Trial information
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
Status: Completed
Protocol number: NO20254
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: A Randomized, Open Label Trial to assess the Steady State Pharmacokinetics of Avastin given with either XELOX or FOLFOX-4 in Patients with Metastatic Colorectal Cancer
Brief 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. Target sample size is
60.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Pharmacokinetics study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Steady state AUC, Cmax, Cmin, Tmax, CL, V and t1/2 of bevacizumab. Time frame: Cycle 5 for XELOX arm, cycle 7 for FOLFOX arm.
Key secondary outcomes: 1. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 07/06/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Canada
- Brampton, ON
- Hamilton, ON
- Toronto, ON
New Zealand
