Metastatic Colorectal CancerPhase 2NCT00378066
Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer
A Phase 2 study testing Bevacizumab in people with Metastatic Colorectal Cancer, run by Asan Medical Center at 6 sites in South Korea.
Trial summary
The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Aug 2006to Oct 2008
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented colorectal adenocarcinoma
- ECOG performance status of 2 or lower
- Adequate bone marrow function
- Adequate kidney function
- Adequate liver function
- Informed consent
Who cannot join
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
- Known allergy to study drugs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
National Cancer Center
Goyang
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Yonsei University Hospital
Seoul
Bundang Seoul National University Hospital
Sungnam
About this study
Official title: A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer
The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- 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.
BevacizumabDrug
Also called Capecitabine, Oxaliplatin
Bevacizumab, Capecitabine, Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Active comparator | Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression
Measured: 6 months
Secondary outcomes (1)
overall survival, safety, response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2006
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 49 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., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378066
- Sponsor's protocol ID
- AMC-ONCGI-0277
- Status last verified
- Jan 2013
- First submitted
- 18 Sep 2006
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00378066
- Acronym / sponsor ID
- AMC-ONCGI-0277
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Sep 2006 (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.
The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Active comparator | Drug: BevacizumabBevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically documented colorectal adenocarcinoma
- ECOG performance status of 2 or lower
- Adequate bone marrow function
- Adequate kidney function
- Adequate liver function
Key exclusion criteria (2 listed)
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
- Known allergy to study drugs
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 |
|---|---|---|
| BevacizumabAlso: Capecitabine, OxaliplatinBevacizumab, Capecitabine, Oxaliplatin | Drug | Bevacizumab |
Primary outcome
time to progression
Time frame: 6 months
1 secondary outcome
overall survival, safety, response
Time frame: 1 year
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 23 Jan 2013.
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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.
Tae Won Kim, M.D. principal investigator
Asan Medical Center
6 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 Bevacizumab in people with Metastatic Colorectal Cancer, run by Asan Medical Center at 6 sites 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 6 inclusion and 2 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
time to progression (time frame: 6 months). 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 23 Jan 2013.