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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-11-30

Brief Summary

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

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Detailed Description

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

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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2

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

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Docetaxel 75 mg/day 1 x 4 cycles

Cisplatin

Intervention Type DRUG

Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles

Gemcitabine

Intervention Type DRUG

Cisplatin 75 mg/ day 1 x 4 cycles

Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles

1

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

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Erlotinib 150 mg/day x 21 days

Interventions

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Docetaxel

Docetaxel 75 mg/day 1 x 4 cycles

Intervention Type DRUG

Cisplatin

Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles

Intervention Type DRUG

Gemcitabine

Cisplatin 75 mg/ day 1 x 4 cycles

Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles

Intervention Type DRUG

Erlotinib

Erlotinib 150 mg/day x 21 days

Intervention Type DRUG

Other Intervention Names

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Taxotere Platinol Gemzar Tarceva

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No