Phase
Condition
Colon Cancer; Rectal Cancer
Rectal Cancer
Colorectal Cancer
Treatment
oxaliplatin
fluorouracil
bevacizumab
Clinical Study ID
Ages 18-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the colon
No histological findings other than adenocarcinoma of the colon
If the primary colon tumor and the metastatic lesions have been identified at the same time and it is not possible to biopsy the colonic lesion, the patient will be eligible without histologic confirmation of the primary cancer of the colon as long as other radiographic studies or scans document the characteristics of a colon cancer AND the biopsy of a metastatic site confirms diagnosis of adenocarcinoma suggestive of a primary tumor of the colon
Unresected primary tumor of the colon AND radiographically confirmed metastatic colon cancer (single or multiple sites of metastases) that are not considered surgically resectable for cure by chest imaging and CT scan or MRI of the abdomen within the past 4 weeks and by endoscopy within the past 8 weeks
Asymptomatic primary tumor
No obstruction, perforation, or active bleeding requiring transfusion
Distal extent of the tumor must be ≥ 12 cm from the anal verge on endoscopy
Not a candidate for curative surgical resection of all metastatic and colon primary tumors
No evidence of Central Nervous System (CNS) metastases
No recurrent local or metastatic disease after prior adjuvant therapy
No diagnosis of rectal carcinoma
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Absolute neutrophil count ≥ 1200/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver metastases are present)
Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if liver metastases are present)
Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if liver metastases are present)
Creatinine < 1.8 mg/dL
Urine dipstick indicating 0-1+ protein
If dipstick reading is ≥ 2+, a 24-hour urine collection must demonstrate < 1 g of protein
Prothrombin Time and International Normalized Ratio (PT/INR) ≤ 1.5 unless the patient is on therapeutic doses of warfarin, in which case the following criteria must be met:
Patient must have an in-range INR (between 2 and 3) on a stable dose of warfarin
Patient must not have active bleeding or a pathologic condition that is associated with a high risk of bleeding
Patients with a history of non-colorectal malignancies must be disease free for ≥ 5 years prior to study entry and be deemed at low risk for recurrence
Patients with the following cancers are eligible if diagnosed and treated within the past 5 years:
Carcinoma in situ of the colon
Melanoma in situ
Basal cell or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after the completion of study therapy
No uncontrolled blood pressure (BP), defined as BP > 150/100 mm Hg
No nonmalignant systemic disease that would preclude any of the study therapy drugs, compromise the safety of the patient, or inhibit the patient's ability to participate in the study, including any of the following:
New York Heart Association class III or IV cardiac disease
Myocardial infarction within the past 6 months
Unstable angina within the past 6 months
Symptomatic arrhythmia
No transient ischemic attack or cerebrovascular accident within the past 6 months
No symptomatic peripheral vascular ischemia within the past 6 months
No arterial thrombotic event within the past 6 months
No gastroduodenal ulcer(s) determined by endoscopy to be active
No gastrointestinal perforation within the past 12 months
No serious or nonhealing wound, skin ulcer, or bone fracture
No significant traumatic injury within the past 28 days
No significant episodes of acute bleeding requiring blood transfusion within the past 6 months
No clinically significant (≥ grade 2) peripheral neuropathy (neurosensory or neuromotor toxicity)
No pulmonary fibrosis or interstitial pneumonitis by chest x-ray
No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting study requirements
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior systemic chemotherapy, radiation therapy, or surgery for this malignancy
No prior endoscopic management of this malignancy other than biopsy, including endoscopic stent placement, fulguration, or laser treatment
More than 30 days since prior investigational drugs
More than 28 days since prior major surgical procedure or open biopsy
More than 7 days since prior core biopsy or other minor procedure, excluding placement of a vascular access device
No concurrent major surgery unrelated to intact primary colon cancer
No concurrent radiotherapy
No concurrent filgrastim (G-CSF) or pegfilgrastim as primary prophylaxis for neutropenia
No concurrent halogenated antiviral agents
No other concurrent investigational drugs
No other concurrent antineoplastic agents
Study Design
Study Description
Connect with a study center
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
City of Hope Comprehensive Cancer Center
Duarte, California 91010-3000
United StatesSite Not Available
Kaiser Permanente - Fremont
Fremont, California 94538
United StatesSite Not Available
Kaiser Permanente Medical Center - Hayward
Hayward, California 94545
United StatesSite Not Available
Scripps Cancer Center - San Diego
La Jolla, California 92037
United StatesSite Not Available
Kaiser Permanente Medical Center - Oakland
Oakland, California 94611
United StatesSite Not Available
Kaiser Permanente Medical Center - Redwood City
Redwood City, California 94063
United StatesSite Not Available
Kaiser Permanente Medical Center - Richmond
Richmond, California 94801
United StatesSite Not Available
Kaiser Permanente Medical Center - Roseville
Roseville, California 95661
United StatesSite Not Available
Kaiser Permanente Medical Center - Sacramento
Sacramento, California 95825
United StatesSite Not Available
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California 95823
United StatesSite Not Available
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California 92120
United StatesSite Not Available
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California 94115
United StatesSite Not Available
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California 95119
United StatesSite Not Available
Kaiser Foundation Hospital - San Rafael
San Rafael, California 94903
United StatesSite Not Available
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California 95051
United StatesSite Not Available
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California 95403
United StatesSite Not Available
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California 94080
United StatesSite Not Available
Kaiser Permanente Medical Facility - Stockton
Stockton, California 95210
United StatesSite Not Available
Kaiser Permanente Medical Center - Vallejo
Vallejo, California 94589
United StatesSite Not Available
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California 94596
United StatesSite Not Available
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware 19958
United StatesSite Not Available
CCOP - Christiana Care Health Services
Newark, Delaware 19713
United StatesSite Not Available
Sibley Memorial Hospital
Washington, District of Columbia 20016
United StatesSite Not Available
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida 33805
United StatesSite Not Available
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia 31403-3089
United StatesSite Not Available
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois 60612-3785
United StatesSite Not Available
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois 62526
United StatesSite Not Available
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois 60068-1174
United StatesSite Not Available
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois 62781-0001
United StatesSite Not Available
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana 46107
United StatesSite Not Available
Elkhart General Hospital
Elkhart, Indiana 46515
United StatesSite Not Available
Howard Community Hospital
Kokomo, Indiana 46904
United StatesSite Not Available
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana 46350
United StatesSite Not Available
Reid Hospital & Health Care Services
Richmond, Indiana 47374
United StatesSite Not Available
CCOP - Northern Indiana CR Consortium
South Bend, Indiana 46601
United StatesSite Not Available
Memorial Hospital of South Bend
South Bend, Indiana 46601
United StatesSite Not Available
Saint Joseph Regional Medical Center
South Bend, Indiana 46617
United StatesSite Not Available
McFarland Clinic, PC
Ames, Iowa 50010
United StatesSite Not Available
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa 52242-1002
United StatesSite Not Available
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa 52501
United StatesSite Not Available
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas 66720
United StatesSite Not Available
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas 67801
United StatesSite Not Available
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas 67042
United StatesSite Not Available
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas 67068
United StatesSite Not Available
Lawrence Memorial Hospital
Lawrence, Kansas 66044
United StatesSite Not Available
Southwest Medical Center
Liberal, Kansas 67901
United StatesSite Not Available
Cancer Center of Kansas, PA - Newton
Newton, Kansas 67114
United StatesSite Not Available
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas 67357
United StatesSite Not Available
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas 67124
United StatesSite Not Available
Cancer Center of Kansas, PA - Salina
Salina, Kansas 67042
United StatesSite Not Available
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas 67152
United StatesSite Not Available
Associates in Womens Health, PA - North Review
Wichita, Kansas 67208
United StatesSite Not Available
CCOP - Wichita
Wichita, Kansas 67214
United StatesSite Not Available
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas 67208
United StatesSite Not Available
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas 67214
United StatesSite Not Available
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas 67214
United StatesSite Not Available
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas 67156
United StatesSite Not Available
Louisville Oncology at Norton Cancer Institute - Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland 21237
United StatesSite Not Available
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland 21921
United StatesSite Not Available
Union Hospital Cancer Program at Union Hospital
Elkton Md, Maryland 21921
United StatesSite Not Available
Cancer Institute at St. Joseph Medical Center
Towson, Maryland 21204
United StatesSite Not Available
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts 02721
United StatesSite Not Available
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Borgess Medical Center
Kalamazoo, Michigan 49001
United StatesSite Not Available
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United StatesSite Not Available
West Michigan Cancer Center
Kalamazoo, Michigan 49007-3731
United StatesSite Not Available
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan 49085
United StatesSite Not Available
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan 49085
United StatesSite Not Available
Fairview Ridges Hospital
Burnsville, Minnesota 55337
United StatesSite Not Available
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota 55433
United StatesSite Not Available
Fairview Southdale Hospital
Edina, Minnesota 55435
United StatesSite Not Available
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota 55432
United StatesSite Not Available
Hutchinson Area Health Care
Hutchinson, Minnesota 55350
United StatesSite Not Available
Meeker County Memorial Hospital
Lichfield, Minnesota 55355
United StatesSite Not Available
Meeker County Memorial Hospital
Litchfield, Minnesota 55355
United StatesSite Not Available
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota 55109
United StatesSite Not Available
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota 55109
United StatesSite Not Available
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota 55415
United StatesSite Not Available
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesSite Not Available
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota 55422-2900
United StatesSite Not Available
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota 55416
United StatesSite Not Available
Park Nicollet Cancer Center
Saint Louis Park, Minnesota 55416
United StatesSite Not Available
Regions Hospital Cancer Care Center
Saint Paul, Minnesota 55101
United StatesSite Not Available
United Hospital
Saint Paul, Minnesota 55102
United StatesSite Not Available
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota 55379
United StatesSite Not Available
Regions Hospital Cancer Care Center
St. Paul, Minnesota 55101
United StatesSite Not Available
Ridgeview Medical Center
Waconia, Minnesota 55387
United StatesSite Not Available
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota 55125
United StatesSite Not Available
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Saint Louis, Missouri 63141
United StatesSite Not Available
Missouri Baptist Cancer Center
Saint Louis, Missouri 63131
United StatesSite Not Available
CCOP - Cancer Research for the Ozarks
Springfield, Missouri 65802
United StatesSite Not Available
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri 65807
United StatesSite Not Available
St. John's Regional Health Center
Springfield, Missouri 65804
United StatesSite Not Available
CCOP - Montana Cancer Consortium
Billings, Montana 59101
United StatesSite Not Available
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana 59101
United StatesSite Not Available
Northern Rockies Radiation Oncology Center
Billings, Montana 59101
United StatesSite Not Available
St. Vincent Healthcare Cancer Care Services
Billings, Montana 59101
United StatesSite Not Available
St. James Healthcare Cancer Care
Butte, Montana 59701
United StatesSite Not Available
Great Falls Clinic - Main Facility
Great Falls, Montana 59405
United StatesSite Not Available
Great Falls, Montana 59405
United StatesSite Not Available
Glacier Oncology, PLLC
Kalispell, Montana 59901
United StatesSite Not Available
Kalispell Medical Oncology at KRMC
Kalispell, Montana 59901
United StatesSite Not Available
Kalispell Regional Medical Center
Kalispell, Montana 59901
United StatesSite Not Available
Community Medical Center
Missoula, Montana 59801
United StatesSite Not Available
Guardian Oncology and Center for Wellness
Missoula, Montana 59804
United StatesSite Not Available
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana 59807
United StatesSite Not Available
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana 59807-7877
United StatesSite Not Available
Methodist Estabrook Cancer Center
Omaha, Nebraska 68114
United StatesSite Not Available
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey 07039
United StatesSite Not Available
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey 08043
United StatesSite Not Available
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York 13057
United StatesSite Not Available
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York 12801
United StatesSite Not Available
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina 27534
United StatesSite Not Available
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina 27157-1096
United StatesSite Not Available
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio 44307
United StatesSite Not Available
Mary Rutan Hospital
Bellefontaine, Ohio 43311
United StatesSite Not Available
Aultman Cancer Center at Aultman Hospital
Canton, Ohio 44710-1799
United StatesSite Not Available
Adena Regional Medical Center
Chillicothe, Ohio 45601
United StatesSite Not Available
Oncology Hematology Care, Incorporated - Blue Ash
Cincinnati, Ohio 45242
United StatesSite Not Available
CCOP - Columbus
Columbus, Ohio 43215
United StatesSite Not Available
Doctors Hospital at Ohio Health
Columbus, Ohio 43228
United StatesSite Not Available
Grant Medical Center Cancer Care
Columbus, Ohio 43215
United StatesSite Not Available
Mount Carmel Health - West Hospital
Columbus, Ohio 43222
United StatesSite Not Available
Riverside Methodist Hospital Cancer Care
Columbus, Ohio 43214-3998
United StatesSite Not Available
CCOP - Dayton
Dayton, Ohio 45429
United StatesSite Not Available
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio 45409
United StatesSite Not Available
Good Samaritan Hospital
Dayton, Ohio 45406
United StatesSite Not Available
Grandview Hospital
Dayton, Ohio 45405
United StatesSite Not Available
Samaritan North Cancer Care Center
Dayton, Ohio 45415
United StatesSite Not Available
Veterans Affairs Medical Center - Dayton
Dayton, Ohio 45428
United StatesSite Not Available
Grady Memorial Hospital
Delaware, Ohio 43015
United StatesSite Not Available
Blanchard Valley Medical Associates
Findlay, Ohio 45840
United StatesSite Not Available
Middletown Regional Hospital
Franklin, Ohio 45005-1066
United StatesSite Not Available
Wayne Hospital
Greenville, Ohio 45331
United StatesSite Not Available
Charles F. Kettering Memorial Hospital
Kettering, Ohio 45429
United StatesSite Not Available
Fairfield Medical Center
Lancaster, Ohio 43130
United StatesSite Not Available
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio 45750
United StatesSite Not Available
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio 43055
United StatesSite Not Available
Community Hospital of Springfield and Clark County
Springfield, Ohio 45505
United StatesSite Not Available
Mercy Medical Center
Springfield, Ohio 45504
United StatesSite Not Available
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio 45373-1300
United StatesSite Not Available
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio 43081
United StatesSite Not Available
Clinton Memorial Hospital
Wilmington, Ohio 45177
United StatesSite Not Available
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio 45385
United StatesSite Not Available
Genesis - Good Samaritan Hospital
Zanesville, Ohio 43701
United StatesSite Not Available
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
United StatesSite Not Available
Riddle Memorial Hospital Cancer Center
Media, Pennsylvania 19063
United StatesSite Not Available
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania 19301-1792
United StatesSite Not Available
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania 19107-5541
United StatesSite Not Available
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania 18508
United StatesSite Not Available
Mount Nittany Medical Center
State College, Pennsylvania 16803
United StatesSite Not Available
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
Upland, Pennsylvania 19013
United StatesSite Not Available
CCOP - Main Line Health
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
CCOP - Greenville
Greenville, South Carolina 29615
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Medical X-Ray Center, PC
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota 57117-5039
United StatesSite Not Available
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas 79410-1894
United StatesSite Not Available
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont 05401
United StatesSite Not Available
Danville Regional Medical Center
Danville, Virginia 24541
United StatesSite Not Available
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia 25304
United StatesSite Not Available
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia 26102
United StatesSite Not Available
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin 54449
United StatesSite Not Available
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