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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Time Zero to Last Measurable Plasma Concentration of Bevacizumab
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [2] 0 0
Steady-state Exposure of Bevacizumab From Time Zero to Tau
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [3] 0 0
Maximum Serum Concentration of Bevacizumab at Steady State
Timepoint [3] 0 0
Up to 48 weeks
Secondary outcome [4] 0 0
Minimum Serum Concentration of Bevacizumab at Steady State
Timepoint [4] 0 0
Up to 48 weeks
Secondary outcome [5] 0 0
Serum Clearance of Bevacizumab
Timepoint [5] 0 0
Up to 48 weeks
Secondary outcome [6] 0 0
Time of Maximum Serum Concentration of Bevacizumab
Timepoint [6] 0 0
Up to 48 weeks
Secondary outcome [7] 0 0
Volume of Distribution of Bevacizumab at Steady State
Timepoint [7] 0 0
Up to 48 weeks
Secondary outcome [8] 0 0
Terminal Half-life of Bevacizumab
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
Sex
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
64
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00349336