Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00602433
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : April 15, 2011
Information provided by:
Northwestern University

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.

Condition or disease
Advanced Nonsmall Cell Lung Cancer

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Hormonal Changes in Women on Erlotinib Therapy
Study Start Date : December 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   Samples Without DNA
blood will be tested for different sex hormones as well as glucose metabolism

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects have advanced nonsmall cell lung cancer and have been taking erlotinib as part of anticancer therapy for at least 3 months.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00602433

Layout table for location information
United States, Illinois
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Layout table for investigator information
Principal Investigator: Jyoti D. Patel, MD Northwestern University

Layout table for additonal information
Responsible Party: Jyoti Patel, MD, Northwestern University Identifier: NCT00602433     History of Changes
Other Study ID Numbers: NU 07CC4
STU00001887 ( Other Identifier: Northwestern University IRB )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by Northwestern University:
advanced nonsmall cell lung cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action