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Evaluation of Hormonal Changes in Women on Erlotinib Therapy

18 Years
Not Enrolling
Advanced Nonsmall Cell Lung Cancer

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Trial Information

Evaluation of Hormonal Changes in Women on Erlotinib Therapy

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.

Inclusion 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Presence of hyperandrogenemia

Outcome Description:

We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib.

Outcome Time Frame:

One approximate 30 minute visit

Safety Issue:


Principal Investigator

Jyoti D. Patel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:

NU 07CC4



Start Date:

December 2007

Completion Date:

August 2009

Related Keywords:

  • Advanced Nonsmall Cell Lung Cancer
  • advanced nonsmall cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Northwestern University, Northwestern Medical Faculty FoundationChicago, Illinois  60611-3013