We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00349336
First Posted: July 7, 2006
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
July 6, 2006
July 7, 2006
June 2, 2009
February 26, 2010
September 18, 2012
August 2006
November 2008   (Final data collection date for primary outcome measure)
Weekly Steady-state Exposure of Bevacizumab [ Time Frame: Up to 48 weeks ]
Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.
Steady state AUC, Cmax, Cmin, tmax, CL, V and t1/2 of bevacizumab - cycle 5 for XELOX and cycle 7 for FOLFOX-4.
Complete list of historical versions of study NCT00349336 on ClinicalTrials.gov Archive Site
  • Time Zero to Last Measurable Plasma Concentration of Bevacizumab [ Time Frame: Up to 48 weeks ]
    Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.
  • Steady-state Exposure of Bevacizumab From Time Zero to Tau [ Time Frame: Up to 48 weeks ]
    Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.
  • Maximum Serum Concentration of Bevacizumab at Steady State [ Time Frame: Up to 48 weeks ]
    Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.
  • Minimum Serum Concentration of Bevacizumab at Steady State [ Time Frame: Up to 48 weeks ]
    Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.
  • Serum Clearance of Bevacizumab [ Time Frame: Up to 48 weeks ]
    Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.
  • Time of Maximum Serum Concentration of Bevacizumab [ Time Frame: Up to 48 weeks ]
    Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.
  • Volume of Distribution of Bevacizumab at Steady State [ Time Frame: Up to 48 weeks ]
    Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.
  • Terminal Half-life of Bevacizumab [ Time Frame: Up to 48 weeks ]
    Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.
AEs, laboratory tests.
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    7.5mg/kg iv on day 1 of each 3 week cycle
  • Drug: XELOX
    As prescribed
  • Drug: bevacizumab [Avastin]
    5mg/kg iv on day 1 of each 2 week cycle
  • Drug: FOLFOX-4
    As prescribed
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: XELOX
  • Experimental: 2
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: FOLFOX-4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
November 2008
November 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   New Zealand
 
 
NCT00349336
NO20254
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP