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Multicenter, Predictive, Prospective, Phase III, Open, Randomized, Pharmacogenomic Study in Patients With Advanced Lung Carcinoma (BREC)
This study is currently recruiting participants.
Verified by Spanish Lung Cancer Group, February 2008
Sponsored by: Spanish Lung Cancer Group
Information provided by: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT00617656
  Purpose

Primary objective:

· Time to progression.

Secondary objectives:

  • Assess Overall survival of both treatment groups.
  • Assess Tumor response rate using RECIST criteria
  • Assess Toxicity profile of patients enrolled in the study.
  • Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.

Condition Intervention Phase
Lung Cancer
Drug: Cisplatin, Docetaxel
Drug: Gemcitabine, Cisplatin
Drug: Docetaxel, Cisplatin
Drug: Docetaxel
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel Cisplatin Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: MULTICENTER, PHASE III, RANDOMIZED STUDY TO EVALUATE TREATMENT CUSTOMIZED ACCORDING BRCA1 ASSESSMENT IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG CANCER. BREC STUDY (BRCA1 EXPRESSION CUSTOMIZATION)

Further study details as provided by Spanish Lung Cancer Group:

Primary Outcome Measures:
  • Time to progression [ Time Frame: time until death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess Overall survival of both treatment groups. [ Time Frame: time until death ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 768
Study Start Date: February 2008
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
Drug: Cisplatin, Docetaxel
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
B1: Experimental
Low levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Drug: Gemcitabine, Cisplatin
Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
B2: Experimental
Intermediate levels of BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
Drug: Docetaxel, Cisplatin
Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
B3: Experimental
High levels of BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Drug: Docetaxel
Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Detailed Description:

Study population:

Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria).

Duration of treatment:

Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator.

Calendar and planned finalization date:

The approximate duration of the study is 2 years of recruitment followed by 1 year of follow-up.

  Eligibility

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

Inclusion Criteria:

  1. Patients age 18 years or more.
  2. Histologically confirmed diagnosis of non-small-cell lung carcinoma.
  3. Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
  4. Tumor sample available (minimum of three 5-µm slices or tumor area 5-7 mm2).
  5. A measurable lesion, as defined by RECIST criteria.
  6. Karnofsky score 60% or more (ECOG<2).
  7. 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.
  8. Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
  9. Patients with the following hematologic values:

    ANC >= 1.5 x 109/L Hb >= 10 g/dl Platelets ³ 100 x 109/L

  10. Patients with the following biochemical values:

    Bilirubin <= 1.0 mg/dL AST and ALT < 1.5 upper limit of normality Creatinine clearance >= 60 ml/min.

  11. 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.
  12. 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.
  13. Patients must be available for clinical follow-up.

Exclusion Criteria:

  1. Previous chemotherapy treatment.
  2. Patients diagnosed of another neoplasm, with the exception of cervix carcinoma in situ, treated squamous cell carcinomas or superficial bladder tumors (Ta and TIS), or other malignant tumors that have received curative treatment at least 5 years before inclusion in the study.
  3. Patients with active bacterial or fungal infective processes qualified clinically as serious (>= grade 2 of NCI-CTC, Version 3).
  4. Patients who have received an investigational medicinal product in the 21 days before inclusion in the study.
  5. Patients with HIV infection, HCV infection, uncontrolled coronary disease or arrhythmia, uncontrolled cerebrovascular disease and other clinical conditions that, in the judgment of the investigator, contraindicate the patient's participation in the study.
  6. Patients who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test performed within 7 days before the onset of treatment.
  7. Substance abuse, clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance.
  8. Patients who present any contraindication or suspected allergy to the products under investigation in the study
  9. Impossibility to comply with chemotherapy treatment due to cultural or geographic circumstances.
  10. Significant weight loss (>= 10% of body weight) in the 6 weeks before inclusion in the study.
  11. Any condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study.
  12. Contraindication for steroid use.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617656

Contacts
Contact: JOSÉ A ROMERO CARNERERO 34917081250 joseantonio.romero@pivotal.es

Locations
Spain, BARCELONA
H. Germans Trias i Pujol Recruiting
Badalona, BARCELONA, Spain, 08916
Principal Investigator: Rafael R Rosell Costa, MD            
Sponsors and Collaborators
Spanish Lung Cancer Group
  More Information

SPANISH LUNG CANCER GROUP  This link exits the ClinicalTrials.gov site

Responsible Party: GECP ( Rafael Rosell Costa )
Study ID Numbers: GECP-BREC, 2007-004278-20
Study First Received: February 5, 2008
Last Updated: February 6, 2008
ClinicalTrials.gov Identifier: NCT00617656  
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Lung Cancer Group:
LUNG CANCER

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009