Colorectal CancerPhase 2NCT01418222
FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing 5-FU, FOLFOX regimen and bevacizumab [Avastin] in people with Colorectal Cancer, run by Genentech, Inc. at 23 sites in United States.
Trial summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with 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?
- 5-FU, FOLFOX regimen and bevacizumab [Avastin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 23 sitesUnited States
- Study dates
- 14 Sep 2011to 18 Mar 2013
- Phase
- Phase 2
- 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 or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease by RECIST criteria
- Adequate organ system function, as defined by protocol
Who cannot join
- Prior systemic or radiation therapy for metastatic colorectal cancer
- Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
- Previously untreated brain metastases
- History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- History of hematemesis or hemoptysis </= 1 months prior to study enrollment
Show all 10Show fewer
- Significant cardiovascular disease or disorder
- History of abdominal fistula or gastrointestinal perforation </= 6 months prior to Day 1
- Positive for hepatitis B, hepatitis C or HIV infection
- Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Georgia Cancer Specialists - Northside
Atlanta, Georgia, 30341
Center For Cancer and Blood Disorders
Bethesda, Maryland, 20817
Saint Louis Cancer Care, LLP
Bridgeton, Missouri, 63044
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
University of Chicago; Hematology/Oncology
Chicago, Illinois, 60637
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, 29210
Rocky Mountain Cancer Centers; Bone and Marrow Trans
Denver, Colorado, 80218
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33901
Ctr for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Ingalls Cancer Research Center
Harvey, Illinois, 60426
Ingalls Memorial Hospital; Cancer Research Center
Harvey, Illinois, 60426
Research Medical Center - Antibiotic Research Associates, Inc.
Kansas City, Missouri, 64132
Baptist Hospital East
Louisville, Kentucky, 40207
Hem-Onc Assoc of Northern NJ
Morristown, New Jersey, 07960
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, 37203
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City, Oklahoma, 73104
Florida Hospital Cancer Inst
Orlando, Florida, 32804
Virginia Cancer Institute
Richmond, Virginia, 23226
South Texas Oncology & Hematology, P.A.
San Antonio, Texas, 78229
Almac Clinical Technologies
San Francisco, California, 94105
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Toledo Comm. Onc. Program
Toledo, Ohio, 43623
About this study
Official title: Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- 5-FU, FOLFOX regimen, Placebo, bevacizumab [Avastin], leucovorin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FUDrug
Intravenous repeating dose
FOLFOX regimenDrug
Intravenous repeating dose
PlaceboDrug
Intravenous repeating dose
bevacizumab [Avastin]Drug
Intravenous repeating dose
leucovorinDrug
Intravenous repeating dose
onartuzumab [MetMAb]Drug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: 5-FU; Drug: FOLFOX regimen; Drug: bevacizumab [Avastin]; Drug: leucovorin; Drug: onartuzumab [MetMAb] |
| B | Active comparator | Not described Receives: Drug: 5-FU; Drug: FOLFOX regimen; Drug: Placebo; Drug: bevacizumab [Avastin]; Drug: leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
Measured: up to 4 years
Secondary outcomes (4)
Response rate (complete response + partial response)
Measured: up to 4 years
Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death
Measured: up to 4 years
Overall survival
Measured: up to 4 years
Safety: Incidence of adverse events
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 posted17 Aug 2011 (estimated)
- Study start14 Sep 2011
- Primary completion18 Mar 2013
- Study completion18 Mar 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.
- More trials run by Genentech, Inc.The 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418222
- Sponsor's protocol ID
- GO27827
- Status last verified
- May 2017
- First submitted
- 15 Aug 2011
- Last updated
- 30 May 2017
- Results posted
- No
Publications
Bendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16.
PubMed 28209746
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01418222
- Acronym / sponsor ID
- GO27827
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- 14 Sep 2011 (actual)
- Primary completion
- 18 Mar 2013 (actual)
- Study completion
- 18 Mar 2013 (actual)
- First posted
- 17 Aug 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, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 5-FU, Drug: FOLFOX regimen, Drug: bevacizumab [Avastin], Drug: leucovorin, Drug: onartuzumab [MetMAb] |
| B | Active comparator | Drug: 5-FU, Drug: FOLFOX regimen, Drug: Placebo, Drug: bevacizumab [Avastin], Drug: leucovorin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease by RECIST criteria
- Adequate organ system function, as defined by protocol
Key exclusion criteria (10 listed)
- Prior systemic or radiation therapy for metastatic colorectal cancer
- Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
- Previously untreated brain metastases
- History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
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 |
|---|---|---|
| 5-FUIntravenous repeating dose | Drug | A, B |
| FOLFOX regimenIntravenous repeating dose | Drug | A, B |
| PlaceboIntravenous repeating dose | Drug | B |
| bevacizumab [Avastin]Intravenous repeating dose | Drug | A, B |
| leucovorinIntravenous repeating dose | Drug | A, B |
| onartuzumab [MetMAb]Intravenous repeating dose | Drug | A |
Primary outcome
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria
Time frame: up to 4 years
4 secondary outcomes
Response rate (complete response + partial response)
Time frame: up to 4 years
Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death
Time frame: up to 4 years
Overall survival
Time frame: up to 4 years
Safety: Incidence of adverse events
Time frame: up to 4 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 30 May 2017.
- Derived from this study: PubMed 28209746Bendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16.
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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
Genentech, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-FU, FOLFOX regimen and bevacizumab [Avastin] in people with Colorectal Cancer, run by Genentech, Inc. at 23 sites in United States.
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 5 inclusion and 10 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Progression-free survival: time from randomization to tumor progression or death, tumor 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?
On the ClinicalTrials.gov record for NCT01418222, 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 30 May 2017.