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

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

This study has been completed.

First Received: December 22, 2008 Last Updated: April 16, 2009 History of Changes

Sponsored by:	Spanish Lung Cancer Group
Information provided by:	Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:	NCT00883480

Purpose

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

Condition	Intervention
Non-Small Cell Lung Cancer	Drug: Docetaxel Drug: Docetaxel-Cisplatin Drug: Gemcitabine-Cisplatin Drug: Erlotinib

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Docetaxel Gemcitabine hydrochloride Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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

Further study details as provided by Spanish Lung Cancer Group:

Primary Outcome Measures:

Tumoral Response (RECIST criteria)

Secondary Outcome Measures:

Overall Survival [ Time Frame: 2 years ]

Enrollment:	153
Study Start Date:	June 2005
Study Completion Date:	November 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883480

Locations

Spain
Hospital Carlos Haya
Málaga, Spain
Spain, Barcelona
Ico-Hospital Universitarios Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916

Sponsors and Collaborators

Spanish Lung Cancer Group

Investigators

Study Chair:

Rafael Rosell, Phd

ICO-HOSPITAL GERMANS TRIAS I PUJOL

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Spanish Lung Cancer Group ( Rafael Rosell )
Study ID Numbers:	SLAT
Study First Received:	December 22, 2008
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00883480 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Spanish Lung Cancer Group:

NSCLC

Study placed in the following topic categories:

Antimetabolites
Erlotinib
Thoracic Neoplasms
Immunologic Factors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Docetaxel
Radiation-Sensitizing Agents

Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Mitogens
Adenocarcinoma
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses

Gemcitabine
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009