Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab - Full Text View

Sponsored by:	Istituto Clinico Humanitas
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00491140

Purpose

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

Condition	Intervention
Colorectal Neoplasms	Genetic: Gene mutations analysis and FISH

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Retrospective Study Assessing Molecular Features Predicting Response or Resistance to Cetuximab Therapy in Metastatic Colorectal Cancer Patients

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:

Association of different biomarkers with Cetuximab sensitivity [ Time Frame: Assessment every two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Association of different biomarkers with time to progression and survival [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Paraffine embedded tumor sections

Enrollment:	85
Study Start Date:	December 2006
Study Completion Date:	June 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Observation Colorectal cancer patients	Genetic: Gene mutations analysis and FISH FISH and mutation analysis of multiple genes

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Colorectal cancer patients treated with Cetuximab

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491140

Locations

Italy, Milan
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Study Director:

Armando Santoro, MD

Istituto Clinico Humanitas

More Information

Publications:

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. Epub 2005 Jan 27.

Responsible Party:	Istituto Clinico Humanitas ( Dr. Armando Santoro )
Study ID Numbers:	ICH n. 380
Study First Received:	June 22, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00491140
Health Authority:	Italy: Ministry of Health

Keywords provided by Istituto Clinico Humanitas:

EGFR
KRAS
BRAF
MET
IGFR1

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Cetuximab
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 09, 2009