A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bevacizumab [Avastin]
XELOX
bevacizumab [Avastin]
FOLFOX-4
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Weekly Steady-state Exposure of Bevacizumab
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.
Secondary Outcome Measures
Time Zero to Last Measurable Plasma Concentration of Bevacizumab
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
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
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
Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.
Serum Clearance of Bevacizumab
Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.
Time of Maximum Serum Concentration of Bevacizumab
Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.
Volume of Distribution of Bevacizumab at Steady State
Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.
Terminal Half-life of Bevacizumab
Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349336
Brief Title
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
7.5mg/kg iv on day 1 of each 3 week cycle
Intervention Type
Drug
Intervention Name(s)
XELOX
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
5mg/kg iv on day 1 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
FOLFOX-4
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Weekly Steady-state Exposure of Bevacizumab
Description
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.
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Time Zero to Last Measurable Plasma Concentration of Bevacizumab
Description
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.
Time Frame
Up to 48 weeks
Title
Steady-state Exposure of Bevacizumab From Time Zero to Tau
Description
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.
Time Frame
Up to 48 weeks
Title
Maximum Serum Concentration of Bevacizumab at Steady State
Description
Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.
Time Frame
Up to 48 weeks
Title
Minimum Serum Concentration of Bevacizumab at Steady State
Description
Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.
Time Frame
Up to 48 weeks
Title
Serum Clearance of Bevacizumab
Description
Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.
Time Frame
Up to 48 weeks
Title
Time of Maximum Serum Concentration of Bevacizumab
Description
Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.
Time Frame
Up to 48 weeks
Title
Volume of Distribution of Bevacizumab at Steady State
Description
Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.
Time Frame
Up to 48 weeks
Title
Terminal Half-life of Bevacizumab
Description
Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.
Time Frame
Up to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
City
Sydney
ZIP/Postal Code
2031
Country
Australia
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Christchurch
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
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