Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00061815 | Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer | PHASE3 | COMPLETED | 102 | — | — | Mar 1, 2003 | Nov 1, 2005 | Apr 12, 2010 | 39 | United States |
| Arm | Type | Description |
|---|---|---|
| Cetuximab+FOLFOX4 | EXPERIMENTAL | * Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion * Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion * Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes |
| FOLFOX4. | ACTIVE_COMPARATOR | * Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion. * Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion. |
| Name | Type | Description |
|---|---|---|
| cetuximab | BIOLOGICAL | 400 mg/m2 IV |
| oxaliplatin | DRUG | 85 mg/m2 IV |
| leucovorin | DRUG | 200 mg/m2 IV |
| 5-fluorouracil | DRUG | 400 mg/m2 IV |
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 im...