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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174629 |
Primary Objective:
Secondary Objective:
Condition | Intervention | Phase |
---|---|---|
Lung Neoplasms |
Drug: Docetaxel/DDP Drug: docetaxel/gemcitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Cooperative, Randomized, Multicenter Phase III Study on the Use of Cisplatin Resistant Genotype (ERCC1 Over-Expression) in Tumor RNA to Customize Chemotherapy in Stage IV-IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer Patients |
Enrollment: | 449 |
Study Start Date: | June 2001 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: docetaxel/gemcitabine |
2: Active Comparator | Drug: Docetaxel/DDP |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be/have:
Adequate bone marrow, hepatic and renal functions, assessed during the previous 14 days, that should be shown by the following characteristics:
previous radiotherapy is allowed if:
Exclusion Criteria:
other serious illness or medical condition, including:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Germany | |
Sanofi-Aventis | |
Berlin, Germany | |
Spain | |
Sanofi-Aventis | |
Barcelona, Spain | |
Switzerland | |
Sanofi-Aventis | |
Genève, Switzerland |
Study Director: | Jean-Philippe Aussel | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | TAX.ES1.302 |
Study First Received: | September 9, 2005 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00174629 |
Health Authority: | Spain: Spanish Agency of Medicines |
Thoracic Neoplasms Non-small cell lung cancer Pleural Diseases Pleural Effusion, Malignant Carcinoma Docetaxel Pleural Effusion Cisplatin |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Pleural Neoplasms |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type 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 |