Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02029326

Enrollment

Registered

2014-01-07

Start date

2010-02-01

Completion date

2015-08-26

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal cancer, cetuximab, biomarker, prometheus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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)

Countries

South Korea

Outcome results