Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab

Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by obtaining a level of sensitivity down to single tumor cells without compromising specificity. This allows assessment of multiple TKI treatment targets, their activation status, as well as down stream signaling proteins using very tiny amount of tissue that can be obtained by FNA or CTCs.

We planned this study to explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor changes in the RTK activation status during cetuximab treatment using circulating tumor cells and analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with histologically confirmed metastatic colorectal cancer
Cetuximab-based chemotherapy (monotherapy, combination therapy with cytotoxic chemotherapy such as FOLFOX, XELOX, irinotecan, FOLFIRI, XELIRI, first-line, second-line or third-line are all eligible)
Age > 18 years.
ECOG Performance Status of 0-2
Adequate bone marrow, liver and renal function
Signed and dated informed consent before the start of specific protocol procedures.
FNA will be performed in patients with feasible biopsy site; ascites or pleural fluid will be collected in metastatic CRC patients with ascites or pleural effusion

Exclusion criteria

Active clinically serious infections (> grade 2 CTCAE version 3.0)
Patients with evidence or history of bleeding diathesis
Radiotherapy during study or within 4 weeks of start of study drug.
Prior exposure to the study drug.
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Treatment and study plan

Primary outcomes

To explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform

Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)

A. To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells B. To identify negative predictive markers to cetuximab

Secondary outcomes

1. RTK activation status during cetuximab treatment using circulating tumor cells

Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)
2. signal transduction pathway attributable to cetuximab resistance

Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and EOT (end of treatment)
3. To analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab

Time frame: at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months (end of treatment)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Jan 7, 2014
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed