A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers
The treatment of advanced NSCLC cancer includes various chemotherapies with equivalent
regimens that have reached a therapeutic plateau. The selection of these regimens is
completely empirical and physician dependent. Potential predictors of specific agent
efficacy exist in the form of tumor molecular markers that are a reflection of the
individual's genetic make up. Thus our study aims at utilizing these markers to more
efficiently select the regimen in order to maximize the benefit to the patients rather than
using empiric approaches. Fortunately, each of our selected regimens contains active and
well-studied agents in the treatment of lung cancer (Table 1). This pilot study will help
us determine the benefit, and safety of this approach (not individual regimen). The study
is not to compare individual regimens but it aims at testing the whole concept of
customization of chemotherapy based on molecular markers to help us in the future at
selecting regimens based on these markers and not empirically. The results then will be used
to determine more definitive future studies.
Furthermore, circulating tumor cells in the blood represent the future distant metastases
that result in disease progression to incurable stages. The circulating tumor cells have the
ability to cross into vessels, travel in circulation, and exit the vessels into tissues
where they have the capability to grow. Therefore, these cells may express different
biological and molecular features from the stationary cells in the primary tumors.
Therefore, exploiting these circulating tumor cells for augmenting treatment approaches is
of vital importance and utility.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy and Safety
Efficacy is measured by: overall response rate (partial response and complete response) using RECIST Criteria time to disease progression (TTP) progression free survival (PFS) overall survival (OS) To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 5 parameters to be collected for all patients who receive the study regimen which are: Adverse Events Laboratory Assessments Vital Signs Physical Examinations ECG
3 years
Yes
Abdulrahman Jazieh, MD/MPH
Principal Investigator
King Abdul Aziz Medical City for National Guard
Saudi Arabia: Ethics Committee
RC09/095
NCT01356368
May 2010
May 2013
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