NCT02134886

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV Infection
• Recurrent Non-Small Cell Lung Carcinoma
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib Hydrochloride	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-05-09
• Last updated: 2015-10-06

Locations

5 sites across 1 country: United States