Trial Information

Phase I and II Clinical Studies of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules for the Treatment of Patients With Advanced Non-Small Cell Lung Cancer

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.