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

Carcinoma, Non-small-cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00153842
• Other study ID #: D-0109
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 2001
• Est. completion date: March 2009

Study information

• Verified date: February 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-small-cell Lung

Intervention

Drug:
• Bexarotene (targretin)
Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). Level 1: 300 mg
• Bexarotene (targretin)
Bexarotene oral capsules will be administered daily beginning on the intitial day of chemotherapy (Day 1). Level 2: 400 mg

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Bristol-Myers Squibb, Ligand Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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