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Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Phase 3
Completed
Conditions
Non-small Cell Lung Cancer
Registration Number
NCT00050973
Lead Sponsor
Eisai Inc.
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
623
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (77)

Brookwood Medical Center

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

Southern Arizona VA Healthcare System

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Arroyo Research Inc.

πŸ‡ΊπŸ‡Έ

Pasadena, California, United States

Desert Hematology-Oncology Medical Group, Inc.

πŸ‡ΊπŸ‡Έ

Rancho Mirage, California, United States

University of Florida

πŸ‡ΊπŸ‡Έ

Gainsville, Florida, United States

New Hope Cancer Center

πŸ‡ΊπŸ‡Έ

Hudson, Florida, United States

Veterans Affairs Medical Center

πŸ‡ΊπŸ‡Έ

Miami, Florida, United States

Bay Area Cancer Consultants

πŸ‡ΊπŸ‡Έ

Palm Harbor, Florida, United States

Northwest Medical Specialists

πŸ‡ΊπŸ‡Έ

Arlington Heights, Illinois, United States

Jayne Gurtler, M.D., APMC

πŸ‡ΊπŸ‡Έ

Metairie, Louisiana, United States

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Brookwood Medical Center
πŸ‡ΊπŸ‡ΈBirmingham, Alabama, United States

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