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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00349336




Registration number
NCT00349336
Ethics application status
Date submitted
6/07/2006
Date registered
7/07/2006
Date last updated
18/09/2012

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
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
Secondary ID [1] 0 0
NO20254
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - XELOX
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - FOLFOX-4

Experimental: 1 -

Experimental: 2 -


Treatment: Drugs: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle

Treatment: Drugs: XELOX
As prescribed

Treatment: Drugs: bevacizumab [Avastin]
5mg/kg iv on day 1 of each 2 week cycle

Treatment: Drugs: FOLFOX-4
As prescribed

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to 48 weeks
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to 48 weeks
Secondary outcome [5] 0 0
Serum Clearance of Bevacizumab - Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.
Timepoint [5] 0 0
Up to 48 weeks
Secondary outcome [6] 0 0
Time of Maximum Serum Concentration of Bevacizumab - Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.
Timepoint [6] 0 0
Up to 48 weeks
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Up to 48 weeks
Secondary outcome [8] 0 0
Terminal Half-life of Bevacizumab - Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.
Timepoint [8] 0 0
Up to 48 weeks

Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;

- adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;

- >=1 target lesion.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Box Hill
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
2031 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00349336
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications