Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00349336
First received: July 6, 2006
Last updated: September 12, 2012
Last verified: September 2012

July 6, 2006
September 12, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   New Zealand
 
NCT00349336
NO20254
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