Colorectal CancerPhase 3NCT01338558
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
A Phase 3 study testing bevacizumab [Avastin], cetuximab and mFOLFOX6 in people with Colorectal Cancer, run by Hoffmann-La Roche.
Trial summary
This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. 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], cetuximab and mFOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Histologically confirmed adenocarcinoma of the colon or rectum
- Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
- Tumour tissue sample available for assessment of K-RAS and BRAF genes
- Prior radiotherapy must have been completed 4 weeks before randomization
- Adequate bone marrow, kidney and liver function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Who cannot join
- Previous chemotherapy for metastatic disease
- Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
- Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
- Clinical or radiographic evidence of brain metastases
- Clinically significant cardiovascular disease or disorder
- History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
- HIV, hepatitis B or C infection
About this study
This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
- Conditions
- Colorectal Cancer
- Being tested
- bevacizumab [Avastin], cetuximab, mFOLFOX6
- 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
5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent
cetuximabDrug
400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent
mFOLFOX6Drug
Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
| Study group | Role | What they receive |
|---|---|---|
| K-RAS mutated | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: mFOLFOX6 |
| K-RAS native A | Experimental | Not described Receives: Drug: bevacizumab [Avastin]; Drug: mFOLFOX6 |
| K-RAS native B | Active comparator | Not described Receives: Drug: cetuximab; Drug: mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
Measured: up to 4 years
Secondary outcomes (5)
Overall survival
Measured: up to 4 years
Objective response rate
Measured: 4 years
Safety: Incidence of adverse events
Measured: 4 years
Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)
Measured: up to 4 years
Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT01338558
- Sponsor's protocol ID
- ML25686
- Status last verified
- Nov 2016
- First submitted
- 18 Apr 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
- ClinicalTrials.gov ID
- NCT01338558
- Acronym / sponsor ID
- ML25686
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| K-RAS mutated | Experimental | Drug: bevacizumab [Avastin], Drug: mFOLFOX6 |
| K-RAS native A | Experimental | Drug: bevacizumab [Avastin], Drug: mFOLFOX6 |
| K-RAS native B | Active comparator | Drug: cetuximab, Drug: mFOLFOX6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients >/= 18 years of age
- Histologically confirmed adenocarcinoma of the colon or rectum
- Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
- Tumour tissue sample available for assessment of K-RAS and BRAF genes
- Prior radiotherapy must have been completed 4 weeks before randomization
Key exclusion criteria (7 listed)
- Previous chemotherapy for metastatic disease
- Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
- Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
- Clinical or radiographic evidence of brain metastases
- Clinically significant cardiovascular disease or disorder
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]5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent | Drug | K-RAS mutated, K-RAS native A |
| cetuximab400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent | Drug | K-RAS native B |
| mFOLFOX6Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent | Drug | K-RAS mutated, K-RAS native A, K-RAS native B |
Primary outcome
Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
Time frame: up to 4 years
5 secondary outcomes
Overall survival
Time frame: up to 4 years
Objective response rate
Time frame: 4 years
Safety: Incidence of adverse events
Time frame: 4 years
Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)
Time frame: up to 4 years
Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms
Time frame: up to 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab [Avastin], cetuximab and mFOLFOX6 in people with Colorectal Cancer, run by Hoffmann-La Roche.
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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria (time frame: up to 4 years). 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 2 Nov 2016.