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

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ClinicalTrials.gov Identifier: NCT00883480
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : April 17, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Drug: Docetaxel Drug: Docetaxel-Cisplatin Drug: Gemcitabine-Cisplatin Drug: Erlotinib

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Study Start Date : June 2005
Primary Completion Date : January 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 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


Outcome Measures

Primary Outcome Measures :
  1. Tumoral Response (RECIST criteria)

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883480


Locations
Spain
Ico-Hospital Universitarios Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Hospital Carlos Haya
Málaga, Spain
Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
Study Chair: Rafael Rosell, Phd ICO-HOSPITAL GERMANS TRIAS I PUJOL
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rafael Rosell, Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT00883480     History of Changes
Other Study ID Numbers: SLAT
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009

Keywords provided by Spanish Lung Cancer Group:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Docetaxel
Cisplatin
Erlotinib Hydrochloride
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents