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

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00050960

Purpose

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
Non-small Cell Lung Cancer	Drug: bexarotene with carboplatin and paclitaxel Drug: carboplatin and paclitaxel	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Bexarotene

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Overall Survival [ Time Frame: From date of randomization to date of death ] [ Designated as safety issue: No ]

Enrollment:	612
Study Start Date:	May 2002
Study Completion Date:	March 2005
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: bexarotene with carboplatin and paclitaxel	Drug: bexarotene with carboplatin and paclitaxel bexarotene capsules in combination with carboplatin IV and paclitaxel IV
Experimental: carboplatin and paclitaxel	Drug: carboplatin and paclitaxel carboplatin IV and paclitaxel IV

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050960

Show 154 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Mack Mabry, M.D.

Ligand Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eisai, Inc
ClinicalTrials.gov Identifier:	NCT00050960 History of Changes
Obsolete Identifiers:	NCT00036907
Other Study ID Numbers:	L1069-48
Study First Received:	December 31, 2002
Results First Received:	July 23, 2010
Last Updated:	July 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

NSCLC
Targretin
Retinoid
Bexarotene

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bexarotene
Carboplatin

Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012