drugset / Trial / NCT00354978
Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Objectives: 1. To estimate progression-free survival (PFS) at 12 months in subjects with metastatic colorectal cancer who receive FOLFIRI \[folinic acid (leucovorin or LV), 5-Fluorouracil (5-FU), irinotecan) plus bevacizumab as first line treatment. 2. To determine the objective response rate and the duration of objective response in this population. 3. To assess overall survival (OS) in this population. 4. To measure the effect of treatment on intratumoral blood volume and microvascular permeability by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in consenting patients in whom it is technically feasible. 5. To correlate plasma proteomics with response. 6. To assess the safety of this regimen.
Timeline
- Start
- 2005-01
- Primary completion
- 2011-03
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2.4 g | Intravenous |