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

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ClinicalTrials.gov Identifier: NCT01726309
Recruitment Status : Active, not recruiting
First Posted : November 14, 2012
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Tracking Information
First Submitted Date November 9, 2012
First Posted Date November 14, 2012
Last Update Posted Date February 26, 2020
Study Start Date May 2011
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2012)
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 ]
Using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 9, 2012)
Correlation between the SNP profile(s) and disease response [ Time Frame: Throughout treatment with up to 5 years in follow up ]
Time to progression TTP and OS over 5 years
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4
Official Title Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin Toxicity and Disease Response to Treatment With Erbitux Requirements
Brief Summary

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.

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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).

Condition
  • Colorectal Cancer
  • Non-Small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Stage IV CRC
  • Stage IV NSCLC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 9, 2012)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01726309
Other Study ID Numbers ICORG 08-40
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor Cancer Trials Ireland
Collaborators Not Provided
Investigators Not Provided
PRS Account Cancer Trials Ireland
Verification Date February 2020