Phase 3
Completed N=64
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
Source: ClinicalTrials.gov NCT00349336 ↗Enrolled (actual)
64
Serious AEs
37.5%
Results posted
Feb 2010
Primary outcomePrimary: Weekly Steady-state Exposure of Bevacizumab — 4090.3; 4022.4 day*ug/mL
Summary
This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weekly Steady-state Exposure of Bevacizumab |
4090.3; 4022.4 | — |
| SECONDARY Time Zero to Last Measurable Plasma Concentration of Bevacizumab |
2457.19; 1709.8 | — |
| SECONDARY Steady-state Exposure of Bevacizumab From Time Zero to Tau |
2457.0; 1758.4 | — |
| SECONDARY Maximum Serum Concentration of Bevacizumab at Steady State |
242; 215.6 | — |
| SECONDARY Minimum Serum Concentration of Bevacizumab at Steady State |
59.6; 80.0 | — |
| SECONDARY Serum Clearance of Bevacizumab |
0.236; 0.226 | — |
| SECONDARY Time of Maximum Serum Concentration of Bevacizumab |
6.442; 4.958 | — |
| SECONDARY Volume of Distribution of Bevacizumab at Steady State |
4.932; 4.908 | — |
| SECONDARY Terminal Half-life of Bevacizumab |
381.2; 394.1 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
- >=1 target lesion.
Exclusion Criteria
- patients who have previously received systemic treatment for advanced or metastatic disease;
- patients who have received adjuvant treatment for non-metastatic disease in past 3 months;
- previous therapy with oxaliplatin or Avastin.
Data sourced from ClinicalTrials.gov (NCT00349336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.