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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Non-Small Cell Lung Cancer

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Trial Information

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


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


Inclusion Criteria:



1. Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC
with wild-type KRAS and not a candidate for metastectomy.

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.

6. Must have at least 1 unidimensional measurable lesion

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Correlation between the type and degree of reported skin and/or eye reaction and the SNP profile of the EGFR domain III region.

Outcome Description:

Using Common Terminology Criteria for Adverse Events (CTCAE) version 4

Outcome Time Frame:

Throughout treatment with up to 5 years in follow up

Safety Issue:

Yes

Authority:

Ireland: Health Information and Quality Authority

Study ID:

ICORG 08-40

NCT ID:

NCT01726309

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms

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