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

NCT01356368 | Terminated Phase 2

• 1 other identifier: RC09/095
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy and Safety

  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

  3 years

Secondary Outcomes (1)

• Tumor marker

  3 years

Study Arms (1)

Cisplatin,Docetaxel,Gemzar, Premetrexed

EXPERIMENTAL

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

Interventions

Cisplatin, Gemzar, Docetaxel, Alimta DRUG

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.

Cisplatin,Docetaxel,Gemzar, Premetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
• Having adequate tissue sample to perform the markers testing
• Age ≥ 18 years
• No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
• No other concurrent cancer treatment
• Performance status of 0- 2 per ECOG scale (Appendix II)
• 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
• Presence of measurable disease

You may not qualify if:

• Prior systemic treatment for lung cancer
• History of hypersensitivity to drugs used
• Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
• Medical illness that puts the patient at significant risk per investigator's discretion
• 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
• Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)

Sponsors & Collaborators

• National Guard Health Affairs: lead

Study Sites (1)

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Cisplatin; Gemcitabine; Docetaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Abdulrahman Jazieh, MD/MPH

  King Abdul Aziz Medical City for National Guard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2011
• First Posted: May 19, 2011
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

SA (1)