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

Eisai Inc.612 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

612

Conditions

Non-small Cell Lung Cancer

Interventions

bexarotene with carboplatin and paclitaxelDRUG

bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.

carboplatin and paclitaxelDRUG

carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Patients must have: * Pathologic (histologic or cytologic) confirmation of NSCLC * Stage IIIB with malignant pleural effusion or Stage IV disease * At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy * ECOG performance status 0 or 1 * Adequate organ system function * Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy). Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months) Patients must not have had: * Brain metastasis * Prior chemotherapy for NSCLC * Prior platinum-based chemotherapy for any indication

Locations (154)

Outcomes

Primary Outcomes

Overall Survival

Time frame: From date of randomization to date of death

Data from ClinicalTrials.gov

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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

...and 144 more locations