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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00192075 | A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer | PHASE2 | COMPLETED | 84 | — | — | Jun 1, 2003 | Nov 1, 2007 | Feb 7, 2011 | 15 | United States |
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
| Arm | Type | Description |
|---|---|---|
| A+FFG | EXPERIMENTAL | Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid |
| A+FOLFOX 4 | ACTIVE_COMPARATOR | Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | 900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression. |
| avastin | DRUG | 5 milligrams per kilogram (mg/kg) |
| 5FU/folinic acid | DRUG | Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG). Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). 5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). |
| oxaliplatin | DRUG | 85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle. |
Inclusion Criteria: * Patients must have a histological or cytological diagnosis of the colon or rectum with Stage III unresectable or Stage IV disease. * Urinalysis or Urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). If urine dipstick is greater than 1+, the 24 hour urine p...