Tarceva. ICORG 08-41

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01721252
First received: October 24, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy.

This is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.


Condition
Non-small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of a Proteomic Signature Developed to Identify Patients Likely to Benefit From Erlotinib (TarcevaTM), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Used in the Treatment of Non-small Cell Lung Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Value of a recently identified proteomic algorithm [ Time Frame: Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression. ] [ Designated as safety issue: No ]
    Routine CT with RECIST/WHO assessment


Estimated Enrollment: 200
Study Start Date: December 2009
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Screening/Baseline

  1. Routine blood tests (Haematology and Biochemistry) as per hospital practice
  2. Research serum sample for proteomic studies (10ml blood sample)
  3. Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size

2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment

4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment

1 year Post Commencement of Treatment with erlotinib (as per current standard of care): Routine CT with RECIST/WHO assessment

Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.

Follow Up: Subsequent follow-up as per routine.

  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

Any patient (18 years of age or older) diagnosed with non-small cell lung cancer at any stage who is to be treated with erlotinib.

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Any patient who is suited to receive CT scans as part of his/her routine care
  • Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures
  • Planned treatment with erlotinib.

Exclusion Criteria:

  • Patients younger than 18 years of age
  • Patients not foreseen to receive TarcevaTM treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721252

Locations
Ireland
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
St James Hospital
Dublin, Ireland
The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Mid-Western Regional Hospital
Limerick, Ireland
Our Lady Of Lourdes Hospital, Drogheda
Louth, Ireland
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: NCT01721252     History of Changes
Other Study ID Numbers: ICORG 08-41
Study First Received: October 24, 2012
Last Updated: January 22, 2014
Health Authority: Ireland: Health Information and Quality Authority

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
non-small cell lung cancer
Erlotinib
TarcevaTM
proteomic signature

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014