Metastatic Colorectal CancerPhase 2SAFENCT00862342
Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC)
A Phase 2 study testing Bevacizumab (Avastin) in people with Metastatic Colorectal Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Bevacizumab (Avastin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jun 2012
- 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
- Histologically documented colorectal adenocarcinoma
- Progression during first-line bevacizumab containing chemotherapy within 3 months
- No serious toxicity to bevacizumab of 1st line treatment
- Unresectable metastases
- Uni-dimensional measurable lesion(s) by RECIST
- Age over 18 years old
- ECOG 0-2
- Adequate organ functions by clinical laboratory exams
Who cannot join
- Other tumor type than adenocarcinoma
- CNS metastases
- GI bleeding
- Hypersensitivity to any of chemotherapeutic agents
- Prior use of cetuximab or other targeted agents other than bevacizumab
- Major surgery within 6 weeks
- Other serious illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin
Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p < 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE.
The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.
Read the detailed description
Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Bevacizumab (Avastin)
- Keywords
- colorectal cancer, Bevacizumab
- 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
Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy Receives: Drug: Bevacizumab (Avastin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 6 weeks
Secondary outcomes (2)
Overall survival
Measured: 6 weeks
Toxicity profiles
Measured: 2 or 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionJun 2012
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Won Kim, Asan Medical Center
- Investigators
- Tae Won Kim, M.D., Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862342
- Sponsor's protocol ID
- AMC-2008-0487
- Acronym
- SAFE
- Status last verified
- Jul 2012
- First submitted
- 13 Mar 2009
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong YS, Lee J, Kim KP, Lee JL, Park YS, Park JO, Park SH, Kim SY, Baek JY, Kim JH, Lee KW, Kim TY, Kim TW. Multicenter phase II study of second-line bevacizumab plus doublet combination chemotherapy in patients with metastatic colorectal cancer progressed after upfront bevacizumab plus doublet combination chemotherapy. Invest New Drugs. 2013 Feb;31(1):183-91. doi: 10.1007/s10637-012-9853-3. Epub 2012 Jul 11.
PubMed 22782485
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin
- ClinicalTrials.gov ID
- NCT00862342
- Acronym / sponsor ID
- SAFE / AMC-2008-0487
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal cancer, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Mar 2009 (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.
Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p < 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE.
The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.
Detailed description
Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab (Avastin)Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically documented colorectal adenocarcinoma
- Progression during first-line bevacizumab containing chemotherapy within 3 months
- No serious toxicity to bevacizumab of 1st line treatment
- Unresectable metastases
- Uni-dimensional measurable lesion(s) by RECIST
Key exclusion criteria (7 listed)
- Other tumor type than adenocarcinoma
- CNS metastases
- GI bleeding
- Hypersensitivity to any of chemotherapeutic agents
- Prior use of cetuximab or other targeted agents other than bevacizumab
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)Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision) | Drug | Bevacizumab |
Primary outcome
Progression free survival
Time frame: 6 weeks
2 secondary outcomes
Overall survival
Time frame: 6 weeks
Toxicity profiles
Time frame: 2 or 3 weeks
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 17 Jul 2012.
- Results publication: PubMed 22782485Hong YS, Lee J, Kim KP, Lee JL, Park YS, Park JO, Park SH, Kim SY, Baek JY, Kim JH, Lee KW, Kim TY, Kim TW. Multicenter phase II study of second-line bevacizumab plus doublet combination chemotherapy in patients with metastatic colorectal cancer progressed after upfront bevacizumab plus doublet combination chemotherapy. Invest New Drugs. 2013 Feb;31(1):183-91. doi: 10.1007/s10637-012-9853-3. Epub 2012 Jul 11.
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CRC
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.
Tae Won Kim, M.D. study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab (Avastin) in people with Metastatic Colorectal Cancer, run by Asan Medical Center at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 frame: 6 weeks). 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 NCT00862342, 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 17 Jul 2012.