Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab

NCT02029326 | Completed

• 1 other identifier: 2009-09-074
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer, cetuximab, biomarker, prometheus

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

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

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

• 2. signal transduction pathway attributable to cetuximab resistance

  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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

colorectal cancer patients who are treated with cetuximab

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: January 7, 2014
• Study Start: February 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: August 26, 2015
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

KR (1)