Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib

Northwestern University

Status: Completed

Conditions: Advanced Nonsmall Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00602433

STU00001887 (Other Identifier)

NU 07CC4

Details and patient eligibility

About

Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels.

This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.

Full description

Patients undergo a dermatology evaluation and complete the Polycystic Ovarian Syndrome (PCOS) research study questionnaire once. Blood samples are collected after an overnight fast. Samples are analyzed for circulating levels of total and bioavailable testosterone, dehydroepiandrosterone sulfate, and sex hormone binding globulin. Serum luteinizing hormone, follicle stimulating hormone, fasting glucose, and insulin levels are also assessed.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Histologically confirmed non-small cell lung cancer

  • Stage IIIB (effusion) or stage IV disease

• Must be receiving daily erlotinib hydrochloride for more than 3 months

• Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess

Trial design

10 participants in 1 patient group

questionnaire and laboratory biomarker analysis

Description:

Subjects with advanced non-small cell lung cancer and take erlotinib as part of their anticancer therapy for at least 3 months. Subjects have had some changes in hair growth, acne or menses (periods) that might be a side effect of erlotinib. Subjects will complete a questionnaire and blood collected for biomarker analysis.