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Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

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ClinicalTrials.gov Identifier: NCT00491140
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : October 1, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The primary objective is to identify molecular features predicting response or resistance to cetuximab

Condition or disease Intervention/treatment
Colorectal Neoplasms Genetic: Gene mutations analysis and FISH

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

Study Design

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study Assessing Molecular Features Predicting Response or Resistance to Cetuximab Therapy in Metastatic Colorectal Cancer Patients
Study Start Date : December 2006
Primary Completion Date : May 2007
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Observation
Colorectal cancer patients
Genetic: Gene mutations analysis and FISH
FISH and mutation analysis of multiple genes


Outcome Measures

Primary Outcome Measures :
  1. Association of different biomarkers with Cetuximab sensitivity [ Time Frame: Assessment every two months ]

Secondary Outcome Measures :
  1. Association of different biomarkers with time to progression and survival [ Time Frame: At the end of the study ]

Biospecimen Retention:   Samples With DNA
Paraffine embedded tumor sections

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491140


Locations
Italy
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:
Responsible Party: Dr. Armando Santoro, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00491140     History of Changes
Other Study ID Numbers: ICH n. 380
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: September 2008

Keywords provided by Istituto Clinico Humanitas:
EGFR
KRAS
BRAF
MET
IGFR1

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents