Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab

February 20, 2017 updated by: Joon Oh Park, Samsung Medical Center

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

colorectal cancer patients who are treated with cetuximab

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

August 26, 2015

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

January 5, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-09-074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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