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Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

Primary Purpose

Colorectal Cancer, Unresectable Liver Metastasis

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

FOLFOX6/cetuximab

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Unresectable liver metastasis, FOLFOX6, Cetuximab, Neoadjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEO

Arm Description

NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab

Outcomes

Primary Outcome Measures

To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis

Secondary Outcome Measures

Response rate (according to RECIST)

Progression-free survival time

Overall survival timeToxicity profile (according to NCI CTCAE v3)

Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival

Full Information

NCT ID

NCT00743678

First Posted

August 27, 2008

Last Updated

June 13, 2013

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00743678

Brief Title

Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

Official Title

A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Unresectable Liver Metastasis

Keywords

Colorectal Cancer, Unresectable liver metastasis, FOLFOX6, Cetuximab, Neoadjuvant therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NEO

Arm Type

Experimental

Arm Description

NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab

Intervention Type

Drug

Intervention Name(s)

FOLFOX6/cetuximab

Intervention Description

Neoadjuvant FOLFOX6/cetuximab

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Response rate (according to RECIST)

Time Frame

24 months

Title

Progression-free survival time

Time Frame

24 months

Title

Overall survival timeToxicity profile (according to NCI CTCAE v3)

Time Frame

24 months

Title

Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young Suk Park, M.D.,Ph.D.

Organizational Affiliation

Samsung Medical Center, Seoul, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

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