Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT02029326
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-02-01
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2014-01-05
• Study First Posted: 2014-01-07
• Primary Completion: 2015-01
• Study Completion: 2015-08-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
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)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of