Colorectal CancerPhase 3NCT00349336
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
A Phase 3 study testing bevacizumab [Avastin], XELOX and FOLFOX-4 in people with Colorectal Cancer, run by Hoffmann-La Roche at 7 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- bevacizumab [Avastin], XELOX and FOLFOX-4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2006to Nov 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, >=18 years of age;
- adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
- >=1 target lesion.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Australia3 sites
Study site
Box Hill, 3128
Study site
Fitzroy, 3065
Study site
Sydney, 2031
Canada3 sites
Study site
Brampton, Ontario, L6R 3J7
Study site
Hamilton, Ontario, L8V 5C2
Study site
Toronto, Ontario, M5G 2M9
About this study
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
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.
- Conditions
- Colorectal Cancer
- Being tested
- bevacizumab [Avastin], XELOX, FOLFOX-4
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab [Avastin]Drug
7.5mg/kg iv on day 1 of each 3 week cycle
XELOXDrug
As prescribed
bevacizumab [Avastin]Drug
5mg/kg iv on day 1 of each 2 week cycle
FOLFOX-4Drug
As prescribed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: XELOX |
| 2 | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: FOLFOX-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 weeks
Secondary outcomes (8)
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.
Measured: Up to 48 weeks
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.
Measured: Up to 48 weeks
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.
Measured: Up to 48 weeks
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.
Measured: Up to 48 weeks
Serum Clearance of Bevacizumab
Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.
Measured: Up to 48 weeks
Time of Maximum Serum Concentration of Bevacizumab
Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.
Measured: Up to 48 weeks
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.
Measured: Up to 48 weeks
Terminal Half-life of Bevacizumab
Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349336
- Sponsor's protocol ID
- NO20254
- Status last verified
- Sep 2012
- First submitted
- 6 Jul 2006
- Last updated
- 18 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00349336
- Acronym / sponsor ID
- NO20254
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Jul 2006 (estimated)
- Results
- Posted 26 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab [Avastin], Drug: XELOX |
| 2 | Experimental | Drug: bevacizumab [Avastin], Drug: FOLFOX-4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, >=18 years of age;
- adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
- >=1 target lesion.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab [Avastin]7.5mg/kg iv on day 1 of each 3 week cycle | Drug | 1 |
| XELOXAs prescribed | Drug | 1 |
| bevacizumab [Avastin]5mg/kg iv on day 1 of each 2 week cycle | Drug | 2 |
| FOLFOX-4As prescribed | Drug | 2 |
Primary outcome
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.
8 secondary outcomes
Time Zero to Last Measurable Plasma Concentration of Bevacizumab
Time frame: Up to 48 weeks
Steady-state Exposure of Bevacizumab From Time Zero to Tau
Time frame: Up to 48 weeks
Maximum Serum Concentration of Bevacizumab at Steady State
Time frame: Up to 48 weeks
Minimum Serum Concentration of Bevacizumab at Steady State
Time frame: Up to 48 weeks
Serum Clearance of Bevacizumab
Time frame: Up to 48 weeks
Time of Maximum Serum Concentration of Bevacizumab
Time frame: Up to 48 weeks
Volume of Distribution of Bevacizumab at Steady State
Time frame: Up to 48 weeks
Terminal Half-life of Bevacizumab
Time frame: Up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab [Avastin], XELOX and FOLFOX-4 in people with Colorectal Cancer, run by Hoffmann-La Roche at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Steady-state Exposure of Bevacizumab (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.