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Last Modified: 4/24/2009     First Published: 11/22/2004  
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Drug Information from MedlinePlus
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCIECOG-E4203
E4203, NCT00098787

Special Category: NCI Web site featured trial, NCI - CMS pilot project trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, 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 colorectal cancer by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment.

This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating patients with metastatic or recurrent colorectal cancer.

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed in one of three treatment groups).

Patients in group one will receive a 30-90 minute infusion of bevacizumab, a 2-hour infusion of oxaliplatin, and a 90-minute infusion of irinotecan in weeks 1 and 3.

Patients in groups two and three will receive bevacizumab and oxaliplatin as in group one, a 2-hour infusion of leucovorin, and a 2-day continuous infusion of fluorouracil in weeks 1 and 3.

In all groups, treatment may repeat every 4 weeks for as long as benefit is shown.

Patients will be evaluated periodically for 4 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Neal Meropol, MD, Protocol chair
Ph: 215-728-2450; 888-369-2427
Jean Grem, MD, Protocol co-chair
Ph: 402-559-6210

Trial Sites

U.S.A.
Colorado
  Aurora
 Aurora Presbyterian Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Boulder
 Boulder Community Hospital
 Clinical Trials Office - Boulder Community Hospital
Ph: 303-938-5253
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Clinical Trials Office - Penrose Cancer Center
Ph: 719-776-5275
  Denver
 CCOP - Colorado Cancer Research Program
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Porter Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Presbyterian - St. Luke's Medical Center
 Clinical Trials Office - Presbyterian - St. Luke's Medical Center
Ph: 303-839-6000
 Rose Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Anthony Central Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Joseph Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Englewood
 Swedish Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Grand Junction
 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Greeley
 North Colorado Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Lone Tree
 Sky Ridge Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Loveland
 McKee Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Thornton
 North Suburban Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Wheat Ridge
 Exempla Lutheran Medical Center
 Clinical Trials Office - Exempla Lutheran Medical Center
Ph: 303-403-3605
Florida
  Gainesville
 University of Florida Shands Cancer Center
 Clinical Trials Office - University of Florida Shands Cancer Center
Ph: 888-254-7581
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3019
  Berwyn
 Hematology Oncology Associates of Illinois - Berwyn
 Mary Mulcahy, MD
Ph: 312-695-6180
  Chicago
 Hematology and Oncology Associates
 Clinical Trails Office - Hematology and Oncology Associates
Ph: 312-695-1301
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Ph: 312-695-1301
 Email: cancer@northwestern.edu
 Saint Joseph Hospital
 Mary Mulcahy, MD
Ph: 312-695-6180
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3019
 Midwest Center for Hematology/Oncology
 Mary Mulcahy, MD
Ph: 312-695-6180
  Libertyville
 North Shore Oncology and Hematology Associates, Limited - Libertyville
 Mary Mulcahy, MD
Ph: 312-695-6180
  Naperville
 La Grange Oncology Associates - Geneva
 Mary Mulcahy, MD
Ph: 312-695-6180
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Mary Mulcahy, MD
Ph: 312-695-6180
  Rockford
 Swedish-American Regional Cancer Center
 Clinical Trials Office - Swedish-American Regional Cancer Center
Ph: 815-489-4413
  Skokie
 Hematology Oncology Associates - Skokie
 Mary Mulcahy, MD
Ph: 312-695-6180
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart General Hospital
 Bilal Ansari, MD
Ph: 269-983-8260
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
 Veterans Affairs Medical Center - Indianapolis
 Patrick Loehrer, MD
Ph: 317-278-7418
 William N. Wishard Memorial Hospital
 Patrick Loehrer, MD
Ph: 317-278-7418
  Kokomo
 Howard Community Hospital
 Bilal Ansari, MD
Ph: 269-983-8260
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Bilal Ansari, MD
Ph: 269-983-8260
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3019
  South Bend
 CCOP - Northern Indiana CR Consortium
 Bilal Ansari, MD
Ph: 269-983-8260
 Memorial Hospital of South Bend
 Clinical Trials Office - Memorial Hospital of South Bend
Ph: 800-284-7370
 Saint Joseph Regional Medical Center
 Bilal Ansari, MD
Ph: 269-983-8260
Iowa
  Des Moines
 CCOP - Iowa Oncology Research Association
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital
Ph: 515-241-8704
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Capitol Hospital
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
  Ottumwa
 McCreery Cancer Center at Ottumwa Regional
 Robert Behrens
Ph: 641-684-2946
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Wender, MD, PhD
Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Wender, MD, PhD
Ph: 712-252-0088
Massachusetts
  Taunton
 Morton Hospital & Medical Center
 Robert McNamee, MD
Ph: 508-824-5865
Michigan
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7458
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Bilal Ansari, MD
Ph: 269-983-8260
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Alan Berg, MD
Ph: 402-420-7000
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center
Ph: 402-398-6060
 CCOP - Missouri Valley Cancer Consortium
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 Creighton University Medical Center
 Clinical Trials Office - Creighton University Medical Center
Ph: 402-280-4100
 Immanuel Medical Center
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Ph: 800-999-5465
New Jersey
  Hamilton
 Cancer Institute of New Jersey at Hamilton
 Clinical Trials Office - Cancer Institute of New Jersey at Hamilton
Ph: 609-631-6946
  Marlton
 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
 Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Ph: 888-847-8823
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
  Voorhees
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Michael Entmacher, MD
Ph: 609-702-1900
Ohio
  Bellefontaine
 Mary Rutan Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Canton
 Aultman Cancer Center at Aultman Hospital
 Clinical Trials Office - Aultman Cancer Center at Aultman Hospital
Ph: 330-363-6891
  Chillicothe
 Adena Regional Medical Center
 Clinical Trials Office - Adena Regional Medical Center
Ph: 877-779-7585
  Columbus
 CCOP - Columbus
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
 Doctors Hospital at Ohio Health
 Clinical Trials Office - Doctors Hospital at Ohio Health
Ph: 614-566-3275
 Grant Medical Center Cancer Care
 Clinical Trials Office - Grant Medical Center Cancer Care
Ph: 614-566-4475
 Mount Carmel Health - West Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
 Riverside Methodist Hospital Cancer Care
 Clinical Trials Office - Riverside Methodist Hospital Cancer Care
Ph: 614-566-4475
  Delaware
 Grady Memorial Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Lima
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
 Mercy Medical Center
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler, MD, PhD
Ph: 614-442-3130
  Zanesville
 Genesis - Good Samaritan Hospital
 Clinical Trials Office - Genesis - Good Samaritan Hospital
Ph: 740-454-5232
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital
Ph: 215-481-2402
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Friedman, MD
Ph: 610-402-0512
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Sanjiv Agarwala, MD
Ph: 610-954-2145
  Hershey
 Penn State Cancer Institute at Milton S. Hershey Medical Center
 Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center
Ph: 717-531-3779
 Email: CTO@hmc.psu.edu
  Lewistown
 Lewistown Hospital
 Yixing Jiang
Ph: 717-242-7143
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania
Ph: 800-474-9892
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
  Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Clinical Trials Office - McGlinn Family Regional Cancer Center
Ph: 610-988-9323
  State College
 Mount Nittany Medical Center
 Yixing Jiang
Ph: 814-231-7000
  West Grove
 Jennersville Regional Hospital
 Clinical Trials Office - Jennersville Regional Hospital
Ph: 610-869-1396
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Loren Tschetter, MD
Ph: 605-328-8000
 Medical X-Ray Center, PC
 Loren Tschetter, MD
Ph: 605-328-8000
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Tennessee
  Chattanooga
 Erlanger Cancer Center at Erlanger Hospital - Baroness
 Clinical Trials Office - Erlanger Cancer Center
Ph: 423-778-6947
Texas
  Temple
 CCOP - Scott and White Hospital
 Lucas Wong, MD
Ph: 254-724-1053
Wisconsin
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Clinical Trials Office - Gundersen Lutheran Cancer Center
Ph: 608-775-2385
 Email: cancerctr@gundluth.org

Related Information

Featured trial article

Registry Information
Official Title Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer
Trial Start Date 2005-07-14
Trial Completion Date 2012-10-30 (estimated)
Registered in ClinicalTrials.gov NCT00098787
Date Submitted to PDQ 2004-10-13
Information Last Verified 2009-04-24
NCI Grant/Contract Number CA21115

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