Single Nucleotide Polymorphism(SNP)Study
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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 |
- 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
- 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: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Stage IV CRC |
| Stage IV NSCLC |
Detailed Description:
Baseline assessment:
- Karnofsky Performance status
- Presence of any pre-existing skin condition
- Routine haematology
- Biochemistry
- Carcinoembryonic Antigen (CEA) measurement
- Computed tomography (CT) imaging to assess baseline disease extent using TNM Staging
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 characterised.
Follow-up Assessment: with every second cycle of Cetuximab- or Panitumumab-containing regimen (CRC: every 2. Week; NSCLC: every 3-4 weeks):
- Assessment of skin and eye toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version 4
- Haematology
- Biochemistry
- 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.
- TTP
- OS
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
Inclusion Criteria:
- Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC with wild-type KRAS and not a candidate for metastectomy.
- Stage IV (AJCC 7th Edition, TMN Staging, Appendix C) NSCLC expressing EGFR (IHC tested)
- Patients, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
- Karnofsky performance status (Appendix B) score ≥60.
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.
- Must have at least 1 unidimensional measurable lesion
Exclusion Criteria:
- Aged < 18 years
- Prior exposure to Cetuximab or Panitumumab
- The CRC does not carry wild-type KRAS.
- The NSCLC stains negative for EGFR protein expression
- Second cancer diagnosis (apart from non-melanoma skin cancer)
- Known hypersensitivity to Cetuximab or Panitumumab, or murine protein.
- 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).
- Known to be pregnant (pregnancy test is not mandatory) or breast-feeding.
Contacts and Locations| Ireland | |
| Bon Secours Hospital | Recruiting |
| Cork, Ireland | |
| Contact: Contact person 021-4542807 | |
| Cork University Hospital | Recruiting |
| Cork, Ireland | |
| Contact: Contact person 021-4546400 | |
| The Adelaide & Meath Hosptal, Dublin Incorporating The National Children's Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Contact Person (01) 414 2000 | |
| Beaumont Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Contact Person 01-8093000 | |
| Galway University Hospital | Recruiting |
| Galway, Ireland | |
| Contact: Contact person 091-524222 | |
| Our Lady of Lourdes Hospital, Drogheda | Recruiting |
| Louth, Ireland | |
| Contact: Contact Person (041) 9837601 | |
| Sligo Gerneral Hospital | Recruiting |
| Sligo, Ireland | |
| Contact: Contact Person 071-9171111 | |
| Waterford Regional Hospital | Recruiting |
| Waterford, Ireland | |
| Contact: Contact Person 051-848000 | |
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: | November 9, 2012 |
| 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 May 16, 2013