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

NCT00883480 | Completed

• 1 other identifier: SLAT
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  From the date of randomization to the date of last follow up or death, assessed up to 24 months

Study Arms (2)

2

EXPERIMENTAL

The rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel

Drug: Docetaxel; Drug: Cisplatin; Drug: Gemcitabine

1

EXPERIMENTAL

The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor

Drug: Erlotinib

Interventions

Docetaxel DRUG

Docetaxel 75 mg/day 1 x 4 cycles

Also known as: Taxotere

2

Cisplatin DRUG

Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles

Also known as: Platinol

2

Gemcitabine DRUG

Cisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles

Also known as: Gemzar

2

Erlotinib DRUG

Erlotinib 150 mg/day x 21 days

Also known as: Tarceva

1

Eligibility Criteria

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

You may qualify if:

• 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 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..

You may not qualify if:

• Severe comorbidity.

Sponsors & Collaborators

• Spanish Lung Cancer Group: lead

Study Sites (2)

Ico-Hospital Universitarios Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Carlos Haya

Málaga, Málaga, Spain

Location

Related Publications (1)

• 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.

  PMID: 19415121 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin; Gemcitabine; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rafael Rosell, MD

  ICO-HOSPITAL GERMANS TRIAS I PUJOL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: April 17, 2009
• Study Start: June 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 28, 2026

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)