Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases

NACompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Liver MetastasisColorectal Cancer
Interventions
DRUG

Bevacizumab

5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

DRUG

Cetuximab

250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

DRUG

L-OHP

85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

DRUG

l-LV

200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

DRUG

5-FU

400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

DRUG

5-FU

2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

Trial Locations (1)

162-0814

EPS Corporation, Shinjuku-ku

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EPS Corporation

OTHER

NCT01834014 - Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases | Biotech Hunter | Biotech Hunter