Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"

Carcinoma, Non-Small-Cell Lung Clinical Trial

— Pharmacogenos  

Official title:

Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222404
• Other study ID #: DCIC 04 40
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: November 4, 2010
• Start date: July 2005
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to correlate molecular genetic profile with response to chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.

Description:

Lung carcinoma will be the fifth death cause in the world in 2020. In Europe it causes more deaths than carcinoma of breast, colon and prostate combined so it is a public healthcare priority. Applying high throughput molecular analysis technologies to pharmacogenomics could improve lung carcinoma care strategies. The study hypothesis is that the determination of the genomic and proteomic profiles of non-small cell lung carcinoma patients will allow treatment targeting , improving treatment efficacy and tolerance.

In order to carry out this study, the five thoracic oncology centers of the Rhône-Alpes region will collaborate with several INSERM (French national research institute) units and new biotechnology companies.

The primary objective of this study is to correlate molecular genetic profile with response to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung carcinomas.

Biological samples will be collected before and during patient care to correlate clinical evolution (response and tolerance) with:

• circulating cell polymorphism profile

• proteomic profile

• genetic and epigenetic modifications of genes involved in DNA repair, drugs metabolism, apoptosis cell regulation mechanisms, and cell mobility and adhesion mechanisms.

The main judgment criteria will be response to chemotherapy correlated with patient's biological profile.

Second judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy.

The second purpose of this study is to validate less invasive methods of sampling using blood, expectoration, urine, fixed biopsies and lungs tapping, as a substitute to the current reference (frozen tumor), which is out of reach in clinical examination.

This will contribute to setting of a multicentric resources bank, to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies.

Two previous studies (1800 and 500 patients respectively) have already been carried out, data and samples are available.

For this study, 600 patients will be included over 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma

• Patient treated by chemotherapy with platinum salt

• Every stage TNM classification

• No previous chemotherapy

• One measurable lesion out of nervous central system at least

• Performance status from 0 to 2 on ECOG scale

• Life expectancy > 12 weeks

Exclusion Criteria:

• Previous or Concomitant carcinoma over 5 last years

• Concomitant radiotherapy

• Cardiac disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Beer DG, Kardia SL, Huang CC, Giordano TJ, Levin AM, Misek DE, Lin L, Chen G, Gharib TG, Thomas DG, Lizyness ML, Kuick R, Hayasaka S, Taylor JM, Iannettoni MD, Orringer MB, Hanash S. Gene-expression profiles predict survival of patients with lung adenocarcinoma. Nat Med. 2002 Aug;8(8):816-24. Epub 2002 Jul 15. — View Citation

Dumontet C, Morschhauser F, Solal-Celigny P, Bouafia F, Bourgeois E, Thieblemont C, Leleu X, Hequet O, Salles G, Coiffier B. Gemcitabine as a single agent in the treatment of relapsed or refractory low-grade non-Hodgkin's lymphoma. Br J Haematol. 2001 Jun;113(3):772-8. — View Citation

Dumontet C, Sikic BI. Mechanisms of action of and resistance to antitubulin agents: microtubule dynamics, drug transport, and cell death. J Clin Oncol. 1999 Mar;17(3):1061-70. Review. — View Citation

Galmarini CM, Mackey JR, Dumontet C. Nucleoside analogues and nucleobases in cancer treatment. Lancet Oncol. 2002 Jul;3(7):415-24. Review. — View Citation

Howard BA, Wang MZ, Campa MJ, Corro C, Fitzgerald MC, Patz EF Jr. Identification and validation of a potential lung cancer serum biomarker detected by matrix-assisted laser desorption/ionization-time of flight spectra analysis. Proteomics. 2003 Sep;3(9):1720-4. — View Citation