The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Bexarotene (targretin)	Phase I Phase II

Further Study Details: 

Primary Outcomes: Patients will be evaluated by history, physical examination, and laboratory assessment on day 1, 8, and 15 for the first 2 months and then every 4 weeks.
Secondary Outcomes: Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and chest computer tomograph every 8 weeks.
Expected Total Enrollment:  59

The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels (300 mg/m2 and 400 mg/m2) in combination with carboplatin and Taxol®. At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules (300 mg/m2 or 400 mg/m2) in combination with carboplatin and Taxol® that induces DLT in fewer than or equal to 33% of patients.

The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol® in patients with advanced non-small cell lung cancer. The efficacy will be gauged according to the rate of major response where, by definition, a major response occurs if a patient achieves either complete remission (CR) or partial remission (PR). For these patients a true response rate of 20% or greater is sufficiently large to warrant further investigation. A true response rate of 10% or less indicates that the combination is less active.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• unresectable stage IIIB or IV NSCLC
• adequate bone marrow, hepatic, thyroid and renal function

Exclusion Criteria:

• peripheral neuropathy >= grade 2
• gastrointestinal abnormalities
• known hypersensitivity to retinoids

New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States

Study chairs or principal investigators

James R Rigas, MD,  Principal Investigator,  Norris Cotton Cancer Center   

Study ID Numbers:  D-0109
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153842
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13