A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Carcinoma, Non-small-cell Lung

Intervention / Treatment
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* Drug: Bexarotene (targretin)
* Drug: Bexarotene (targretin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bexarotene<br>Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). | Drug: Bexarotene (targretin)<br>* Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). Level 1: 300 mg<br>* Other names: Targretin, LGD1069;Drug: Bexarotene (targretin)<br>* Bexarotene oral capsules will be administered daily beginning on the intitial day of chemotherapy (Day 1). Level 2: 400 mg<br>* Other names: Targretin, LGD1069;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bexarotene Oral Capsules Safety 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. For the purpose of this protocol, an initial-dose-limiting toxicity (IDLT) is defined as a clinical observation that is, in the judgment of the Investigator, both attributable to the administration of bexarotene and necessitates a reduction in dose, suspension or discontinuation of study drug because of a NCI CTC Grade 3 or 4 level toxicity (with the exception of elevated lipids). | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Bexarotene, Targretin