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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00354978 | Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients | PHASE2 | COMPLETED | 49 | — | — | Jan 1, 2005 | Mar 1, 2011 | Oct 21, 2011 | 2 | United States |
PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.
| Arm | Type | Description |
|---|---|---|
| FOLFIRI plus Bevacizumab | EXPERIMENTAL | FOLFIRI \[folinic acid (leucovorin) 400 mg/m\^2 by vein (IV) Day 1; 5-FU 400 mg/m\^2 IV injection Day 1 immediately followed by 2.4 g/m\^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m\^2 IV on Day 1\] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle. |
| Name | Type | Description |
|---|---|---|
| 5-Fluorouracil | DRUG | 400 mg/m\^2 injection by vein Day 1 of 14 day cycle immediately after completion of leucovorin infusion. 2.4 g/m\^2 by vein over 46 hours over Days 1-3 of 14 day cycle immediately after completion of 400 mg/m\^2 injection. |
| Bevacizumab | DRUG | 5 mg/kg over 90 minutes on Day 1 of first 14 day cycle as initial dose, administered alone without other drugs. 5 mg/kg by vein on Day 1 of 14 day cycle. |
| Leucovorin | DRUG | 400 mg/m\^2 over 2-4 minutes by vein on Day 1 of 14 day cycle. |
| Irinotecan | DRUG | 180 mg/m\^2 by vein over 90 minutes on Day 1 of 14 day cycle. |
Inclusion Criteria: 1. Patient must have histologically or cytologically confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies. 2. Patient must have measurable lesions as defined by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteri...