Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029326
• Other study ID #: 2009-09-074
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: February 20, 2017
• Start date: February 1, 2010
• Est. completion date: August 26, 2015

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 26, 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	2. signal transduction pathway attributable to cetuximab resistance		at Screening (Day - 21 ~ 0 ), at 4 weeks and EOT (end of treatment)
Secondary	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)