Colorectal Neoplasms Clinical Trial
Official title:
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
| NCT number | NCT00056459 |
| Other study ID # | CPTK787 0135/306241 |
| Secondary ID | CONFIRM 1 |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | February 2003 |
| Verified date | February 2020 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1168 |
| Est. completion date | |
| Est. primary completion date | January 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novartis Investigative Site | Toronto | Ontario |
| New Zealand | Novartis Investigative Site | Hamilton | |
| Slovakia | Novartis Investigative Site | Bratislava | |
| Slovakia | Novartis Investigative Site | Bratislava | |
| Slovakia | Novartis Investigative Site | Kosice | |
| Slovakia | Novartis Investigative Site | Zilina | |
| United States | St. Joseph Mercy Hospital | Ann Arbor | Michigan |
| United States | Shelby D. Rifkin, M.D. | Arlington Heights | Illinois |
| United States | Peachtree Hematology and Oncology | Atlanta | Georgia |
| United States | Southwest Regional Cancer Center | Austin | Texas |
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | St. Agnes Healthcare, Inc. | Baltimore | Maryland |
| United States | Southwestern Vermont Health Care | Bennington | Vermont |
| United States | Alabama Hematology/Oncology | Birmingham | Alabama |
| United States | Mid-Dakota Clinic PC | Bismarck | North Dakota |
| United States | Boca Raton Comprehensive Cancer Center | 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 | Charleston Cancer Center | Charleston | South Carolina |
| United States | Charleston Hematology Oncology | Charleston | South Carolina |
| United States | Carolina Medical Center | Charlotte | North Carolina |
| United States | The Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey |
| United States | North Idaho Cancer Center | Coeur d'Alene | Idaho |
| United States | South Carolina Oncology Associates | Columbia | South Carolina |
| United States | Hematology Oncology Consultants, Inc. | Columbus | Ohio |
| United States | Mid Ohio Oncology/Hematology, Inc. | Columbus | Ohio |
| United States | Corpus Christi Cancer Center | Corpus Christi | Texas |
| United States | Center for Oncology Research & Treatment, PA | Dallas | Texas |
| United States | Danville Hematology and Oncology, Inc. | Danville | Virginia |
| United States | Colorado Cancer Research Program | Denver | Colorado |
| United States | Josephine Ford Cancer Center | Detroit | Michigan |
| United States | SMDC Health System | Duluth | Minnesota |
| United States | Western Washington Medical Group | Everett | Washington |
| United States | Western Washington Medical Group | Everett | Washington |
| United States | Northern Virginia Oncology Group | Fairfax | Virginia |
| United States | Genesys Hurley Cancer Institute | Flint | Michigan |
| United States | Florida Cancer Specialists | Fort Myers | Florida |
| United States | Compassionate Cancer Care Medical Group, Inc | Fountain Valley | California |
| United States | California Oncology of the Central Valley | Fresno | California |
| United States | Virginia K. Crosson Cancer Center | Fullerton | California |
| United States | The Jones Clinic | Germantown | Tennessee |
| United States | Ronald Yanagiharaa, M.D. | Gilroy | California |
| United States | Glendale Adventist Medical Center Cancer Center | Glendale | California |
| United States | Palo Verde Hematology & Oncology | Glendale | Arizona |
| United States | CR 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 Research of Long Island | Great Neck | New York |
| United States | Cancer Center of the Carolinas | Greenville | South Carolina |
| United States | Monroe Medical Associates | Harvey | Illinois |
| United States | Hershey Medical Center | Hershey | Pennsylvania |
| United States | Memorial Healthcare System | Hollywood | Florida |
| United States | H. Alejandro Preti, MD, PA | Houston | Texas |
| United States | M.D. Anderson Cancer Center | Houston | Texas |
| United States | Oncology Consultants | Houston | Texas |
| United States | Hematology-Oncology of Indiana, PC | Indianapolis | Indiana |
| United States | Dr. Lee C. Drinkard | Irving | Texas |
| United States | Hematology and Oncology Assoc. of Southern Mississippi | Jackson | Michigan |
| United States | Florida Oncology Associates | Jacksonville | Florida |
| United States | Broome Oncology | Johnson City | New York |
| United States | Northeast Arkansas Clinic | Jonesboro | Arkansas |
| United States | Heartland Hematology/Oncology Associates, Inc. | Kansas City | Missouri |
| United States | Kansas City Oncology and Hematology Group | Kansas City | Missouri |
| United States | Cascade Cancer Center | Kirkland | Washington |
| United States | Baptist Regional Cancer Center | Knoxville | Tennessee |
| United States | Louisiana Oncology Associates | Lafayette | Louisiana |
| United States | Lakeland Regional Cancer Center | Lakeland | Florida |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Nevada Cancer Center | Las Vegas | Nevada |
| United States | New York Oncology Hematology | Latham | New York |
| United States | Markey Clinical Oncology Research Program | Lexington | Kentucky |
| United States | St. Barnabas Cancer Center | Livingston | New Jersey |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Cancer Institute Medical Group | 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 Comprehensive Cancer Care Center | Los Angeles | California |
| United States | Norton Healthcare Pavilion | Louisville | Kentucky |
| United States | Vijay Raghavan, M.D. | Louisville | Kentucky |
| United States | UW Health -- University of Wisconsin Comp | Madison | Wisconsin |
| United States | Davis, Posteraro and Wasser, MD's, LLP | Manchester | Connecticut |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Meridia Cancer Institute | Mayfield Heights | Ohio |
| United States | University of Tennessee Cancer Institute | Memphis | Tennessee |
| United States | Oncology Hematology Group of South Florida | Miami | Florida |
| United States | Innovative Medical Research of South Florida | Miami Shores | Florida |
| United States | Connecticut Oncology Group | Middletown | Connecticut |
| United States | Minnesota CGOP | Minneapolis | Minnesota |
| United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
| United States | Montana Cancer Specialists | Missoula | Montana |
| United States | Monogahela Valley Hospital | Monongahela | Pennsylvania |
| United States | Eddie Hong-Lung Hu, M.D. | Monterey Park | California |
| United States | Hematology-Oncology Associates of New Jersey | Morristown | New Jersey |
| United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
| United States | LSU Medical Center | New Orleans | Louisiana |
| United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
| United States | Medical Oncology Hematology Consultants | Newark | Delaware |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | North Valley Hematology/Oncology Medical Group | Northridge | California |
| United States | Cancer Center at Nyack Hospital | Nyack | New York |
| United States | North Utah Associates | Ogden | Utah |
| United States | Cancer Care Associates | Oklahoma City | Oklahoma |
| United States | The Methodist Cancer Center | Omaha | Nebraska |
| United States | Ventura County Hematology-Oncology Specialists | Oxnard | California |
| United States | Oncology Hematology Associates of Central Illinois, PC | Peoria | Illinois |
| United States | University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania |
| United States | Allegheny Cancer Center | Pittsburgh | Pennsylvania |
| United States | Wilshire Oncology Medical Group | Pomona | California |
| United States | Hematology Oncology Associates of Treasure | Port Saint Lucie | Florida |
| United States | Sierra View District Hospital | Porterville | California |
| United States | Kaiser Permanente Oncology Hematology | Portland | Oregon |
| United States | Cancer Treatment Centers of America | Portsmouth | Virginia |
| United States | The Lucy Curci Cancer Center | Rancho Mirage | California |
| United States | Cancer Care Associates Medical Group, Inc. | Redondo Beach | California |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Pluta Cancer Center | Rochester | New York |
| United States | Kaiser Permanente | Rockville | Maryland |
| United States | Missouri Cancer Care, PC | Saint Charles | Missouri |
| United States | Oncology Care Associates, PLLC | Saint Joseph | Michigan |
| United States | Arch Medical Services Incorporated | Saint Louis | Missouri |
| United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
| United States | Saint Louis University | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Metro Minnesota CCOP | Saint Louis Park | Minnesota |
| United States | Utah Cancer Specialists | Salt Lake City | Utah |
| United States | Pacific Hematology Oncology Associates | San Francisco | California |
| 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 | New Mexico Cancer Care | Santa Fe | New Mexico |
| United States | Coastal Hematology & Oncology | Savannah | Georgia |
| United States | Maine Center for Cancer Medicine & Blood Disorders | Scarborough | Maine |
| 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 | Scott & White Hospital | Temple | Texas |
| United States | Associated Physicians & Surgeons Clinic, L.L.C. | Terre Haute | Indiana |
| United States | Arizona Cancer Center | Tucson | Arizona |
| United States | Cancer Care Associates | Tulsa | Oklahoma |
| United States | Southern Oncology and Hematology Associates | Vineland | New Jersey |
| United States | San Diego Cancer Center Medical Group | Vista | California |
| United States | Cooper Cancer Institute | Voorhees | New Jersey |
| United States | George Washington University Medical Center | Washington | District of Columbia |
| United States | Washington Oncology-Hematology Center | Washington | District of Columbia |
| United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
| United States | Jennifer Caskey, M.D. | Wheat Ridge | Colorado |
| United States | Florida Medical Clinic, PA | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis | Bayer |
United States, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Best overall response rate | Throughout duration of study | ||
| Secondary | Tolerability and safety profile | Throughout duration of study |
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