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

Non-small Cell Lung Cancer Clinical Trial

— SLAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883480
• Other study ID #: SLAT
• Status: Completed
• Phase: N/A
• Start date: June 2005
• Est. completion date: November 2008

Study information

• Verified date: June 2022
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Non-small Cell Lung Cancer

Intervention

Drug:
• Docetaxel
Docetaxel 75 mg/day 1 x 4 cycles
• Cisplatin
Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
• Gemcitabine
Cisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles
• Erlotinib
Erlotinib 150 mg/day x 21 days

Locations

Country	Name	City	State
Spain	Ico-Hospital Universitarios Germans Trias I Pujol	Badalona	Barcelona
Spain	Hospital Carlos Haya	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumoral Response (RECIST criteria)	To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1.	From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]
Secondary	Overall Survival	Time from randomization until death from any cause. Patients who have not died during the study will be tabulated on their last date of evaluation.	From the date of randomization to the date of last follow up or death, assessed up to 24 months

External Links

•   Web page of the sponsor where users can find more information about Fundación GECP studies