Trial Information

Summary: A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.

Status: No longer recruiting

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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Pharmacokinetics

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2006

Trial Registration Date: 07/06/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:32:15 PM