Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NEO
NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab
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Neoadjuvant FOLFOX6/cetuximab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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18 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Response rate (according to RECIST)
Time Frame: 24 months
|
24 months
|
|
Progression-free survival time
Time Frame: 24 months
|
24 months
|
|
Overall survival timeToxicity profile (according to NCI CTCAE v3)
Time Frame: 24 months
|
24 months
|
|
Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Young Suk Park, M.D.,Ph.D., Samsung medical center, Seoul, Korea
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Cetuximab
Other Study ID Numbers
- 2008-04-018
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