Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Colon Mucinous Adenocarcinoma, Colon Signet Ring Cell Adenocarcinoma, Lynch Syndrome
About this trial
This is an interventional treatment trial for Colon Mucinous Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: STEP 1: INITIAL REGISTRATION The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination; colonoscopy should be performed postoperatively for those unable to have a preoperative colonoscopy to guarantee there are no synchronous lesions; (if tumor is located beyond sigmoid colon and centimeter distance unavailable, include anatomic region of colon, e.g. right colon, transverse colon, hepatic flexure descending colon, cecum etc.) Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk High-risk patients will be randomized to treatment Arms A or B Low-risk patients will be registered to Arm C for observation NOTE: Every effort should be made to submit blocks (tumor and normal mucosa) to the Principal Coordinates Analysis (PCO) immediately; blocks CANNOT be accepted after day 50 (post surgery) in order to allow for molecular assessment Specific laboratory requirements for Step 2 must be obtained within 2 weeks prior to Step 2 randomization Patients must not have synchronous tumors Patients must not have appendiceal tumors Patients must not have a history of inflammatory bowel disease (IBD) Patients with hereditary non-polyposis colorectal cancer (HNPCC) are eligible Patients must have no history of isolated, distant, or non-contiguous intra-abdominal metastases, even if restricted Patients must have histologically confirmed adenocarcinoma of the colon that meets the criteria below: Stage II adenocarcinoma (pT3/pT4a/pT4b pN0 M0 according to the definitions of the American Joint Committee on Cancer, 7th Edition, 2010): the tumor invades through the muscularis propria into pericolic tissues (pT3), penetrates to the surface of the visceral peritoneum (pT4a), or directly invades other organs or structures (pT4b); patients with mesenteric tumor deposits or satellites without identifiable residual lymph node in the absence of lymph node involvement are now designated pN1c, rather than pT3; patients with such tumor deposits are not eligible for E5202; patients must have had a complete resection (R0 resection) Patients must have >= 8 lymph nodes evaluated and reported Patients must not have presented with clinical complete obstruction or perforation of the bowel Patients must not have had any systemic or radiation therapy initiated for this malignancy Patients must not have a previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions: Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years Patients with completely excised or removed breast cancer and disease free > 5 years, regardless of the continuation of hormonal therapy Patients with previous radiation therapy (RT) to the pelvic region will be ineligible Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 STEP 2: RANDOMIZATION (HIGH RISK PATIENTS - ARMS A AND B ONLY) Within 2 weeks prior to randomization, postoperative absolute granulocyte count (AGC) must be >= 1500/mm^3 (or < 1500/mm^3, if in the opinion of the investigator, this represents an ethnic or racial variation of normal) Within 2 weeks prior to randomization, the postoperative platelet count must be >= 100,000/mm^3 Within 2 weeks prior to randomization, there must be postoperative evidence of adequate hepatic function; bilirubin must be =< upper limit of normal (ULN) unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin Within 2 weeks prior to randomization, there must be postoperative evidence of adequate hepatic function; alkaline phosphatase must be < 2.5 x ULN Within 2 weeks prior to randomization, there must be postoperative evidence of adequate hepatic function; aspartate transaminase (AST) must be < 1.5 x ULN Within 2 weeks prior to randomization, there must be postoperative evidence of adequate renal function; serum creatinine =< 1.5 x ULN Within 2 weeks prior to randomization, there must be postoperative evidence of adequate renal function; urine protein/creatinine (UPC) ratio of < 1.0; patients with a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1 gm of protein in order to participate Patients with any significant bleeding that is not related to the primary colon tumor within 6 months prior to study entry are not eligible Patients with gastroduodenal ulcer(s) determined to be active by endoscopy are not eligible Patients with a history of hypertension must measure < 150/90 mmHg and be on a stable regimen of anti-hypertensive therapy Patients must not have a serious or non-healing wound, skin ulcers or bone fracture Patients experiencing clinically significant peripheral neuropathy at the time of step 2 randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE 4.0] as grade 2 or greater neurosensory or neuromotor toxicity) are not eligible Patients must not have had invasive procedures, defined as follows: Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomization Or anticipate the need for major surgical procedure(s) during the course of the study Patients must begin adjuvant treatment no less than 28 days and no more than 60 days from surgery Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 3 months after the completion of bevacizumab; women must not be pregnant or breast-feeding; all females of childbearing potential must have a serum pregnancy test to rule out pregnancy within 2 weeks prior to step 2 randomization Patients with prothrombin time (PT) (international normalized ratio [INR]) > 1.5 are not eligible, unless the patient is on full-dose anticoagulants; if so, the following criteria must be met for enrollment: The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on a stable dose of low molecular weight heparin The subject must not have active bleeding or a pathological condition that is associated with a high risk of bleeding Patients with non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs are not eligible; specifically excluded are the following conditions: New York Heart Association (NYHA) class III or IV congestive heart failure Current symptomatic arrhythmia Any non-malignant systemic disease Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible Patients with a history of the following within twelve months of study entry are not eligible: Arterial thromboembolic events Unstable angina Myocardial infarction Patients with symptomatic peripheral vascular disease are not eligible Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible Patients must not have a known allergy to platinum compounds STEP 2: REGISTRATION (LOW-RISK PATIENTS - ARM C) Patients determined to be low risk are eligible
Sites / Locations
- Northeast Alabama Regional Medical Center
- University of Alabama at Birmingham Cancer Center
- Clearview Cancer Institute
- Mobile Infirmary Medical Center
- Providence Hospital
- Providence Alaska Medical Center
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- Mercy Hospital Fort Smith
- NEA Baptist Memorial Hospital
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- John Muir Medical Center-Concord Campus
- City of Hope Comprehensive Cancer Center
- Bay Area Breast Surgeons Inc
- Valley Medical Oncology Consultants-Fremont
- Washington Hospital
- Saint Jude Medical Center
- Glendale Memorial Hospital and Health Center
- Marin Cancer Care Inc
- Marin General Hospital
- Saint Rose Hospital
- Loma Linda University Medical Center
- Veterans Affairs Loma Linda Healthcare System
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Providence Holy Cross Medical Center
- Memorial Medical Center
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Saint Joseph Hospital - Orange
- Desert Regional Medical Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Eisenhower Medical Center
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Salinas Valley Memorial
- UC San Diego Medical Center - Hillcrest
- Kaiser Permanente-San Diego Mission
- Sharp Memorial Hospital
- San Diego VA Medical Center
- Zuckerberg San Francisco General Hospital
- California Pacific Medical Center-Pacific Campus
- UCSF Medical Center-Mount Zion
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Providence Santa Rosa Memorial Hospital
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Northbay Cancer Center
- Sutter Solano Medical Center/Cancer Center
- John Muir Medical Center-Walnut Creek
- The Medical Center of Aurora
- Rocky Mountain Regional VA Medical Center
- UCHealth University of Colorado Hospital
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- UCHealth Memorial Hospital Central
- Denver Health Medical Center
- Porter Adventist Hospital
- University of Colorado
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Western States Cancer Research NCORP
- Shaw Cancer Center
- Swedish Medical Center
- Poudre Valley Hospital
- Valley View Hospital Cancer Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Montrose Memorial Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Bridgeport Hospital
- Danbury Hospital
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- The Hospital of Central Connecticut
- Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Stamford Hospital/Bennett Cancer Center
- Bayhealth Hospital Kent Campus
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- MedStar Georgetown University Hospital
- Sibley Memorial Hospital
- Howard University Hospital
- Boca Raton Regional Hospital
- Broward Health North
- Holy Cross Hospital
- Broward Health Medical Center
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Baptist MD Anderson Cancer Center
- Mayo Clinic in Florida
- Jupiter Medical Center
- Lakeland Regional Health Hollis Cancer Center
- Cancer Centers of Central Florida PA
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- 21st Century Oncology-Orange Park
- AdventHealth Orlando
- Cleveland Clinic-Weston
- Phoebe Putney Memorial Hospital
- University Cancer and Blood Center LLC
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Atlanta Regional CCOP
- Emory Saint Joseph's Hospital
- Northside Hospital
- Augusta Oncology Associates PC-D'Antignac
- Augusta University Medical Center
- WellStar Cobb Hospital
- John B Amos Cancer Center
- Atlanta VA Medical Center
- Dekalb Medical Center
- Northeast Georgia Medical Center-Gainesville
- Northside Hospital - Gwinnett
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- South Georgia Medical Center/Pearlman Cancer Center
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Luke's Cancer Institute - Boise
- Portneuf Medical Center
- Kootenai Clinic Cancer Services - Post Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Mount Sinai Hospital Medical Center
- Hematology and Oncology Associates
- Northwestern University
- Jesse Brown Veterans Affairs Medical Center
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Illinois
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Advocate Illinois Masonic Medical Center
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Advocate Good Samaritan Hospital
- Advocate Sherman Hospital
- Elmhurst Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Saint Francis Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Cottage
- Illinois CancerCare-Galesburg
- LaGrange Oncology Associates
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Illinois CancerCare-Havana
- Mason District Hospital
- Edward Hines Jr VA Hospital
- Hinsdale Hematology Oncology Associates Incorporated
- Hopedale Medical Complex - Hospital
- Midwest Center for Hematology Oncology
- Duly Health and Care Joliet
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Kewanee Hospital
- AMITA Health Adventist Medical Center
- AMG Libertyville - Oncology
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- DuPage Medical Group-Ogden
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Franciscan St. James Health-Olympia Fields Campus
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Swedish American Hospital
- OSF Saint Anthony Medical Center
- Edward H Kaplan MD and Associates
- Hematology Oncology Associates of Illinois - Skokie
- Midwest Cancer Research Group Incorporated
- Illinois CancerCare-Spring Valley
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Northwestern Medicine Cancer Center Warrenville
- Northwestern Medicine Central DuPage Hospital
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Indiana University/Melvin and Bren Simon Cancer Center
- Richard L. Roudebush Veterans Affairs Medical Center
- Sidney and Lois Eskenazi Hospital
- Franciscan Health Indianapolis
- Ascension Saint Vincent Indianapolis Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- IU Health Arnett Cancer Care
- Franciscan Saint Anthony Health-Michigan City
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- McFarland Clinic - Ames
- Constantinou, Costas L MD (UIA Investigator)
- University of Iowa Healthcare Cancer Services Quad Cities
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Genesis Medical Center - East Campus
- Genesis Cancer Care Institute
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- HaysMed University of Kansas Health System
- Hutchinson Regional Medical Center
- Cancer Center of Kansas-Independence
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Olathe Cancer Center
- Cancer Center of Kansas - Parsons
- Ascension Via Christi - Pittsburg
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Our Lady Bellefonte Hospital
- Baptist Health Lexington
- The James Graham Brown Cancer Center at University of Louisville
- Baptist Health Madisonville/Merle Mahr Cancer Center
- Baton Rouge General Medical Center
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Ochsner Health Center-Covington
- DeSoto Regional Health System
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Highland Clinic
- Saint Mary's Regional Medical Center
- Maine Center for Cancer Medicine-Scarborough
- Maine Medical Center- Scarborough Campus
- York Hospital
- Anne Arundel Medical Center
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Saint Agnes Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Suburban Hospital
- University of Maryland Shore Medical Center at Easton
- Christiana Care - Union Hospital
- Frederick Memorial Hospital
- Meritus Medical Center
- UM Saint Joseph Medical Center
- Massachusetts General Hospital Cancer Center
- Beth Israel Deaconess Medical Center
- Steward Saint Elizabeth's Medical Center
- Commonwealth Hematology Oncology PC-Concord
- Dana Farber Community Cancer Care-Haverhill
- Saints Memorial Medical Center
- Lawrence Memorial
- Dana Farber-Merrimack Valley
- Holy Family Hospital
- Norwood Hospital
- Dana Farber Community Cancer Care-Quincy
- Dana Farber Community Cancer Care-Stoneham
- Morton Hospital and Medical Center
- Dana Farber Community Cancer Care-Weymouth
- Commonwealth Hematology Oncology PC-Worcester
- Reliant Medical Group Inc
- UMass Memorial Medical Center - University Campus
- Bixby Medical Center
- Hickman Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- Spectrum Health Big Rapids Hospital
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John Hospital
- Michigan State University Clinical Center
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Cancer Research Consortium of West Michigan NCORP
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Holland Community Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Sparrow Hospital
- Lapeer Regional Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- McLaren Cancer Institute-Macomb
- Mercy Health Partners-Hackley Campus
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Oncology Care Associates PLLC
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- University of Michigan Health - West
- Medini, Eitan MD (UIA Investigator)
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Etzell, Paul S MD (UIA Investigator)
- Lake Region Healthcare Corporation-Cancer Care
- Swenson, Wade II, MD (UIA Investigator)
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Mayo Clinic Health Systems-Mankato
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- Minneapolis VA Medical Center
- University of Minnesota/Masonic Cancer Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Woodwinds Health Campus
- Hattiesburg Clinic - Hematology/Oncology Clinic
- Hematology and Oncology Clinic
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- Southeast Missouri Hospital
- Saint Francis Medical Center
- Saint Luke's Hospital
- Missouri Cancer Associates
- Veterans Administration
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Freeman Health System
- SSM Health Saint Louis University Hospital
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Deaconess Medical Center
- Bozeman Deaconess Hospital
- Internal Medicine of Bozeman
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Guardian Oncology and Center for Wellness
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Cancer Research Center
- Cancer Alliance of Nebraska
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Creighton University Medical Center
- University of Nebraska Medical Center
- Carson-Tahoe Specialty Medical Center
- University Medical Center of Southern Nevada
- Nevada Cancer Institute-Summerlin Campus
- Nevada Cancer Research Foundation NCORP
- Renown Regional Medical Center
- New Hampshire Oncology Hematology PA-Concord
- LRGHealthcare-Lakes Region General Hospital
- Elliot Hospital
- Solinsky Center for Cancer Care
- Portsmouth Regional Hospital
- Ocean University Medical Center
- Cooper Hospital University Medical Center
- Veterans Adminstration New Jersey Health Care System
- John F Kennedy Medical Center
- AtlantiCare Surgery Center
- Hunterdon Medical Center
- CentraState Medical Center
- Hackensack University Medical Center
- The Cancer Institute of New Jersey Hamilton
- Saint Barnabas Medical Center
- Mountainside Hospital
- Morristown Medical Center
- Virtua Memorial
- Jersey Shore Medical Center
- Saint Peter's University Hospital
- Rutgers Cancer Institute of New Jersey
- Rutgers New Jersey Medical School
- Saint Luke's Hospital-Warren Campus
- AtlantiCare Regional Medical Center -Main Campus
- Riverview Medical Center/Booker Cancer Center
- Valley Hospital
- Robert Wood Johnson University Hospital Somerset
- Sparta Cancer Treatment Center
- Overlook Hospital
- Community Medical Center
- Saint Francis Medical Center
- Inspira Medical Center Vineland
- Virtua Voorhees
- Lincoln Medical and Mental Health Center
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center-Wakefield Campus
- Montefiore Medical Center - Moses Campus
- Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- Finger Lakes Hematology and Oncology
- Mary Imogene Bassett Hospital
- Garnet Health Medical Center
- NYU Winthrop Hospital
- Mount Sinai Union Square
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Mount Sinai West
- NYP/Weill Cornell Medical Center
- Nyack Hospital
- Rochester General Hospital
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Staten Island University Hospital
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Syracuse Veterans Administration Medical Center
- Faxton-Saint Luke's Healthcare
- Randolph Hospital
- Mission Hospital
- Cone Health Cancer Center at Alamance Regional
- Waverly Hematology Oncology
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Cone Health Cancer Center
- East Carolina University
- Maria Parham Hospital
- Lenoir Memorial Hospital
- Vidant Oncology-Kinston
- Southeastern Regional Medical Center
- Granville Medical Center
- UNC Rex Healthcare
- Duke Raleigh Hospital
- Annie Penn Memorial Hospital
- Person Memorial Hospital
- Rutherford Hospital
- Iredell Memorial Hospital
- Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- Wilson Medical Center
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Altru Cancer Center
- Trinity Cancer Care Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Summa Health System - Barberton Campus
- Mary Rutan Hospital
- Toledo Clinic Cancer Centers-Bowling Green
- Cleveland Clinic Mercy Hospital
- Aultman Health Foundation
- Adena Regional Medical Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Foundation
- North Coast Cancer Care-Clyde
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton Veterans Affairs Medical Center
- Dayton NCI Community Oncology Research Program
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Fremont Memorial Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Cole, Sharon, K. M.D. (UIA Investigator)
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Lima Memorial Hospital
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Knox Community Hospital
- Licking Memorial Hospital
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Stark, Michael, Edward. M.D. (UIA Investigator)
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Cancer Care Associates
- Integris Cancer Institute of Oklahoma
- Saint John Medical Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Saint Charles Health System
- Bay Area Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Adventist Medical Center
- Providence Saint Vincent Medical Center
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science University
- Salem Hospital
- Legacy Meridian Park Hospital
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Bryn Mawr Hospital
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Doylestown Hospital
- Delaware County Memorial Hospital
- Oncology Hematology Associates of Northern Pennsylvania
- Pocono Medical Center
- Easton Hospital
- Ephrata Cancer Center
- UPMC Hillman Cancer Center Erie
- UPMC Hamot
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Armstrong Center for Medicine and Health
- Lancaster General Hospital
- Saint Mary Medical and Regional Cancer Center
- Lewistown Hospital
- Riddle Memorial Hospital
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Jefferson Torresdale Hospital
- Chestnut Hill Health System
- Einstein Medical Center Philadelphia
- Phoenixville Hospital
- Allegheny General Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Pottstown Hospital
- Guthrie Medical Group PC-Robert Packer Hospital
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Scranton Hematology Oncology
- Grand View Hospital
- Geisinger Medical Group
- Mount Nittany Medical Center
- Associates In Hematology Oncology PC-Upland
- Chester County Hospital
- Jennersville Regional Hospital
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- Lankenau Medical Center
- Main Line Health NCORP
- WellSpan Health-York Hospital
- Hematology and Oncology Associates of Rhode Island Inc
- Roger Williams Medical Center
- Kent Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- Beaufort Memorial Hospital
- Prisma Health Cancer Institute - Spartanburg
- Roper Hospital
- Prisma Health Cancer Institute - Easley
- Tidelands Georgetown Memorial Hospital
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Avera McKennan Hospital and University Health Center
- Sanford USD Medical Center - Sioux Falls
- Erlanger Medical Center
- Vanderbilt-Ingram Cancer Center Cool Springs
- Jones Clinic
- Wellmont Holston Valley Hospital and Medical Center
- Tennessee Cancer Specialists-Dowell Springs
- Thompson Cancer Survival Center
- East Tennessee Baptist Hospital-Mercy Health Partners
- University of Tennessee - Knoxville
- Nashville Oncology Associates PC
- Meharry Medical College
- Vanderbilt University/Ingram Cancer Center
- The Don and Sybil Harrington Cancer Center
- Texas Oncology-Austin Midtown
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology-Austin North
- Texas Oncology Seton Northwest
- Texas Oncology-Cedar Park
- Medical City Dallas Hospital
- Parkland Memorial Hospital
- Clements University Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Baylor Saint Luke's Medical Center
- Ben Taub General Hospital
- Houston Methodist Hospital
- M D Anderson Cancer Center
- Michael E DeBakey VA Medical Center
- Wilford Hall Medical Center
- Doctor's Hospital of Laredo
- Texas Oncology-Seton Williamson
- Texas Oncology - Round Rock Cancer Center
- Audie L Murphy VA Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- Texas Oncology- San Marcos
- Scott and White Memorial Hospital
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Southwestern Vermont Medical Center
- Mount Ascutney Hospital and Health Center
- Sentara Martha Jefferson Hospital
- University of Virginia Cancer Center
- Danville Regional Medical Center
- Fredericksburg Oncology Inc
- Virginia Oncology Associates-Hampton
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Peninsula Cancer Institute-Newport News
- Southwest VA Regional Cancer Center
- MultiCare Auburn Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Kadlec Clinic Hematology and Oncology
- Saint Clare Hospital
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Minor and James Medical PLLC
- VA Puget Sound Health Care System
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- Cancer Care Northwest - Spokane South
- Providence Sacred Heart Medical Center and Children's Hospital
- Providence Holy Family Hospital
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- Madigan Army Medical Center
- PeaceHealth Southwest Medical Center
- Wenatchee Valley Hospital and Clinics
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia University Charleston Division
- Edwards Comprehensive Cancer Center
- Marshall University Medical Center
- Saint Mary's Medical Center
- West Virginia University Healthcare
- Camden Clark Medical Center
- Princeton Community Hospital
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Saint Agnes Hospital/Agnesian Cancer Center
- Aurora Cancer Care-Franklin
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Glendale
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Mercyhealth Hospital and Cancer Center - Janesville
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Mayo Clinic Health System-Franciscan Healthcare
- UW Health Oncology-One South Park
- Dean Hematology and Oncology Clinic
- University of Wisconsin Carbone Cancer Center
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension All Saints Hospital
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Vince Lombardi Cancer Clinic - Slinger
- Ascension Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center
- Cross Cancer Institute
- BCCA-Vancouver Cancer Centre
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- London Regional Cancer Program
- Lakeridge Health Oshawa
- Ottawa Hospital and Cancer Center-General Campus
- Health Sciences North
- Thunder Bay Regional Health Science Centre
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- Saint Michael's Hospital
- PEI Cancer Treatment Centre-Queen Elizabeth Hospital
- Allan Blair Cancer Centre
- Instituto Nacional de Enfermedades Neoplasicas
- Andres Grillasca Hospital
- San Juan Community Oncology Group
- San Juan Veterans Affairs Medical Center
- San Juan City Hospital
- University Of Pretoria
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
No Intervention
Arm A (oxaliplatin, leucovorin calcium, fluorouracil)
Arm B (combination chemotherapy, bevacizumab)
Arm C (observation)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
Patients undergo observation.