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

Dartmouth Health

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Carcinoma, Non-small-cell Lung

Treatments: Drug: Bexarotene (targretin)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00153842

D-0109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

Bexarotene

Experimental group

Description:

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

Treatment:

Drug: Bexarotene (targretin)

Drug: Bexarotene (targretin)