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Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

NCT ID: NCT00491140

Last Updated: 2008-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Colorectal Neoplasms

Keywords

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EGFR KRAS BRAF MET IGFR1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observation

Colorectal cancer patients

Gene mutations analysis and FISH

Intervention Type GENETIC

FISH and mutation analysis of multiple genes

Interventions

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Gene mutations analysis and FISH

FISH and mutation analysis of multiple genes

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Istituto Clinico Humanitas

Principal Investigators

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Armando Santoro, MD

Role: STUDY_DIRECTOR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status

Countries

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Italy

References

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Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, Hamilton A, Pan D, Schrag D, Schwartz L, Klimstra DS, Fridman D, Kelsen DP, Saltz LB. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol. 2005 Mar 20;23(9):1803-10. doi: 10.1200/JCO.2005.08.037. Epub 2005 Jan 27.

Reference Type BACKGROUND
PMID: 15677699 (View on PubMed)

Other Identifiers

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ICH n. 380

Identifier Type: -

Identifier Source: org_study_id