Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356368
Recruitment Status : Terminated (slow accrual rate)
First Posted : May 19, 2011
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
National Guard Health Affairs

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Cisplatin, Gemzar, Docetaxel, Alimta Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers
Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cisplatin,Docetaxel,Gemzar, Premetrexed
Patients will receive treatment for up to six cycles of the assigned regimen unless there is disease progression or unacceptable toxicities. After treatment, the patients will be seen every 2 months for the first year, then every 3 months for the second year and every 6 months afterwards.
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.

Primary Outcome Measures :
  1. Efficacy and Safety [ Time Frame: 3 years ]
    1. 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)
    2. 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

Secondary Outcome Measures :
  1. Tumor marker [ Time Frame: 3 years ]
    1. The molecular characteristics of circulating tumor cells harvested from peripheral blood
    2. Correlation between the markers of circulating tumor cells and primary tumor.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
  2. Having adequate tissue sample to perform the markers testing
  3. Age ≥ 18 years
  4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
  5. No other concurrent cancer treatment
  6. Performance status of 0- 2 per ECOG scale (Appendix II)
  7. Adequate laboratory values as follows as follows:

    Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤ 1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal level Serum creatinine ≤ 1.5 X institutional upper normal level

  8. Presence of measurable disease

Exclusion Criteria:

  1. Prior systemic treatment for lung cancer
  2. History of hypersensitivity to drugs used
  3. Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
  4. Medical illness that puts the patient at significant risk per investigator's discretion
  5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids
  6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)

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 identifier (NCT number): NCT01356368

Layout table for location information
Saudi Arabia
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, Saudi Arabia
Sponsors and Collaborators
National Guard Health Affairs
Layout table for investigator information
Principal Investigator: Abdulrahman Jazieh, MD/MPH King Abdul Aziz Medical City for National Guard
Layout table for additonal information
Responsible Party: National Guard Health Affairs Identifier: NCT01356368    
Other Study ID Numbers: RC09/095
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by National Guard Health Affairs:
Lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action