Overview

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

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Spanish Lung Cancer Group
Treatments:
Cisplatin
Docetaxel
Erlotinib Hydrochloride
Gemcitabine
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.