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Clinical Trial: Phase III Study of Cetuximab, Oxaliplatin, 5-FU/LV vs. Oxaliplatin, 5-FU/LV in Patients with Previously Treated Metastatic, EGFR-Positive Colorectal Cancer
This study is currently recruiting patients.
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Purpose
The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with Oxaliplatin, 5-Fluorouracil and Leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Colorectal Cancer | Drug: cetuximab | Phase III |
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Further Study Details:
Expected Total Enrollment: 1100
Study start: March 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Documented colorectal cancer which is EGFR-positive and is metastatic.
- Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
Exclusion Criteria:
- A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
- Known dihydropyrimidine dehydogenase (DPD) deficiency.
- Known metastases in the central nervous system.
- Symptomatic sensory or peripheral neuropathy.
- More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
- Prior oxaliplatin therapy.
- Prior cetuximab or other therapy which targets the EGF pathway.
- Prior chimerized or murine monoclonal antibody therapy.
Location and Contact Information
Arkansas
Highland Oncology Group, Springdale, Arkansas, 72764, United States; Recruiting
K Davison 479-872-8130
Joseph T Beck, MD, Principal Investigator
Joseph T Beck, MD, Principal Investigator
Little Rock Hematology Oncology, Little Rock, Arkansas, 72205, United States; Recruiting
C Winters 501-907-0053
Brad P Baltz, Principal Investigator
Brad P Baltz, Principal Investigator
California
Kaiser Permanente of San Diego, San Diego, California, 92120, United States; Recruiting
S Cory 619-528-6920
Jonathan Polikoff, MD, Principal Investigator
Jonathan Polikoff, MD, Principal Investigator
South Valley Medical Plaza, Gilroy, California, 95020, United States; Recruiting
M Beck 408-847-6194
Ronald Yanagihara, MD, Principal Investigator
Ronald Yanagihara, MD, Principal Investigator
New Hope Cancer and Research Institute, Pomona, California, 91767, United States; Recruiting
C Race 909-620-5502
Herbert Duvivier, MD, Principal Investigator
Herbert Duvivier, MD, Principal Investigator
California Cancer Care, Greenbrae, California, 94904, United States; Recruiting
J Chang 415-925-5040
Peter Eisenberg, MD, Principal Investigator
Peter Eisenberg, MD, Principal Investigator
Medical Group of North County Inc, Vista, California, 92083, United States; Recruiting
D Billingsley 760-598-1700
Laurie Frakes, MD, Principal Investigator
Laurie Frakes, MD, Principal Investigator
Compassionate Cancer Care Medical Group, Fountain Valley, California, 92708, United States; Recruiting
L Skeens 714-210-2300
Haresh Jhangiani, MD, Principal Investigator
Haresh Jhangiani, MD, Principal Investigator
Medical Oncology Care Associates, Orange, California, 92868, United States; Recruiting
L Dvorak 714-541-6622
Birbal Bhaskar, MD, Principal Investigator
Birbal Bhaskar, MD, Principal Investigator
Connecticut
Medical Hematology and Oncology, Waterbury, Connecticut, 06708, United States; Recruiting
S Coatsworth 203-755-6311
Frank Alfano, MD, Principal Investigator
Frank Alfano, MD, Principal Investigator
Hematology Oncology, PC, Stamford, Connecticut, 06902, United States; Recruiting
S Murdock 203-323-8944
Salvatore Del Prete, MD, Principal Investigator
Salvatore Del Prete, MD, Principal Investigator
Norwalk Hospital, Norwalk, Connecticut, 06856, United States; Recruiting
A Skeris 203-852-2996
Richard Frank, MD, Principal Investigator
Richard Frank, MD, Principal Investigator
St. Francis Hospital and Medical Center, Hartford, Connecticut, 06105, United States; Recruiting
K Jordan 860-714-5936
Jonathan Sporn, MD, Principal Investigator
Jonathan Sporn, MD, Principal Investigator
Florida
Florida Oncology Associates, Jacksonville, Florida, 32207, United States; Recruiting
A Smith 904-388-2619
Suprith Badarinath, MD, Principal Investigator
Suprith Badarinath, MD, Principal Investigator
Hematology/Oncology of Southern Palm Beach County, Boynton Beach, Florida, 33435, United States; Recruiting
D Stefinsky 561-374-5024
Rogelio Brito, D.O., Principal Investigator
Rogelio Brito, D.O., Principal Investigator
Lake Heart and Cancer Medical Center, Leesburg, Florida, 34748, United States; Recruiting
K Magurean 352-728-2532
Lourdes Mathew, MD, Principal Investigator
Lourdes Mathew, MD, Principal Investigator
University Community Hospital, Tampa, Florida, 33613, United States; Recruiting
M Blazek 813-615-7200
Ron Schiff, MD, Principal Investigator
Ron Schiff, MD, Principal Investigator
Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States; Recruiting
J Crofton 407-303-2090
Lee Zehngebot, MD, Principal Investigator
Lee Zehngebot, MD, Principal Investigator
Georgia
Peachtree Hematology Oncology Consultants, Atlanta, Georgia, 30309, United States; Recruiting
P Searcy 404-350-9853
Charles Henderson, MD, Principal Investigator
Charles Henderson, MD, Principal Investigator
Central Georgia Hematology and Oncology, Macon, Georgia, 31201, United States; Recruiting
J Schnell 478-743-7068
Frederick Schnell, MD, Principal Investigator
Frederick Schnell, MD, Principal Investigator
Kentucky
Kentukiana Cancer Institute, Louisville, Kentucky, 40202, United States; Recruiting
M Laureano 502-561-1178
Renato LaRocca, MD, Principal Investigator
Renato LaRocca, MD, Principal Investigator
Louisiana
Medical Oncology, LLC, Baton Rouge, Louisiana, 70809, United States; Recruiting
D Bryant 225-757-0343
Michael Castine, MD, Principal Investigator
Michael Castine, MD, Principal Investigator
Maryland
Cheasapeake Oncology Hematology Associates, Baltimore, Maryland, 21225, United States; Recruiting
R Shrout 410-350-3718
Jack Hong, MD, Principal Investigator
Jack Hong, MD, Principal Investigator
Oncology Hematology Associates, Clinton, Maryland, 20735, United States; Recruiting
M Nichol 301-474-0427
Harvey Katzen, MD, Principal Investigator
Harvey Katzen, MD, Principal Investigator
Michigan
Oncology Care Associates, St. Joseph, Michigan, 49085, United States; Recruiting
K Nickel 269-985-0029
Eric Lester, MD, Principal Investigator
Eric Lester, MD, Principal Investigator
Missouri
Kansas City Oncology and Hematology Group, Kansas City, Missouri, 64131, United States; Recruiting
M Caldwell 816-823-6624
Kelly Pendergrass, MD, Principal Investigator
Kelly Pendergrass, MD, Principal Investigator
Bond Clinic, Rolla, Missouri, 65401, United States; Recruiting
R Drewel 573-364-8823
Vinay Raja, MD, Principal Investigator
Vinay Raja, MD, Principal Investigator
New Jersey
Northern New Jersey Cancer Association, Hackensack, New Jersey, 07601, United States; Recruiting
J Trobiano 201-996-5900
Andrew Jennis, MD, Principal Investigator
Andrew Jennis, MD, Principal Investigator
New York
HemOnCare, Brooklyn, New York, 11235, United States; Recruiting
L Helgesen 718-616-0801
Fakhiuddin Ahmed, MD, Principal Investigator
Fakhiuddin Ahmed, MD, Principal Investigator
Advanced Oncology Associates, Armonk, New York, 10504, United States; Recruiting
J Schwartzfield 914-273-2977
Bernard Bernhardt, MD, Principal Investigator
Bernard Bernhardt, MD, Principal Investigator
North Shore Hematology/Oncology, East Setauket, New York, 11733, United States; Recruiting
S Goldberg 631-751-3000
Edward Samuel, MD, Principal Investigator
Edward Samuel, MD, Principal Investigator
North Carolina
Piedmont Hematology Oncology Associates, Winston Salem, North Carolina, 27103, United States; Recruiting
A Gilbert 336-277-8887
Richard Brodkin, MD, Principal Investigator
Richard Brodkin, MD, Principal Investigator
North Dakota
St. Alexius Medical Center, Bismarck, North Dakota, 58501, United States; Recruiting
S Schock 701-530-6970
Bipinkumar Amin, MD, Principal Investigator
Bipinkumar Amin, MD, Principal Investigator
Pennsylvania
Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States; Recruiting
A Muskett 215-955-0024
Edith Mitchell, MD, Principal Investigator
Edith Mitchell, MD, Principal Investigator
South Carolina
Charleston Cancer Center, Charleston, South Carolina, 29406, United States; Recruiting
M Martin 843-576-1006
Charles D Graham, MD, Principal Investigator
Charles D Graham, MD, Principal Investigator
Tennessee
The Sarah Canon Cancer Center, Nashville, Tennessee, 37203, United States; Recruiting
D Carpenter 615-986-4300
Howard A Burris, III, MD, Principal Investigator
Howard A Burris, III, MD, Principal Investigator
East Tenn Oncology/Hematology, Knoxville, Tennessee, 37920, United States; Recruiting
S Owenby 865-549-4107
Tracy Dobbs, MD, Principal Investigator
Tracy Dobbs, MD, Principal Investigator
Utah
Northern Utah Associates, Ogden, Utah, 84403, United States; Recruiting
M Hansen 801-387-7166
Vincent Hansen, MD, Principal Investigator
Vincent Hansen, MD, Principal Investigator
Virginia
Virginia Cancer Institute, Richmond, Virginia, 23230, United States; Recruiting
A Meleason 804-282-3314
Christopher Desch, MD, Principal Investigator
Christopher Desch, MD, Principal Investigator
More Information
Study ID Numbers: CA225014
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: June 4, 2003
ClinicalTrials.gov Identifier: NCT00061815
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: June 4, 2003
ClinicalTrials.gov Identifier: NCT00061815
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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