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
• Interventions: Drug: bexarotene with carboplatin and paclitaxel; Drug: carboplatin and paclitaxel

• Registration Number: NCT00050960
• 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 Carboplatin and Paclitaxel 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 three 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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-12-31
• Study First Submitted QC: 2003-01-02
• Study First Posted: 2003-01-03
• Primary Completion: 2004-07
• Study Completion: 2005-03
• Results First Submitted: 2010-07-23
• Results First Submitted QC: 2010-07-23
• Results First Posted: 2010-08-24
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-07
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 612

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bexarotene with carboplatin and paclitaxel	bexarotene with carboplatin and paclitaxel	-
carboplatin and paclitaxel	carboplatin and paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	From date of randomization to date of death

Trial Locations

Locations (151)

Montgomery Cancer Center, L.L.C.; 🇺🇸 Montgomery, Alabama, United States

Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

Bay Area Cancer Research Group, LLC; 🇺🇸 Concord, California, United States

Compassionate Cancer Care Medical Group, Inc.; 🇺🇸 Fountain Valley, California, United States

Pacific Coast Hematology/Oncology Medical Group, Inc.; 🇺🇸 Fountain Valley, California, United States

California Cancer Care, Inc.; 🇺🇸 Greenbrae, California, United States

Coast Hematology and Oncology Associates; 🇺🇸 Long Beach, California, United States

Metropolitan Hematology/Oncology Medical Group; 🇺🇸 Los Angeles, California, United States

Sant P. Chawla, Inc.; 🇺🇸 Los Angeles, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

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