Colorectal CancerPhase 2NCT00743678
Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
A Phase 2 study testing FOLFOX6/cetuximab in people with Colorectal Cancer and Unresectable Liver Metastasis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Unresectable Liver Metastasis
- What is being tested?
- FOLFOX6/cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to 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 proven colorectal cancer with metastatic lesion(s) in the liver that is (are) unresectable
- Age ≥ 18
- ECOG performance 0 - 1
- Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin < 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet > 100,000/ul, absolute neutrophil count ≥ 1,500/ul)
- At least one measurable lesion by RECIST criteria
- Written informed consent
Who cannot join
- Resectable liver metastasis
- Extrahepatic metastases, regardless of their resectability
- Chronic active hepatitis or cirrhosis
- Prior therapy for metastatic disease
- Pregnant or lactating women
- Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months
Show all 15Show fewer
- Previous adjuvant FOLFOX chemotherapy
- Prior adjuvant chemotherapy, if administered within 6 months before study entry
- Known hypersensitivity reaction to any of the components of study treatment
- Prior agents directed against EGFR
- Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy
- Known alcohol or drug abuse
- Participation in another clinical study within the 30 days before registration
- Peripheral neuropathy > grade 1
- Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin of pre-invasive carcinoma of the cervix.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Therefore, the investigators propose a prospective study of neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver metastasis to potentially resectable disease.
Read the detailed description
We will include the patients with unresectable liver-only metastatic disease independent of EGFR status. The results of this study will show the resection rate with neoadjuvant treatment in patients with colorectal cancer with liver-only metastasis.
Restaging including CT after #3, #6, #9, and #12 cycles of FOLFOX + Cetuximab
If any time, patients have PD, Off-study SD, Continue study treatment until resectable, up to #12 cycles, PD, or toxicities PR or more, If resectable, go to surgery : resection of liver metastasis and primary tumor, if present If unresectable, continue until resectable, up to #12 cycles, PD, or toxicities
Overall, a total of 12 cycles of treatment including neoadjuvant therapy will be given either before, after or without surgery.
CT scans will be performed every 3 cycles during the first 12 cycles (6 months). After that, CT scans will be performed every 2 months for another 6 months, then every 3 months for 6 months, then once a year or earlier if a PD is probable.
AEs will be evaluated once every cycle and during the CT evaluation visit.. Patients that can only undergo R1 resection or are unable to get surgery at all, will be evaluated regularly until PD.
Radiofrequency ablation (RFA) may be allowed as a palliative local therapy in patients that are suitable for it. RFA is not considered equal to a resection.
- Conditions
- Colorectal Cancer, Unresectable Liver Metastasis
- Being tested
- FOLFOX6/cetuximab
- Keywords
- Colorectal Cancer, Unresectable liver metastasis, FOLFOX6, Cetuximab, Neoadjuvant therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX6/cetuximabDrug
Neoadjuvant FOLFOX6/cetuximab
| Study group | Role | What they receive |
|---|---|---|
| NEO | Experimental | NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab Receives: Drug: FOLFOX6/cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis
Measured: 18 months
Secondary outcomes (4)
Response rate (according to RECIST)
Measured: 24 months
Progression-free survival time
Measured: 24 months
Overall survival timeToxicity profile (according to NCI CTCAE v3)
Measured: 24 months
Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2012
- Study completionJun 2012
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 Samsung 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Suk Park, Samsung Medical Center
- Investigators
- Young Suk Park, M.D.,Ph.D., Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743678
- Sponsor's protocol ID
- 2008-04-018
- Status last verified
- Jun 2013
- First submitted
- 27 Aug 2008
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
- ClinicalTrials.gov ID
- NCT00743678
- Acronym / sponsor ID
- 2008-04-018
- Conditions
- Colorectal Cancer, Unresectable Liver Metastasis
- Keywords
- Colorectal Cancer, Unresectable liver metastasis, FOLFOX6, Cetuximab, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Aug 2008 (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.
An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Therefore, the investigators propose a prospective study of neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver metastasis to potentially resectable disease.
Detailed description
We will include the patients with unresectable liver-only metastatic disease independent of EGFR status. The results of this study will show the resection rate with neoadjuvant treatment in patients with colorectal cancer with liver-only metastasis.
Restaging including CT after #3, #6, #9, and #12 cycles of FOLFOX + Cetuximab
If any time, patients have PD, Off-study SD, Continue study treatment until resectable, up to #12 cycles, PD, or toxicities PR or more, If resectable, go to surgery : resection of liver metastasis and primary tumor, if present If unresectable, continue until resectable, up to #12 cycles, PD, or toxicities
Overall, a total of 12 cycles of treatment including neoadjuvant therapy will be given either before, after or without surgery.
CT scans will be performed every 3 cycles during the first 12 cycles (6 months). After that, CT scans will be performed every 2 months for another 6 months, then every 3 months for 6 months, then once a year or earlier if a PD is probable.
AEs will be evaluated once every cycle and during the CT evaluation visit.. Patients that can only undergo R1 resection or are unable to get surgery at all, will be evaluated regularly until PD.
Radiofrequency ablation (RFA) may be allowed as a palliative local therapy in patients that are suitable for it. RFA is not considered equal to a resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEO | Experimental | Drug: FOLFOX6/cetuximabNEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven colorectal cancer with metastatic lesion(s) in the liver that is (are) unresectable
- Age ≥ 18
- ECOG performance 0 - 1
- Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin < 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet > 100,000/ul, absolute neutrophil count ≥ 1,500/ul)
- At least one measurable lesion by RECIST criteria
Key exclusion criteria (15 listed)
- Resectable liver metastasis
- Extrahepatic metastases, regardless of their resectability
- Chronic active hepatitis or cirrhosis
- Prior therapy for metastatic disease
- Pregnant or lactating women
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 |
|---|---|---|
| FOLFOX6/cetuximabNeoadjuvant FOLFOX6/cetuximab | Drug | NEO |
Primary outcome
To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis
Time frame: 18 months
4 secondary outcomes
Response rate (according to RECIST)
Time frame: 24 months
Progression-free survival time
Time frame: 24 months
Overall survival timeToxicity profile (according to NCI CTCAE v3)
Time frame: 24 months
Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival
Time frame: 24 months
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 14 Jun 2013.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Young Suk Park, M.D.,Ph.D. principal investigator
Samsung Medical Center, Seoul, Korea
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 FOLFOX6/cetuximab in people with Colorectal Cancer and Unresectable Liver Metastasis, run by Samsung 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 6 inclusion and 15 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 14 Jun 2013. 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?
To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis (time frame: 18 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 14 Jun 2013.