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Sponsored by: |
Spanish Lung Cancer Group |
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Information provided by: | Spanish Lung Cancer Group |
ClinicalTrials.gov Identifier: | NCT00617656 |
Primary objective:
· Time to progression.
Secondary objectives:
Condition | Intervention | Phase |
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Lung Cancer |
Drug: Cisplatin, Docetaxel Drug: Gemcitabine, Cisplatin Drug: Docetaxel, Cisplatin Drug: Docetaxel |
Phase III |
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) |
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 |
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A: Active Comparator
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
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Drug: Cisplatin, Docetaxel
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
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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
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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
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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
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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
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B3: Experimental
High levels of BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
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Drug: Docetaxel
Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with the following hematologic values:
ANC >= 1.5 x 109/L Hb >= 10 g/dl Platelets ³ 100 x 109/L
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.
Exclusion Criteria:
Contact: JOSÉ A ROMERO CARNERERO | 34917081250 | joseantonio.romero@pivotal.es |
Spain, BARCELONA | |
H. Germans Trias i Pujol | Recruiting |
Badalona, BARCELONA, Spain, 08916 | |
Principal Investigator: Rafael R Rosell Costa, MD |
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 |
LUNG CANCER |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Carcinoma |
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 |