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.
Advanced Nonsmall Cell Lung Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation of Hormonal Changes in Women on Erlotinib Therapy|
- Presence of hyperandrogenemia [ Time Frame: One approximate 30 minute visit ] [ Designated as safety issue: No ]We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib.
- Dermatologic manifestations [ Time Frame: One approximate 30 minute visit ] [ Designated as safety issue: No ]We will describe the dermatologic manifestations of erlotinib in women
- Changes in body habitus and patterns of hair loss [ Time Frame: One approximate 30 minute visit ] [ Designated as safety issue: No ]We will describe changes in body habitus and patterns of hair loss from women on erlotinib.
Biospecimen Retention: Samples Without DNA
blood will be tested for different sex hormones as well as glucose metabolism
|Study Start Date:||December 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
questionnaire and laboratory biomarker analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602433
|United States, Illinois|
|Northwestern University, Northwestern Medical Faculty Foundation|
|Chicago, Illinois, United States, 60611-3013|
|Principal Investigator:||Jyoti D. Patel, MD||Northwestern University|