Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is

Status Terminated

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

Acquired Immunodeficiency Syndrome
Carcinoma, Non-Small-Cell Lung
HIV Infection
HIV Infections
Infection
Lung Neoplasms
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

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

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms