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

Evaluation of Hormonal Changes in Women on Erlotinib Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00602433

Enrollment

Registered

2008-01-28

Start date

2007-12-31

Completion date

2009-08-31

Last updated

2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Nonsmall Cell Lung Cancer

Keywords

advanced nonsmall cell lung cancer

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Presence of hyperandrogenemia	One approximate 30 minute visit	We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib.

Secondary

Measure	Time frame	Description
Dermatologic manifestations	One approximate 30 minute visit	We will describe the dermatologic manifestations of erlotinib in women
Changes in body habitus and patterns of hair loss	One approximate 30 minute visit	We will describe changes in body habitus and patterns of hair loss from women on erlotinib.

Countries

United States

Outcome results