NCT01834014

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

An Exploratory Study to Evaluate Biomarkers as Predictive and /or Prognostic Factors of Benefit From Randomized Phase ll Study of mFOLFOX6+Bevacizumab or mFOLFOX6+Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: EPS Corporation · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Detailed description

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Conditions

• Liver Metastasis
• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2013-04-17
• Last updated: 2017-08-02

Locations

1 site across 1 country: Japan