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

NCT ID: NCT00153842

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2009-03-31

Brief Summary

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

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.

Conditions

Carcinoma, Non-small-cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bexarotene

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

Group Type: EXPERIMENTAL

Bexarotene (targretin)

Intervention Type: DRUG

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

Level 1: 300 mg

Bexarotene (targretin)

Intervention Type: DRUG

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

Level 2: 400 mg

Interventions

Bexarotene (targretin)

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

Level 1: 300 mg

Intervention Type: DRUG

Bexarotene (targretin)

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

Level 2: 400 mg

Intervention Type: DRUG

Other Intervention Names

Targretin, LGD1069; Targretin, LGD1069

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Ligand Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R Rigas, MD

Role: PRINCIPAL_INVESTIGATOR

Norris Cotton Cancer Center

Locations

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D-0109

Identifier Type: -

Identifier Source: org_study_id