Clinical trial NCT00883480: Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
Official title: Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Spanish Lung Cancer Group
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Tumoral Response (RECIST criteria)
timeFrame: From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]
Secondary outcomes:
measure: Overall Survival
timeFrame: From the date of randomization to the date of last follow up or death, assessed up to 24 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Ico-Hospital Universitarios Germans Trias I Pujol
state: Barcelona
city: Málaga
country: Spain
facility: Hospital Carlos Haya
Study officials:
affiliation: ICO-HOSPITAL GERMANS TRIAS I PUJOL
name: Rafael Rosell, MD
role: STUDY_CHAIR
References:
citation: 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 Penas 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. doi: 10.1371/journal.pone.0005133. Epub 2009 May 5.