Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A total of 117-246 patients (40-72 in arm I, 40-72 in arm II, 37-102 in arm III) will be accrued for this study within 14-23 months.
Response rate (complete response [CR] and partial response [PR]) as measured by RECIST
Progression-free survival as measured by time to event at 1 year after closure to accrual
Overall survival as measured by time to event at 1 year after closure to accrual
Toxicity as measured by NCI CTCAE v3.0 at 1 year after closure to accrual
This is a randomized, multicenter study. Patients are stratified according to thymidylate synthase (TS) expression levels (high vs low or indeterminate). Patients with high TS expression are randomized to 1 of 2 treatment arms (arms I or II). Patients with low or indeterminate TS expression are assigned to arm III.
In all arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Patients are followed for 4 years from the date of study registration.
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U.S.A. |
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Illinois |
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Aurora |
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| Rush-Copley Cancer Care Center |
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| Kendrith Rowland, MD | |
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Chicago |
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| Rush University Medical Center |
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| Clinical Trials Office - Rush University Medical Center | |
| Email:
clinical_trials@rush.edu |
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Joliet |
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| Joliet Oncology-Hematology Associates, Limited - West |
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| Kendrith Rowland, MD | |
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Rockford |
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| Swedish-American Regional Cancer Center |
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| Clinical Trials Office - Swedish-American Regional Cancer Center | |
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Springfield |
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| Regional Cancer Center at Memorial Medical Center |
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| Clinical Trials Office - Regional Cancer Center at Memorial Medical Center | |
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Urbana |
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| Carle Cancer Center at Carle Foundation Hospital |
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| Clinical Trials Office - Carle Cancer Center | |
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| CCOP - Carle Cancer Center |
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| Clinical Trials Office - CCOP - Carle Cancer Center | |
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Indiana |
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Elkhart |
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| Elkhart General Hospital |
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| Bilal Ansari, MD | |
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Kokomo |
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| Howard Community Hospital |
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| Bilal Ansari, MD | |
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La Porte |
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| Center for Cancer Therapy at LaPorte Hospital and Health Services |
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| Bilal Ansari, MD | |
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Michigan City |
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| Saint Anthony Memorial Health Centers |
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| Kendrith Rowland, MD | |
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South Bend |
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| CCOP - Northern Indiana CR Consortium |
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| Bilal Ansari, MD | |
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| Memorial Hospital of South Bend |
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| Clinical Trials Office - Memorial Hospital of South Bend | |
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| Saint Joseph Regional Medical Center |
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| Bilal Ansari, MD | |
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Michigan |
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Kalamazoo |
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| Bronson Methodist Hospital |
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| Raymond Lord, MD | |
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| West Michigan Cancer Center |
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| Clinical Trials Office - West Michigan Cancer Center | |
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St. Joseph |
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| Lakeland Regional Cancer Care Center - St. Joseph |
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| Bilal Ansari, MD | |
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Minnesota |
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Burnsville |
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| Fairview Ridges Hospital |
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| Patrick Flynn, MD | |
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Coon Rapids |
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| Mercy and Unity Cancer Center at Mercy Hospital |
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| Patrick Flynn, MD | |
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Edina |
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| Fairview Southdale Hospital |
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| Clinical Trials Office - Fairview Southdale Hospital | |
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Fridley |
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| Mercy and Unity Cancer Center at Unity Hospital |
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| Patrick Flynn, MD | |
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Maplewood |
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| Minnesota Oncology Hematology, PA - Maplewood |
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| Patrick Flynn, MD | |
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Minneapolis |
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| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital |
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| Clinical Trials Office - Virginia Piper Cancer Institute | |
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Robbinsdale |
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| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center |
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| Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |
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Saint Louis Park |
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| CCOP - Metro-Minnesota |
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| Patrick Flynn, MD | |
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| Park Nicollet Cancer Center |
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| Patrick Flynn, MD | |
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Saint Paul |
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| United Hospital |
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| Patrick Flynn, MD | |
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Waconia |
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| Ridgeview Medical Center |
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| Patrick Flynn, MD | |
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Woodbury |
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| Minnesota Oncology Hematology, PA - Woodbury |
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| Patrick Flynn, MD | |
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Nebraska |
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Omaha |
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| Alegant Health Cancer Center at Bergan Mercy Medical Center |
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| Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center | |
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| CCOP - Missouri Valley Cancer Consortium |
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| Gamini Soori, MD, FACP, FRCP, MBA | |
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| Creighton University Medical Center |
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| Clinical Trials Office - Creighton University Medical Center | |
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| Immanuel Medical Center |
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| Gamini Soori, MD, FACP, FRCP, MBA | |
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New Jersey |
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Hamilton |
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| Cancer Institute of New Jersey at Hamilton |
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| Clinical Trials Office - Cancer Institute of New Jersey at Hamilton | |
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New Brunswick |
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| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School |
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| Clinical Trials Office - Cancer Institute of New Jersey | |
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Ohio |
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Bellefontaine |
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| Mary Rutan Hospital |
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| J. Philip Kuebler, MD, PhD | |
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Chillicothe |
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| Adena Regional Medical Center |
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| Clinical Trials Office - Adena Regional Medical Center | |
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Columbus |
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| Doctors Hospital at Ohio Health |
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| Clinical Trials Office - Doctors Hospital at Ohio Health | |
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| Grant Medical Center Cancer Care |
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| Clinical Trials Office - Grant Medical Center Cancer Care | |
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| Mount Carmel Health - West Hospital |
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| J. Philip Kuebler, MD, PhD | |
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| Riverside Methodist Hospital Cancer Care |
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| Clinical Trials Office - Riverside Methodist Hospital Cancer Care | |
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Delaware |
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| Grady Memorial Hospital |
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| J. Philip Kuebler, MD, PhD | |
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Lancaster |
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| Fairfield Medical Center |
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| J. Philip Kuebler, MD, PhD | |
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Lima |
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| St. Rita's Medical Center |
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| Clinical Trials Office - St. Rita's Medical Center | |
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Marietta |
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| Strecker Cancer Center at Marietta Memorial Hospital |
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| J. Philip Kuebler, MD, PhD | |
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Newark |
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| Licking Memorial Cancer Care Program at Licking Memorial Hospital |
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| J. Philip Kuebler, MD, PhD | |
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Springfield |
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| Community Hospital of Springfield and Clark County |
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| J. Philip Kuebler, MD, PhD | |
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| Mercy Medical Center |
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| J. Philip Kuebler, MD, PhD | |
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Westerville |
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| Mount Carmel St. Ann's Cancer Center |
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| J. Philip Kuebler, MD, PhD | |
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Zanesville |
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| Genesis - Good Samaritan Hospital |
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| Clinical Trials Office - Genesis - Good Samaritan Hospital | |
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Pennsylvania |
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Abington |
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| Rosenfeld Cancer Center at Abington Memorial Hospital |
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| Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital | |
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Hershey |
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| Penn State Cancer Institute at Milton S. Hershey Medical Center |
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| Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Email:
CTO@hmc.psu.edu |
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Lewistown |
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| Lewistown Hospital |
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| Yixing Jiang | |
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Philadelphia |
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| Fox Chase Cancer Center - Philadelphia |
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| Clinical Trials Office - Fox Chase Cancer Center - Philadelphia | |
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State College |
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| Mount Nittany Medical Center |
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| Yixing Jiang | |
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West Grove |
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| Jennersville Regional Hospital |
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| Clinical Trials Office - Jennersville Regional Hospital | |
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