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Tarceva. ICORG 08-41

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ClinicalTrials.gov Identifier: NCT01721252
Recruitment Status : Completed
First Posted : November 5, 2012
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief Summary:

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 or disease
Non-small Cell Lung Cancer

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.


Study Type : Observational
Actual Enrollment : 200 participants
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
Study Start Date : December 2009
Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. 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. ]
    Routine CT with RECIST/WHO assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Cancer Trials Ireland

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT01721252     History of Changes
Other Study ID Numbers: ICORG 08-41
First Posted: November 5, 2012    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Keywords provided by Cancer Trials Ireland:
non-small cell lung cancer
Erlotinib
TarcevaTM
proteomic signature

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