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

This study has been terminated.
(study closed to enrollment 04/07/2005 due to two large phase III trials showing no survival benefit of combining bexarotene with platinum-based chemotherapy)
Sponsor:
Collaborators:
Bristol-Myers Squibb
Ligand Pharmaceuticals
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00153842
First received: September 8, 2005
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • To evaluate the safety of administering bexarotene oral capsules (Targretin) daily at two dose levels in combination with carboplatin (Paraplatin) and two schedules of Taxol in advanced non-small cell lung cancer. [ Time Frame: Begining of enrollment to accrual of patients and data analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the preliminary efficacy of bexarotene oral capsules (Targretin) in combination with carboplatin (Paraplatin) and weekly Taxol given every 4 weeks in advanced non-small cell lung cancer (Phase II component). [ Time Frame: Enrollment of first subject to accural of subjects/ data analysis. ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2001
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).
Drug: Bexarotene (targretin)

Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1).

Level 1: 300mg Level 2: 400mg

Other Name: Targretin, LGD1069

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153842

Locations
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Bristol-Myers Squibb
Ligand Pharmaceuticals
Investigators
Principal Investigator: James R Rigas, MD Norris Cotton Cancer Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00153842     History of Changes
Other Study ID Numbers: D-0109
Study First Received: September 8, 2005
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
NSCLC
Bexarotene
Targretin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bexarotene
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014