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Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is Metastatic or Cannot be Removed by Surgery in Patients With HIV Infection

HIV Infection Clinical Trial

Official title:
A Phase I/Pharmacokinetic Study of Erlotinib for Advanced Non-small Cell Lung Cancer in Persons With HIV Infection

Clinical Trial Summary

This phase I trial studies the side effects and best dose of erlotinib hydrochloride in treating non-small cell lung cancer that has spread to other parts of the body or cannot be removed by surgery in patients with human immunodeficiency virus (HIV) infection. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib hydrochloride is a standard drug used for treating lung cancer, however, it is not yet known whether it is safe to give erlotinib hydrochloride to patients who also have HIV infection or not.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of erlotinib (erlotinib hydrochloride) as a single agent in non-small cell lung cancer participants with HIV infection and to determine the maximum tolerated dose of erlotinib in combination with antiretroviral therapy in this participant population.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of erlotinib in advanced non-small cell lung cancer persons with HIV infection.

II. To investigate possible pharmacokinetic interactions between erlotinib and antiretroviral therapy in persons with HIV infection, while accounting for nicotine exposure.

III. To investigate the effects of therapy on participant immune status and HIV viral load.

IV. To preliminarily evaluate known molecular and phenotypic correlates of improved clinical outcomes associated with epidermal growth factor receptor (EGFR) inhibitors.

OUTLINE: This is a dose-escalation study.

Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02134886
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Terminated
Phase Phase 1
Start date July 2014
Completion date September 2015
View Details
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