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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab+FOLFOX4 | Experimental |
|
|
| FOLFOX4. | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Biological | 400 mg/m2 IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone. | Every six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the response rates between the two treatment arms. | Every six weeks | |
| Compare progression-free survival between the two treatment arms. | Every six weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E-mail: ClinicalTrials@ ImClone.com | Eli Lilly and Company | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| ImClone Investigational Site |
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| oxaliplatin | Drug | 85 mg/m2 IV |
|
|
| leucovorin | Drug | 200 mg/m2 IV |
|
|
| 5-fluorouracil | Drug | 400 mg/m2 IV |
|
|
| 5-fluorouracil | Drug | 600 mg/m2 IV |
|
|
| cetuximab | Biological | 250 mg/m2 IV |
|
|
| Duration of response within each treatment arm. |
| Every six weeks |
| Time to response within each treatment arm. | Every six weeks |
| Compare the safety profiles between the two treatment arms. | Every six weeks |
| Compare the quality of life (QOL)between the two treatment arms. | Every six weeks |
| Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms. | Every six weeks |
| Springdale |
| Arkansas |
| 72764 |
| United States |
| ImClone Investigational Site | Fountain Valley | California | 92708 | United States |
| ImClone Investigational Site | Gilroy | California | 95020 | United States |
| ImClone Investigational Site | Greenbrae | California | 94904 | United States |
| ImClone Investigational Site | Orange | California | 92868 | United States |
| ImClone Investigational Site | Pomona | California | 91767 | United States |
| ImClone Investigational Site | San Diego | California | 92120 | United States |
| ImClone Investigational Site | Vista | California | 92083 | United States |
| ImClone Investigational Site | Hartford | Connecticut | 06105 | United States |
| ImClone Investigational Site | Norwalk | Connecticut | 06856 | United States |
| ImClone Investigational Site | Stamford | Connecticut | 06902 | United States |
| ImClone Investigational Site | Waterbury | Connecticut | 06708 | United States |
| ImClone Investigational Site | Boynton Beach | Florida | 33435 | United States |
| ImClone Investigational Site | Jacksonville | Florida | 32207 | United States |
| ImClone Investigational Site | Leesburg | Florida | 34748 | United States |
| ImClone Investigational Site | Orlando | Florida | 32804 | United States |
| ImClone Investigational Site | Tampa | Florida | 33613 | United States |
| ImClone Investigational Site | Atlanta | Georgia | 30309 | United States |
| ImClone Investigational Site | Macon | Georgia | 31201 | United States |
| ImClone Investigational Site | Louisville | Kentucky | 40202 | United States |
| ImClone Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| ImClone Investigational Site | Baltimore | Maryland | 21225 | United States |
| ImClone Investigational Site | Clinton | Maryland | 20735 | United States |
| ImClone Investigational Site | Saint Joseph | Michigan | 49085 | United States |
| ImClone Investigational Site | Kansas City | Missouri | 64131 | United States |
| ImClone Investigational Site | Rolla | Missouri | 65401 | United States |
| ImClone Investigational Site | Hackensack | New Jersey | 07601 | United States |
| ImClone Investigational Site | Armonk | New York | 10504 | United States |
| ImClone Investigational Site | Brooklyn | New York | 11235 | United States |
| ImClone Investigational Site | East Setauket | New York | 11733 | United States |
| ImClone Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| ImClone Investigational Site | Bismarck | North Dakota | 58501 | United States |
| ImClone Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| ImClone Investigational Site | Charleston | South Carolina | 29406 | United States |
| ImClone Investigational Site | Knoxville | Tennessee | 37920 | United States |
| ImClone Investigational Site | Nashville | Tennessee | 37203 | United States |
| ImClone Investigational Site | Ogden | Utah | 84403 | United States |
| ImClone Investigational Site | Richmond | Virginia | 23230 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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