Overview

This trial is active, not recruiting.

Conditions liver metastasis, colorectal cancer
Treatments bevacizumab, cetuximab, l-ohp, l-lv, 5-fu
Targets EGFR, VEGF
Sponsor EPS Corporation
Start date May 2013
End date May 2017
Trial size 100 participants
Trial identifier NCT01834014, ATOM Exploratory study, UMIN000010429

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mFOLFOX plus bevacizumab
bevacizumab Avastin
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.
l-ohp Oxaliplatin
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.
l-lv Levofolinate
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.
5-fu Fluorouracil
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.
5-fu Fluorouracil
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.
(Active Comparator)
mFOLFOX plus cetuximab
cetuximab Erbitux
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.
l-ohp Oxaliplatin
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.
l-lv Levofolinate
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.
5-fu Fluorouracil
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.
5-fu Fluorouracil
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.

Primary Outcomes

Measure
To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)
time frame: Baseline, Cycle 8, Progression Disease

Secondary Outcomes

Measure
To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events
time frame: Baseline, Cycle 8, Progression Disease
Progression-free survival among the RAS wild type subpopulation
time frame: assessed every 8 weeks, up to 4 years
Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma
time frame: Baseline, Cycle 8, Progression Disease

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: - Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment. Exclusion Criteria:

Additional Information

Official title 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
Principal investigator Ichinosuke Hyodo, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by EPS Corporation.