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

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Trial phase: 
Phase I
Recruitment status: 
Terminated

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.

Background information
Trial ID: 
NCT00153842
Other unique IDs: 
D-0109
Official title: 

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

Detailed description: 

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.

Number to be enrolled: 
59 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility 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

Study design: 
Treatment
Single Group Assignment
Safety/Efficacy Study
Open Label
Non-Randomized
Uncontrolled
Interventions: 
Bexarotene (targretin)
Conditions treated: 
Carcinoma, Non-Small-Cell Lung
Funding
Funding types: 
OTHER
INDUSTRY
Sponsor: 
Bristol-Myers Squibb
Dartmouth-Hitchcock Medical Center
Ligand Pharmaceuticals
Dates
Date the data was first received: 
Thu, 2005-09-08
Trial start date: 
Wed, 2001-08-01
Trial completion date: 
Sun, 2009-03-01
Trial last updated: 
Wed, 2009-05-20