NCT01356368

Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer

A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: National Guard Health Affairs · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole. The results of this pilot study will help in designing more definitive trials in our patient population.

Detailed description

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin, Gemzar, Docetaxel, Alimta	Patients will be assigned to treatment according to the molecular biological results which will analyze excision repair cross-complementing (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and beta-tubulin genes in primary tumor cells which are present in tissues and peripheral blood.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-05-19
• Last updated: 2014-01-22

Locations

1 site across 1 country: Saudi Arabia