Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

Retrospective Study Assessing Molecular Features Predicting Response or Resistance to Cetuximab Therapy in Metastatic Colorectal Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00491140

Enrollment

Registered

2007-06-25

Start date

2006-12-31

Completion date

2008-06-30

Last updated

2008-10-01

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

Conditions

Colorectal Neoplasms

Keywords

EGFR, KRAS, BRAF, MET, IGFR1

Brief summary

The primary objective is to identify molecular features predicting response or resistance to cetuximab

Detailed description

Secondary objective is to investigate association of genomic status of EGFR and HER-2 genes with clinical outcome, including objective response, time to progression and survival

Interventions

GENETICGene mutations analysis and FISH

FISH and mutation analysis of multiple genes

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed diagnosis of colorectal cancer with available tumor tissue and clinical data; presence of at least one measurable lesion.

Exclusion criteria

* Less than 3 weeks after completion of previous radiotherapy

Design outcomes

Primary

Measure	Time frame
Association of different biomarkers with Cetuximab sensitivity	Assessment every two months

Secondary

Measure	Time frame
Association of different biomarkers with time to progression and survival	At the end of the study

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026