Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma (SLAT)

This study has been completed.
Sponsor:
Information provided by:
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00883480
First received: December 22, 2008
Last updated: April 16, 2009
Last verified: April 2009

December 22, 2008
April 16, 2009
June 2005
January 2008   (final data collection date for primary outcome measure)
Tumoral Response (RECIST criteria)
Same as current
Complete list of historical versions of study NCT00883480 on ClinicalTrials.gov Archive Site
Overall Survival [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado

This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Non-Small Cell Lung Cancer
  • Drug: Docetaxel
    Docetaxel 75 mg/day 1 x 4 cycles
  • Drug: Docetaxel-Cisplatin
    Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
  • Drug: Gemcitabine-Cisplatin

    Cisplatin 75 mg/ day 1 x 4 cycles

    Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles

  • Drug: Erlotinib
    Erlotinib 150 mg/day x 21 days
Experimental: 1
Interventions:
  • Drug: Docetaxel
  • Drug: Docetaxel-Cisplatin
  • Drug: Gemcitabine-Cisplatin
  • Drug: Erlotinib
Rosell R, Perez-Roca L, Sanchez JJ, Cobo M, Moran T, Chaib I, Provencio M, Domine M, Sala MA, Jimenez U, Diz P, Barneto I, Macias JA, de Las Peñas R, Catot S, Isla D, Sanchez JM, Ibeas R, Lopez-Vivanco G, Oramas J, Mendez P, Reguart N, Blanco R, Taron M. Customized treatment in non-small-cell lung cancer based on EGFR mutations and BRCA1 mRNA expression. PLoS ONE. 2009;4(5):e5133. Epub 2009 May 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
November 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients age 18 years or more.
  • Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).

    • Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
    • Tumor sample available.
    • A measurable lesion, as defined by RECIST criteria.
    • Karnofsky score 60% or more (ECOG < 2).
    • Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
  • Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
  • Patients with hepatical, renal and hematology normality values.
  • Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
  • Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
  • Patients must be available for clinical follow-up..

Exclusion Criteria:

  • Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
  • Severe comorbidity.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00883480
SLAT
No
Rafael Rosell, Spanish Lung Cancer Group
Spanish Lung Cancer Group
Not Provided
Study Chair: Rafael Rosell, Phd ICO-HOSPITAL GERMANS TRIAS I PUJOL
Spanish Lung Cancer Group
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP