Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00321828
- Lead Sponsor
- NSABP Foundation Inc
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab oxaliplatin Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab leucovorin Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
- Primary Outcome Measures
Name Time Method Major Morbidity Related to the Intact Primary Tumor 24 months 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.
- Secondary Outcome Measures
Name Time Method Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0 Time from start of study through year 5 Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration Time from start of study through year 5 Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery Time from start of study through year 5 Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery Time from start of study through year 5 Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery Time from start of study through year 5 Overall Survival as Measured by Death From Any Cause Time from start of study through year 5
Trial Locations
- Locations (162)
Kaiser Permanente Medical Center - Redwood City
🇺🇸Redwood City, California, United States
Meeker County Memorial Hospital
🇺🇸Litchfield, Minnesota, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Scripps Cancer Center - San Diego
🇺🇸La Jolla, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Medical Center - Santa Teresa
🇺🇸San Jose, California, United States
Kaiser Permanente Medical Center - Richmond
🇺🇸Richmond, California, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Riddle Memorial Hospital Cancer Center
🇺🇸Media, Pennsylvania, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
🇺🇸Upland, Pennsylvania, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
🇺🇸Scranton, Pennsylvania, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Kaiser Permanente Medical Center - Roseville
🇺🇸Roseville, California, United States
Kaiser Foundation Hospital - San Rafael
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Center - South San Francisco
🇺🇸South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton
🇺🇸Stockton, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek
🇺🇸Walnut Creek, California, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Advocate Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸Ottumwa, Iowa, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton, Maryland, United States
Cancer Institute at St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
🇺🇸Fall River, Massachusetts, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
St. Barnabas Medical Center Cancer Center
🇺🇸Livingston, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Aultman Cancer Center at Aultman Hospital
🇺🇸Canton, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Kaiser Permanente Medical Office -Vandever Medical Office
🇺🇸San Diego, California, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Oncology Hematology Care, Incorporated - Blue Ash
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
West Virginia University Health Sciences Center - Charleston
🇺🇸Charleston, West Virginia, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
South Sacramento Kaiser-Permanente Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸Sacramento, California, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Louisville Oncology at Norton Cancer Institute - Louisville
🇺🇸Louisville, Kentucky, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Kaiser Permanente Medical Center - Santa Rosa
🇺🇸Santa Rosa, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸Santa Clara, California, United States