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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00050973 |
This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: bexarotene |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer |
Enrollment: | 623 |
Study Completion Date: | March 2005 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
This study evaluates the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients must have:
Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
Patients must not have had:
Study Director: | Mack Mabry, M.D. | Ligand Pharmaceuticals |
Study ID Numbers: | L1069-49 |
Study First Received: | December 31, 2002 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00050973 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NSCLC Targretin Retinoid Bexarotene |
Anticarcinogenic Agents Thoracic Neoplasms Vinorelbine Cisplatin Respiratory Tract Diseases Bexarotene |
Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Anticarcinogenic Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Protective Agents Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Bexarotene Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |