A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
Description
Detailed Description
OBJECTIVES:
Primary
- To compare disease-free survival of patients with resected stage III colon cancer
treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and
leucovorin calcium with versus without celecoxib.
Secondary
- To contribute to an international prospective pooled analysis comparing disease-free
survival of patients treated with these regimens.
- To compare overall survival at 3 years of patients treated with these regimens.
- To contribute to an international prospective pooled analysis comparing disease-free
survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
- To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients.
- To assess differences in cardiovascular-specific events in patients treated with versus
without celecoxib.
- To evaluate differences in toxicities, particularly cumulative peripheral neuropathy,
in patients treated with 6 versus 12 courses of FOLFOX chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to number of
positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs
no). Patients are randomized to 1 of 4 treatment arms.
NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7)
should be stratified to 1-3 nodes.
- Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2
hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients
also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2 of
FOLFOX. Courses repeat every 14 days for 12 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14
beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the
absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14
days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm IV: Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days
for 6 courses in the absence of disease progression or unacceptable toxicity.
In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of
disease progression or unacceptable toxicity.
Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies.
After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for years 2-3, and then annually for 3 years.
Phase
N/AInclusion and Exclusion Criteria
- Histologically confirmed adenocarcinoma of the colon
- Stage III disease
- The gross inferior (caudal) margin of the primary tumor must lie above the peritoneal reflection
- No rectal cancer
- Synchronous colon cancers allowed
- No synchronous colon and rectal primary tumors
- Completely resected tumor
- Patients with adherent to adjacent structures, en bloc R
Sites
-
California
- St. Joseph Hospital Regional Cancer Center - Orange, Orange, California, 92868
- Desert Regional Medical Center Comprehensive Cancer Center, Palm Springs, California, 92262
- Kaiser Permanente Medical Office -Vandever Medical Office, San Diego, California, 92108
- Naval Medical Center - San Diego, San Diego, California, 92134
- Unknown facility, Pismo Beach, California, 93449
- Mercy Cancer Center at Mercy Medical Center, Merced, California, 95340
- Salinas Valley Memorial Hospital, Salinas, California, 93901
- Community Hospital of the Monterey Peninsula Comprehensive Cancer Center, Monterey, California, 93940
- Kaiser Permanente Medical Center - Santa Teresa, San Jose, California, 95119
- Santa Clara Valley Medical Center, San Jose, California, 95128
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus, Santa Clara, California, 95051
- Camino Medical Group - Treatment Center, Mountain View, California, 94040
- Kaiser Permanente - Fremont, Fremont, California, 94538
- Palo Alto Medical Foundation, Palo Alto, California, 94301
- Kaiser Permanente Medical Facility - Stockton, Stockton, California, 95210
- Kaiser Permanente Medical Center - Redwood City, Redwood City, California, 94063
- Kaiser Permanente Medical Center - Hayward, Hayward, California, 94545
- Kaiser Permanente - Deer Valley, Antioch, California, 94531
- East Bay Medical Oncology Hematology Associates - Antioch, Antioch, California, 94531
- East Bay Medical Oncology Hematology Associates - San Leandro, San Leandro, California, 94578
- Peninsula Medical Center, Burlingame, California, 94010
- John Muir/Mt. Diablo Comprehensive Cancer Center, Walnut Creek, California, 94598
- Kaiser Permanente Medical Center - Walnut Creek, Walnut Creek, California, 94596
- Kaiser Permanente Medical Center - South San Francisco, South San Francisco, California, 94080
- Kaiser Permanente Medical Center - Oakland, Oakland, California, 94611
- Diablo Valley Oncology and Hematology Medical Group - Pleasant Hill, Pleasant Hill, California, 94523
- East Bay Medical Oncology Hematology Associates - Pleasant Hill, Pleasant Hill, California, 94523
- Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco, California, 94115
- California Pacific Medical Center - California Campus, San Francisco, California, 94118
- South Sacramento Kaiser-Permanente Medical Center, Sacramento, California, 95823
- Kaiser Permanente Medical Center - Richmond, Richmond, California, 94801
- Kaiser Permanente Medical Center - Sacramento, Sacramento, California, 95825
- Kaiser Permanente Medical Center - Vallejo, Vallejo, California, 94589
- Sutter Solano Medical Center, Vallejo, California, 94589
- California Cancer Care, Incorporated - Greenbrae, Greenbrae, California, 94904
- Kaiser Permanente Medical Center - Roseville, Roseville, California, 95661
- Kaiser Foundation Hospital - San Rafael, San Rafael, California, 94903
- Kaiser Permanente Medical Center - Vacaville, Vacaville, California, 95688
- Sutter Health - Western Division Cancer Research Group, Novato, California, 94945
- Tahoe Forest Cancer Center, Truckee, California, 96161
- Saint Helena Hospital, Saint Helena, California, 94574
- Sutter Pacific Medical Foundation, Santa Rosa, California, 95403
- Kaiser Permanente Medical Center - Santa Rosa, Santa Rosa, California, 95403
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP, Marysville, California, 95901
- Feather River Hospital Cancer Center, Paradise, California, 95969
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Idaho
- Mountain States Tumor Institute at St. Luke's, Twin Falls, Idaho, 83301
- Saint Luke's Mountain States Tumor Institute, Nampa, Idaho, 83686
- Mountain States Tumor Institute - Meridian, Meridian, Idaho, 83642
- Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, 83712
- Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland, Idaho, 83619
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Colorado
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, 81502
- Valley View Hospital Cancer Center, Glenwood Springs, Colorado, 81601
- San Luis Valley Regional Medical Center, Alamosa, Colorado, 81101
- Shaw Regional Cancer Center, Edwards, Colorado, 81632
- St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, 81004
- Littleton Adventist Hospital, Littleton, Colorado, 80122
- Swedish Medical Center, Englewood, Colorado, 80110
- St. Anthony Central Hospital, Denver, Colorado, 80204
- Sky Ridge Medical Center, Lone Tree, Colorado, 80124
- Porter Adventist Hospital, Denver, Colorado, 80210
- St. Joseph Hospital, Denver, Colorado, 80218
- CCOP - Colorado Cancer Research Program, Denver, Colorado, 80222
- Kaiser Permanente - Denver, Denver, Colorado, 80205
- Kaiser Permanente - Lafayette, Lafayette, Colorado, 80026
- Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220
- Rose Medical Center, Denver, Colorado, 80220
- Aurora Presbyterian Hospital, Aurora, Colorado, 80012
- Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, 80501
- Parker Adventist Hospital, Parker, Colorado, 80138
- McKee Medical Center, Loveland, Colorado, 80539
- Front Range Cancer Specialists, Fort Collins, Colorado, 80528
- North Colorado Medical Center, Greeley, Colorado, 80631
-
Oregon
- Willamette Falls Hospital, Oregon City, Oregon, 97045
- Providence Newberg Medical Center, Newberg, Oregon, 97132
- Clackamas Radiation Oncology Center, Clackamas, Oregon, 97015
- Providence Milwaukie Hospital, Milwaukie, Oregon, 97222
- CCOP - Columbia River Oncology Program, Portland, Oregon, 97225
- Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, 97227
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Washington
- St. Mary Regional Cancer Center at St. Mary Medical Center, Walla Walla, Washington, 99362
- Northwest Cancer Specialists at Vancouver Cancer Center, Vancouver, Washington, 98684
- Southwest Washington Medical Center Cancer Center, Vancouver, Washington, 98664
- Legacy Salmon Creek Medical Center, Vancouver, Washington, 98686
- Minor and James Medical, PLLC, Seattle, Washington, 98104
-
Texas
- Harrington Cancer Center, Amarillo, Texas, 79106
- Hendrick Cancer Center, Abilene, Texas, 79601
- Seton Shivers Cancer Program at Brackenridge Hospital, Austin, Texas, 78701
- Parkland Memorial Hospital, Dallas, Texas, 75235
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390
- St. Joseph Regional Cancer Center, Bryan, Texas, 77802
- Ben Taub General Hospital, Houston, Texas, 77030
- Baylor University Medical Center - Houston, Houston, Texas, 77030
- Veterans Affairs Medical Center - Houston, Houston, Texas, 77030
-
Wyoming
- Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, 82801
-
Montana
- Benefis Sletten Cancer Institute, Great Falls, Montana, 59405
-
Kansas
- Hays Medical Center, Hays, Kansas, 67601
- Hutchinson Hospital Corporation, Hutchinson, Kansas, 67502
- Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, 67401
- St. Francis Comprehensive Cancer Center, Topeka, Kansas, 66606
- Mount Carmel Regional Cancer Center, Pittsburg, Kansas, 66762
- Kansas City Cancer Centers - West, Kansas City, Kansas, 66112
- Kansas City Cancer Centers - Southwest, Overland Park, Kansas, 66210
- Kansas City Cancer Center - Shawnee Mission, Shawnee Mission, Kansas, 66204
-
Oklahoma
- Cancer Centers of Southwest Oklahoma, LLC - Lawton, Lawton, Oklahoma, 73505
- Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, 73104
-
Nebraska
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center, Grand Island, Nebraska, 68803
- Cancer Resource Center - Lincoln, Lincoln, Nebraska, 68510
- Lakeside Hospital, Omaha, Nebraska, 68130
- Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, 68124
- Methodist Estabrook Cancer Center, Omaha, Nebraska, 68114
- Immanuel Medical Center, Omaha, Nebraska, 68122
- CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106
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Missouri
- St. John's Regional Medical Center, Joplin, Missouri, 64804
- Kansas City Cancer Centers - North, Kansas City, Missouri, 64154
- Kansas City Cancer Centers - South, Kansas City, Missouri, 64131
- Truman Medical Center - Hospital Hill, Kansas City, Missouri, 64108
- Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, 64128
- Kansas City Cancer Centers - East, Lee's Summit, Missouri, 64064
- Central Care Cancer Center at Carrie J. Babb Cancer Center, Bolivar, Missouri, 65613
- Skaggs Cancer Center at Skaggs Regional Medical Center, Branson, Missouri, 65616
- St. John's Regional Health Center, Springfield, Missouri, 65804
- CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65804
- Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, 63110
-
Arkansas
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center, Fort Smith, Arkansas, 72903
- NEA Medical Clinic - East Matthews, Jonesboro, Arkansas, 72401
-
Louisiana
- Highland Clinic, Shreveport, Louisiana, 71105
- Louisiana State University Health Sciences Center - Monroe, Monroe, Louisiana, 71210
- CHRISTUS Cabrini Cancer Center, Alexandria, Louisiana, 71301
- Ochsner Health Center - Bluebonnet, Baton Rouge, Louisiana, 70809
- Ochsner Health Center - Covington, Covington, Louisiana, 70433
- CCOP - Ochsner, New Orleans, Louisiana, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, 70121
-
Minnesota
- Immanuel St. Joseph's, Mankato, Minnesota, 56002
- St. Joseph's Medical Center, Brainerd, Minnesota, 56401
- Mayo Clinic Cancer Center, Rochester, Minnesota, 55905
- Miller - Dwan Medical Center, Duluth, Minnesota, 55805
- CCOP - Duluth, Duluth, Minnesota, 55805
- St. Luke's Hospital Cancer Care Center, Duluth, Minnesota, 55805
-
Iowa
- Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, 50401
- McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, 52501
- Covenant Cancer Treatment Center, Waterloo, Iowa, 50702
- Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, 52722
-
Wisconsin
- Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin, 54601
- Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, 54701
- Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, 54868
- Marshfield Clinic - Chippewa Center, Chippewa Falls, Wisconsin, 54729
- Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, 54449
- Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, 54494
- Mercy Regional Cancer Center, Janesville, Wisconsin, 53547
- Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin, 54481
- Diagnostic and Treatment Center, Weston, Wisconsin, 54476
- Marshfield Clinic - Weston Center, Weston, Wisconsin, 54476
- UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, 53038
- Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, 54548
- Regional Cancer Center at Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, 53066
- Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, 54501
- D.N. Greenwald Center, Mukwonago, Wisconsin, 53149
- Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, 54904
- Waukesha Memorial Hospital Regional Cancer Center, Waukesha, Wisconsin, 53188
- Wheaton Franciscan Cancer Care - St. Joseph, Milwaukee, Wisconsin, 53210
- Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, 53097
- Columbia-Saint Mary's Cancer Care Center, Milwaukee, Wisconsin, 53211
- Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, 54303
- St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, 54303
- Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, 54154
- Bellin Memorial Hospital, Green Bay, Wisconsin, 54301
- St. Nicholas Hospital, Sheboygan, Wisconsin, 53081
- Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, 54143
- Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, 54235
-
Illinois
- Leonard C. Ferguson Cancer Center, Freeport, Illinois, 61032
- Illinois CancerCare - Bloomington, Bloomington, Illinois, 61701
- Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford, Illinois, 61108
- Sherman Hospital, Elgin, Illinois, 60123
- Rush-Copley Cancer Care Center, Aurora, Illinois, 60504
- Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, 60435
- Hematology Oncology Consultants - Naperville, Naperville, Illinois, 60540
- Provena St. Mary's Regional Cancer Center - Kankakee, Kankakee, Illinois, 60901
- Elmhurst Memorial Hospital, Elmhurst, Illinois, 60126
- North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, 60048
- Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141
- West Suburban Center for Cancer Care, River Forest, Illinois, 60305
- Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, 60714
- Kellogg Cancer Care Center, Highland Park, Illinois, 60035
- Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, 60426
- Hematology Oncology Associates - Skokie, Skokie, Illinois, 60076
- St. Francis Hospital, Evanston, Illinois, 60202
- Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center, Chicago, Illinois, 60657
- Saint Joseph Hospital, Chicago, Illinois, 60657
- Hematology and Oncology Associates, Chicago, Illinois, 60611
-
Mississippi
- Keesler Air Force Base Medical Center, Kessler AFB, Mississippi, 39534
- Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, 39581
-
Indiana
- Community Hospital, Munster, Indiana, 46321
- Clarian Arnett Cancer Care, Lafayette, Indiana, 47904
- Michiana Hematology Oncology PC - La Porte, Westville, Indiana, 46391
- Saint Anthony Memorial Health Centers, Michigan City, Indiana, 46360
- Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, 46350
- Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, 46563
- Veterans Affairs Medical Center - Indianapolis, Indianapolis, Indiana, 46202
- William N. Wishard Memorial Hospital, Indianapolis, Indiana, 46202
- St. Francis Hospital Cancer Care Services, Indianapolis, Indiana, 46237
- Howard Community Hospital, Kokomo, Indiana, 46904
- Memorial Hospital of South Bend, South Bend, Indiana, 46601
- CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601
- Central Indiana Cancer Centers - East, Indianapolis, Indiana, 46219
- Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, 46514
- Elkhart General Hospital, Elkhart, Indiana, 46515
- Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, 46845
-
Kentucky
- Mitchell Memorial Cancer Center at Owensboro Medical Health System, Owensboro, Kentucky, 42303
- Baptist Hospital East - Louisville, Louisville, Kentucky, 40207
-
Alabama
- University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, 36604
-
Tennessee
- Sarah Cannon Cancer Center at Centennial Medical Center, Nashville, Tennessee, 37203
- Tennessee Oncology, PLLC at Sarah Cannon Cancer Center, Nashville, Tennessee, 37203
-
Michigan
- Dickinson County Healthcare System, Iron Mountain, Michigan, 49801
- Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, 49085
- Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, 49085
- Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, 49431
-
Ohio
- Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267
- Charles F. Kettering Memorial Hospital, Kettering, Ohio, 45429
-
Georgia
- Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, 30033
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