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Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

This study has been completed.
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00491140
First received: June 22, 2007
Last updated: September 30, 2008
Last verified: September 2008
History of Changes
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

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

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
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
Study First Received: June 22, 2007
Last Updated: September 30, 2008
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on June 18, 2013