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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02134886
Phase
PHASE1
Status
Terminated

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

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.

Key Dates

First listed
May 9, 2014
Start date
Jul 31, 2014
Status verified
Jun 2015
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (erlotinib hydrochloride)
    Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of toxicities evaluated with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) [ Time Frame: Up to 30 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA Center for Clinical AIDS Research and EducationLos AngelesCalifornia90035-
University of California San DiegoSan DiegoCalifornia92103-
Albert Einstein College of MedicineThe BronxNew York10461-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-2490-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-

Find similar trials in Los Angeles, CA

By condition
HIV
By specialty
Infectious disease
By research site
UCLA Center for Clinical AIDS Research and Education· Los Angeles, CAUniversity of California San Diego· San Diego, CAAlbert Einstein College of Medicine· The Bronx, NYMontefiore Medical Center - Moses Campus· The Bronx, NYMontefiore Medical Center-Einstein Campus· The Bronx, NY

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