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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

ClinicalTrials.gov processed this record on September 18, 2014