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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00050973
First received: December 31, 2002
Last updated: May 13, 2013
Last verified: July 2008

December 31, 2002
May 13, 2013
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November 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00050973 on ClinicalTrials.gov Archive Site
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Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
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

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 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
Drug: bexarotene
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
623
March 2005
November 2004   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
Greece,   United Kingdom,   Poland,   Russian Federation,   United States,   Israel,   Australia,   Canada,   France,   Hungary,   Czech Republic
 
NCT00050973
L1069-49
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Eisai Inc.
Not Provided
Study Director: Mack Mabry, M.D. Ligand Pharmaceuticals
Eisai Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP