Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01726309
First received: November 9, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

Primary Objective:

Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region.

Secondary Objectives:

Correlation of SNP profile with indicators of tumour response parameters, such as radiological response, duration of response, time to progression (TTP), overall survival (OS) time, incidence of non-dermatological adverse events.


Condition
Colorectal Cancer
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin and/or Eye Toxicity and Disease Response to Treatment With Cetuximab or Panitumumab - SNP and Cetuximab or Panitumumab Response

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Correlation between the type and degree of reported skin and/or eye reaction and the SNP profile of the EGFR domain III region. [ Time Frame: Throughout treatment with up to 5 years in follow up ] [ Designated as safety issue: Yes ]
    Using Common Terminology Criteria for Adverse Events (CTCAE) version 4


Secondary Outcome Measures:
  • Correlation between the SNP profile(s) and disease response [ Time Frame: Throughout treatment with up to 5 years in follow up ] [ Designated as safety issue: No ]
    Time to progression TTP and OS over 5 years


Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stage IV CRC
Stage IV NSCLC

Detailed Description:

Baseline assessment:

  • Contact Lenses
  • Medical History
  • Previous chemotherapy
  • Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure)
  • Symptom Assessment (Pre-existing skin and/or eye conditions, CEA measurement (CRC only), Disease status (TNM Staging))
  • Planned chemotherapy regimen
  • Radiotherapy

Blood Sample: A 2ml blood sample should be collected in ethylenediamine-tetraacetic acid (EDTA) containing Vacutainer at any time before or after starting treatment. DNA will be extracted from the samples and the 11 SNPs in the region of the EGFR gene encoding domain III will be characterized.

Follow-up Assessment: with every second cycle of Cetuximab- or Panitumumab-containing regimen (CRC: every 2. Week; NSCLC: every 3-4 weeks):

  • Visit Number and Date
  • Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure)
  • Symptom Assessment (CEA measurement (CRC only), Disease status (TMN Staging), Skin Toxicity (CTCAE) grading)
  • Current chemotherapy regimen
  • Radiotherapy
  • CEA measurement only for CRC (every second cycle/every 4 weeks)

Long-term follow-up (up to 5 years):

  • CT restaging (TNM Staging) should be done 3 monthly for as long as the subject is receiving Cetuximab- or Panitumumab- containing regimen or if there is suspicion of disease progression.
  • OS
  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

Patient Population:

150 Patients with histologically proven stage IV (AJCC 7th Edition) colorectal cancer (CRC) expressing wild-type KRAS or stage IV non-small cell lung cancer (NSCLC) expressing EGFR (tested by immunohistochemistry (IHC)), with no previous exposure to Cetuximab or Panitumumab, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).

Criteria

Inclusion Criteria:

  1. Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC with wild-type KRAS and not a candidate for metastasectomy.
  2. Stage IV (AJCC 7th Edition, TMN Staging, Appendix C) NSCLC expressing EGFR (IHC tested)
  3. Patients, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
  4. Karnofsky performance status (Appendix B) score ≥60.
  5. Acceptable laboratory values:

    • Haemoglobin ≥ 9 g/dL.
    • Neutrophil count ≥ 1.0 x 10^9/L.
    • Platelet count ≥100 x 10^9/L.
    • Serum creatinine ≤1.5 times the upper limit of normal.
    • Bilirubin ≤1.5 times the upper limit of normal.
    • Aspartate aminotransferase and alanine aminotransferase ≤5 times the upper limit of normal.

Exclusion Criteria:

  1. Aged < 18 years
  2. Prior exposure to Cetuximab or Panitumumab
  3. The CRC does not carry wild-type KRAS.
  4. The NSCLC stains negative for EGFR protein expression
  5. Second cancer diagnosis (apart from non-melanoma skin cancer)
  6. Known hypersensitivity to Cetuximab or Panitumumab, or murine protein.
  7. Known history of coronary artery disease, arrhythmias, or congestive heart failure (If the treating physician feels that a patient's coronary artery disease / arrhythmia / congestive heart failure does not place him/her at risk from treatment with an anti-EGFR antibody, the person can be included. This is a clinical decision, which has to be made by the treating physician).
  8. Known to be pregnant (pregnancy test is not mandatory) or breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726309

Locations
Ireland
Letterkenny General Hospital Recruiting
Letterkenny, Donegal, Ireland
Contact: Contact Person    074-9123798      
Principal Investigator: Karen Duffy, Dr         
Bon Secours Hospital Recruiting
Cork, Ireland
Contact: Contact person    021-4542807      
Principal Investigator: Brian Bird, Dr         
Cork University Hospital Recruiting
Cork, Ireland
Contact: Contact person    021-4546400      
Principal Investigator: Seamus O'Reilly, Dr         
The Adelaide & Meath Hosptal, Dublin Incorporating The National Children's Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    (01) 414 2000      
Principal Investigator: Ray McDermott, Dr         
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01-8093000      
Principal Investigator: Liam Grogan, Dr         
St Vincent's University Hospital Recruiting
Dublin, Ireland, 4
Contact: Contact Person    01-4142012      
Principal Investigator: Ray McDermott, Dr         
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland, 7
Contact: Contact Person    01-8545075      
Principal Investigator: David Gallagher, Dr         
Galway University Hospital Recruiting
Galway, Ireland
Contact: Contact person    091-524222      
Principal Investigator: Gregory Leonard, Dr         
Our Lady of Lourdes Hospital, Drogheda Recruiting
Louth, Ireland
Contact: Contact Person    (041) 9837601      
Principal Investigator: Bryan Hennessy, Dr         
Waterford Regional Hospital Recruiting
Waterford, Ireland
Contact: Contact Person    051-848000      
Principal Investigator: Anne Horgan, Dr         
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
  More Information

No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT01726309     History of Changes
Other Study ID Numbers: ICORG 08-40
Study First Received: November 9, 2012
Last Updated: August 11, 2014
Health Authority: Ireland: Health Information and Quality Authority

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 15, 2014