho Cancer Center | Coeur d'Alene | Idaho |
| United States | South Carolina Oncology Associates | Columbia | South Carolina |
| United States | WJB Dom VAMC | Columbia | South Carolina |
| United States | Columbus CCOP | Columbus | Ohio |
| United States | Center for Oncology Research & Treatment | Dallas | Texas |
| United States | Clinical Hematology & Oncology | Dallas | Texas |
| United States | Mile High Oncology | Denver | Colorado |
| United States | Rocky Mountain Cancer Center | Denver | Colorado |
| United States | Consultants in Medical Oncology & Hematology | Drexel Hill | Pennsylvania |
| United States | Hematology & Oncology Associates of NE PA | Dunmore | Pennsylvania |
| United States | Hematology/Oncology Associates of Central NY | East Syracuse | New York |
| United States | Western Washington Clinic | Everett | Washington |
| United States | Fort Wayne Medical Oncology & Hematology, Inc. | Fort Wayne | Indiana |
| United States | Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California |
| United States | Queens Medical Associates, PC | Fresh Meadows | New York |
| United States | California Oncology of the Central Valley | Fresno | California |
| United States | Florida Cancer Specialists | Ft. Myers | Florida |
| United States | Virginia K. Crosson Cancer Center | Fullerton | California |
| United States | The Jones Clinic | Germantown | Tennessee |
| United States | Glendale Adventist Medical Center | Glendale | California |
| United States | Charles R. Wood Cancer Center | Glens Falls | New York |
| United States | Spectrum Health -- Cook Research Dept. | Grand Rapids | Michigan |
| United States | North Central Montana Professional Building | Great Falls | Montana |
| United States | Cancer Center of the Carolinas | Greenville | South Carolina |
| United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
| United States | NH Oncology-Hematology, PA | Hooksett | New Hampshire |
| United States | H. Alejandro Preti, M.D., PA | Houston | Texas |
| United States | M.D. Anderson Cancer Center | Houston | Texas |
| United States | Oncology Consultants | Houston | Texas |
| United States | Comprehensive Cancer Institute | Huntsville | Alabama |
| United States | Northeast Arkansas Clinic | Jonesboro | Arkansas |
| United States | Heartland Hematology | Kansas City | Missouri |
| United States | Cascade Cancer Center | Kirkland | Washington |
| United States | Baptist Regional Cancer Center | Knoxville | Tennessee |
| United States | Scripps Green Hospital | La Jolla | California |
| United States | Wilshire Oncology Medical Group | La Verne | California |
| United States | Hematology Oncology Associates | Lake Worth | Florida |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Nevada Cancer Center | Las Vegas | Nevada |
| United States | Arkansas Cancer Research Center | Little Rock | Arkansas |
| United States | Little Rock Hematology & Oncology | Little Rock | Arkansas |
| United States | St. Barnabas Cancer Center | Livingston | New Jersey |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Novartis Investigative Site | Los Angeles | California |
| United States | Synergy Hematology-Oncology Medical Associates | Los Angeles | California |
| United States | UCLA School of Medicine | Los Angeles | California |
| United States | USC Norris Cancer Center | Los Angeles | California |
| United States | Vijay Raghaven, M.D. | Louisville | Kentucky |
| United States | Manchester Hematology/Oncology Assoc. | Manchester | Connecticut |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Atlanta Cancer Care | Marietta | Georgia |
| United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
| United States | Oncology/Hematology Group of South Florida | Miami | Florida |
| United States | University of Miami School of Medicine | Miami | Florida |
| United States | Minnesota CGOP | Minneapolis | Minnesota |
| United States | Monongahela Valley Hospital | Monongahela | Pennsylvania |
| United States | Eddie Hong-Lung Hu, M.D. | Monterey Park | California |
| United States | West Virginia University Health Sciences Center | Morgantown | West Virginia |
| United States | Hematology Oncology Associates of Northern New Jersey | Morristown | New Jersey |
| United States | Munster Community Hospital | Munster | Indiana |
| United States | Meharry Medical College | Nashville | Tennessee |
| United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
| United States | Vanderbilt University School of Medicine | Nashville | Tennessee |
| United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
| United States | LSU Medical Center | New Orleans | Louisiana |
| United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
| United States | St. Vincent's Catholic Medical Centers of New York | New York | New York |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | North Valley Hematology/Oncology Medical Group | Northridge | California |
| United States | Hematology-Oncology Associates of Rockland | Nyack | New York |
| United States | Northern Utah Cancer Associates | Ogden | Utah |
| United States | The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Medical Oncology Care Associates | Orange | California |
| United States | Owensboro Medical Health System | Owensboro | Kentucky |
| United States | Ventura County Hematology-Oncology Specialists | Oxnard | California |
| United States | Oncology Hematology Associates of Central Illinois, PC | Peoria | Illinois |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | UPMC Cancer Pavillion | Pittsburgh | Pennsylvania |
| United States | Hematology Oncology Associates of Treasure Coast | Port St. Lucie | Florida |
| United States | Sierra View District Hospital | Porterville | California |
| United States | Cancer Treatment Centers of America in Hampton Roads | Portsmouth | Virginia |
| United States | Rainier Oncology | Puyallup | Washington |
| United States | Cancer Care Associates Medical Group, Inc. | Redondo Beach | California |
| United States | James P. Wilmot Cancer Center | Rochester | New York |
| United States | Pluta Cancer Center | Rochester | New York |
| United States | Kaiser Permanente | Rockville | Maryland |
| United States | South Texas Oncology & Hematology | San Antonio | Texas |
| United States | Santa Clara Valley Medical Center | San Jose | California |
| United States | Sansum Santa Barbara Foundation Medical Clinic | Santa Barbara | California |
| United States | Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California |
| United States | Coastal Hematology & Oncology | Savannah | Georgia |
| United States | Office of Research | Savannah | Georgia |
| United States | Maine Center for Cancer Medicine & Blood Disorders | Scarborough | Maine |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | LSU Health Sciences Center | Shreveport | Louisiana |
| United States | Midwest Cancer Research Group | Skokie | Illinois |
| United States | Northshore Cancer Research Association | Skokie | Illinois |
| United States | Providence Cancer Center | Southfield | Michigan |
| United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
| United States | Highlands Oncology Group | Springdale | Arkansas |
| United States | Missouri Cancer Care, PC | St. Charles | Missouri |
| United States | Oncology Care Associates, PLLC | St. Joseph | Michigan |
| United States | Arch Medical Services Incorporated | St. Louis | Missouri |
| United States | Missouri Baptist Cancer Center | St. Louis | Missouri |
| United States | Saint Louis University | St. Louis | Missouri |
| United States | Washington University School of Medicine | St. Louis | Missouri |
| United States | Scott & White Hospital | Temple | Texas |
| United States | Lewis Hall Singletary Oncology Center | Thomasville | Georgia |
| United States | Cotton O'Neil Oncology Clinic | Topeka | Kansas |
| United States | Arizona Clinical Research Center | Tucson | Arizona |
| United States | Oklahoma Oncology, Inc. | Tulsa | Oklahoma |
| United States | San Diego Cancer Center Medical Group | Vista | California |
| United States | Cooper Cancer Center | Voorhees | New Jersey |
| United States | Washington Oncology/Hematology Center | Washington | District of Columbia |
| United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
| United States | Kettle Morain Oncology | West Bend | Wisconsin |
| United States | Fallon Clinic at Worcester Medical Center | Worcester | Massachusetts |
| United States | Florida Medical Clinic | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals | Bayer |
United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, Italy, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
Van Cutsem E, Bajetta E, Valle J, Köhne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | throughout duration of study | ||
| Secondary | Progression free survival | throughout duration of study | ||
| Secondary | Time to progression | throughout duration of study | ||
| Secondary | Time to treatment failure | throughout duration of study | ||
| Secondary | Tumor response rate | throughout duration of study | ||
| Secondary | Tolerability and safety profile | throughout duration of study |
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