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

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00602433
First received: January 17, 2008
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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
Advanced Nonsmall Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Hormonal Changes in Women on Erlotinib Therapy

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602433

Locations
United States, Illinois
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jyoti D. Patel, MD Northwestern University
  More Information

Additional Information:
No publications provided

Responsible Party: Jyoti Patel, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00602433     History of Changes
Other Study ID Numbers: NU 07CC4, STU00001887
Study First Received: January 17, 2008
Last Updated: April 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
advanced nonsmall cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014