A Phase II Trial of 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) Chemotherapy Plus Bevacizumab for Patients With Unresectable Stage IV Colon Cancer and a Synchronous Asymptomatic Primary Tumor
OBJECTIVES:
Primary
- Determine the rate of major morbidity in patients with unresectable stage IV colon
cancer and a synchronous asymptomatic primary tumor treated with fluorouracil,
leucovorin calcium, and oxaliplatin (mFOLFOX6) in combination with bevacizumab without
resection of the primary tumor.
Secondary
- Determine the rate of specific events related to the intact primary tumor requiring
hospitalization or a major intervention but not requiring surgery.
- Determine the rate of ≥ grade 3 toxicity as defined by the Common Terminology Criteria
for Adverse Events version 3.0 (CTCAE v3.0) that is related to study therapy prior to
disease progression.
- Determine overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV given concurrently with
leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours
on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years after
study entry.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Major Morbidity Related to the Intact Primary Tumor
Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.
24 months
No
Norman Wolmark, MD
Principal Investigator
NSABP Foundation, Inc.
United States: Federal Government
NSABP C-10
NCT00321828
March 2006
December 2012
Name | Location |
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CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco, California 94115 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Sibley Memorial Hospital | Washington, District of Columbia 20016 |
Southwest Medical Center | Liberal, Kansas 67901 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
St. Barnabas Medical Center Cancer Center | Livingston, New Jersey 07039 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Kaiser Permanente Medical Center - Sacramento | Sacramento, California 95825 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
Kaiser Permanente - Fremont | Fremont, California 94538 |
Kaiser Permanente Medical Center - Hayward | Hayward, California 94545 |
Kaiser Permanente Medical Center - Redwood City | Redwood City, California 94063 |
Kaiser Permanente Medical Center - Richmond | Richmond, California 94801 |
Kaiser Permanente Medical Center - Roseville | Roseville, California 95661 |
South Sacramento Kaiser-Permanente Medical Center | Sacramento, California 95823 |
Kaiser Permanente Medical Office -Vandever Medical Office | San Diego, California 92120 |
Kaiser Permanente Medical Center - Santa Teresa | San Jose, California 95119 |
Kaiser Foundation Hospital - San Rafael | San Rafael, California 94903 |
Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa, California 95403 |
Kaiser Permanente Medical Center - South San Francisco | South San Francisco, California 94080 |
Kaiser Permanente Medical Facility - Stockton | Stockton, California 95210 |
Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek, California 94596 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Mercy Medical Center | Springfield, Ohio 45504 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis, Missouri 63141 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Wayne Hospital | Greenville, Ohio 45331 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton, Pennsylvania 18510 |
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Louisville Oncology at Norton Cancer Institute - Louisville | Louisville, Kentucky 40202 |
Scripps Cancer Center - San Diego | San Diego, California 92121 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Riddle Memorial Hospital Cancer Center | Media, Pennsylvania 19063 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center | Upland, Pennsylvania 19013 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Cancer Institute at St. Joseph Medical Center | Towson, Maryland 21204 |
Oncology Hematology Care, Incorporated - Blue Ash | Cincinnati, Ohio 45242 |