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

Advanced Nonsmall Cell Lung Cancer Clinical Trial

Official title:

Evaluation of Hormonal Changes in Women on Erlotinib Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602433
• Other study ID #: NU 07CC4
• Secondary ID: STU00001887
• Status: Completed
• Phase: N/A
• First received: January 17, 2008
• Last updated: April 14, 2011
• Start date: December 2007
• Est. completion date: August 2009

Study information

• Verified date: April 2011
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Nonsmall Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Locations

Country	Name	City	State
United States	Northwestern University, Northwestern Medical Faculty Foundation	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of hyperandrogenemia	We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib.	One approximate 30 minute visit	No
Secondary	Dermatologic manifestations	We will describe the dermatologic manifestations of erlotinib in women	One approximate 30 minute visit	No
Secondary	Changes in body habitus and patterns of hair loss	We will describe changes in body habitus and patterns of hair loss from women on erlotinib.	One approximate 30 minute visit	No