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

NCT00153842 | Terminated Phase 1 Results DMC

• 1 other identifier: D-0109
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-small-cell Lung

Keywords

NSCLC; Bexarotene; Targretin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bexarotene

EXPERIMENTAL

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

Drug: Bexarotene (targretin)

Interventions

Bexarotene (targretin) DRUG

Bexarotene oral capsules will be administered daily beginning on the initial day of chemotherapy (day 1). Level 1: 300 mg

Also known as: Targretin, LGD1069

Bexarotene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unresectable stage IIIB or IV NSCLC
• adequate bone marrow, hepatic, thyroid and renal function

You may not qualify if:

• peripheral neuropathy \>= grade 2
• gastrointestinal abnormalities
• known hypersensitivity to retinoids

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Bristol-Myers Squibb: collaborator
• Ligand Pharmaceuticals: collaborator

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: James Rigas, MD
• Organization: Dartmouth-Hitchcock Medical Center

Cancer.Research.Nurse@Dartmouth.edu

603-650-6344

Study Officials

• James R Rigas, MD

  Norris Cotton Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2001
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 6, 2019
• Results First Posted: March 6, 2019

Record last verified: 2019-02

Locations

US (1)