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OpenTrials
Completed

NCT Number: NCT00602433

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

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.

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Key information

Conditions

Advanced Nonsmall Cell Lung Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611-3013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Presence of hyperandrogenemia

    Time frame: One approximate 30 minute visit

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

Secondary outcomes

  1. Dermatologic manifestations

    Time frame: One approximate 30 minute visit

    We will describe the dermatologic manifestations of erlotinib in women

  2. Changes in body habitus and patterns of hair loss

    Time frame: One approximate 30 minute visit

    We will describe changes in body habitus and patterns of hair loss from women on erlotinib.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Evaluation of Hormonal Changes in Women on Erlotinib Therapy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 28, 2008
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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