Colorectal CancerPhase 3ACT2NCT01229813
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.
A Phase 3 study testing bevacizumab, erlotinib, bevacizumab and low dose capecitabine in people with Colorectal Cancer, run by Lund University Hospital at 12 sites in 2 countries.
Trial summary
Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. 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, erlotinib, bevacizumab and low dose capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2010to Dec 2013
- 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
- Untreated metastatic colorectal carcinoma
- Age 18 yrs or over
- Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
- ECOG performance status 0 or 1
- Life expectancy more than 3 months
- Adequate haematological, renal and liver function
- Tumor tissue available for determination of KRAS mutational status
- Blood sample and paraffin embedded tumor tissue for translational research
Who cannot join
- Adjuvant therapy within 6 months
- CNS metastases
- Clinically significant atherosclerotic vascular disease
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Sweden11 sites
County Hospital Ryhov
Jönköping
County Hospital
Kalmar
Central Hospital
Karlstad
University Hospital
Linköping
Skåne University Hospital-Lund
Lund, 221 85
Karolinska University Hospital
Stockholm
Sundsvall Hospital
Sundsvall
Norrland University Hospital
Umeå
Akademiska Hospital
Uppsala
Central Hospital
Västerås
Central Hospital
Vaxjo
About this study
Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.
- Conditions
- Colorectal Cancer
- Being tested
- bevacizumab, erlotinib, bevacizumab, low dose capecitabine
- Keywords
- Untreated, First line, Chemotherapy, Maintenance treatment, KRAS wt, KRAS mutated, Anti-angiogenetic treatment, Metronomic capecitabine, bevacizumab, erlotinib, Translational research
- 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, erlotinibDrug
Also called Avastin, Tarceva
bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
bevacizumabDrug
Also called Tarceva
bevacizumab 7.5 mg/kg body weight every third week
bevacizumabDrug
Also called Avastin
bevacizumab 7.5 mg/kg body weight every third week.
low dose capecitabineDrug
Also called Xeloda
capecitabine 500 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab and erlotinib (KRAS WT) | Active comparator | Not described Receives: Drug: bevacizumab, erlotinib |
| bevacizumab (KRAS WT) | Active comparator | Not described Receives: Drug: bevacizumab |
| bevacizumab (KRAS mutated) | Active comparator | Not described Receives: Drug: bevacizumab |
| low dose capecitabine (KRAS mutated) | Active comparator | Not described Receives: Drug: low dose capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab.
Measured: 3 years
Secondary outcomes (1)
To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229813
- Sponsor's protocol ID
- ML 25359
- Acronym
- ACT2
- Status last verified
- Nov 2013
- First submitted
- 27 Oct 2010
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hagman H, Frodin JE, Berglund A, Sundberg J, Vestermark LW, Albertsson M, Fernebro E, Johnsson A. A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer: the Nordic ACT2 trial. Ann Oncol. 2016 Jan;27(1):140-7. doi: 10.1093/annonc/mdv490. Epub 2015 Oct 19.
PubMed 26483047
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT01229813
- Acronym / sponsor ID
- ACT2 / ML 25359
- Conditions
- Colorectal Cancer
- Keywords
- Untreated, First line, Chemotherapy, Maintenance treatment, KRAS wt, KRAS mutated, Anti-angiogenetic treatment, Metronomic capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Oct 2010 (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.
Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bevacizumab and erlotinib (KRAS WT) | Active comparator | Drug: bevacizumab, erlotinib |
| bevacizumab (KRAS WT) | Active comparator | Drug: bevacizumab |
| bevacizumab (KRAS mutated) | Active comparator | Drug: bevacizumab |
| low dose capecitabine (KRAS mutated) | Active comparator | Drug: low dose capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Untreated metastatic colorectal carcinoma
- Age 18 yrs or over
- Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
- ECOG performance status 0 or 1
- Life expectancy more than 3 months
Key exclusion criteria (3 listed)
- Adjuvant therapy within 6 months
- CNS metastases
- Clinically significant atherosclerotic vascular disease
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, erlotinibAlso: Avastin, Tarcevabevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily | Drug | bevacizumab and erlotinib (KRAS WT) |
| bevacizumabAlso: Tarcevabevacizumab 7.5 mg/kg body weight every third week | Drug | bevacizumab (KRAS WT) |
| bevacizumabAlso: Avastinbevacizumab 7.5 mg/kg body weight every third week. | Drug | bevacizumab (KRAS mutated) |
| low dose capecitabineAlso: Xelodacapecitabine 500 mg twice daily | Drug | low dose capecitabine (KRAS mutated) |
Primary outcome
To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab.
Time frame: 3 years
1 secondary outcome
To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Derived from this study: PubMed 26483047Hagman H, Frodin JE, Berglund A, Sundberg J, Vestermark LW, Albertsson M, Fernebro E, Johnsson A. A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer: the Nordic ACT2 trial. Ann Oncol. 2016 Jan;27(1):140-7. doi: 10.1093/annonc/mdv490. Epub 2015 Oct 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab, erlotinib, bevacizumab and low dose capecitabine in people with Colorectal Cancer, run by Lund University Hospital at 12 sites in 2 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 8 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden, Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01229813, which also lists 1 linked publication.
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 13 Apr 2015.