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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050973
Recruitment Status : Completed
First Posted : January 3, 2003
Last Update Posted : May 14, 2013
Sponsor:
Information provided by:
Eisai Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: bexarotene Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : November 2004
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Bexarotene

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050973


Locations
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Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Mack Mabry, M.D. Ligand Pharmaceuticals
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00050973    
Obsolete Identifiers: NCT00030927
Other Study ID Numbers: L1069-49
First Posted: January 3, 2003    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: July 2008
Keywords provided by Eisai Inc.:
NSCLC
Targretin
Retinoid
Bexarotene
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bexarotene
Antineoplastic Agents