Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer

NCT ID: NCT00125359

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2014-03-31

Brief Summary

The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.

Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Detailed Description

This is a single institution open label phase II trial. Consecutive, eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study. All eligible patients will receive continuous daily oral erlotinib 150 mg (Tarceva™) with daily bexarotene oral capsules 400 mg/m2 (Targretin®). The two agents will be taken at the same time. We anticipate the maximum accrual of 40 patients to this trial.

Patients will be evaluated by history, physical examination, and laboratory assessment every 4 weeks. Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated. Whole body PET scan will be obtained at 10 days and 8 weeks. All radiographic studies will be sent to Medical Metrix Solutions (MMS) for an independent radiographic review of tumor response.

Conditions

Carcinoma, Non-small-cell Lung

Study Design

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

Study Groups

1

All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg.

Group Type: EXPERIMENTAL

erlotinib and bexarotene

Intervention Type: DRUG

Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.

Interventions

erlotinib and bexarotene

Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Advanced NSCLC
• Prior chemotherapy or radiotherapy is allowed.

Exclusion Criteria

• Hepatic or renal dysfunction

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

Sponsors

Ligand Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Konstantin Dragnev

OTHER

Sponsor Role: lead

Responsible Party

Konstantin Dragnev

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Konstantin H Dragnev, MD

Role: PRINCIPAL_INVESTIGATOR

Norris Cotton Cancer Center

Locations

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

D-0440

Identifier Type: -

Identifier Source: org_study_id