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

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00602433

Purpose

RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels.

PURPOSE: This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.

Condition	Intervention
Cancer-Related Problem/Condition Lung Cancer	Drug: erlotinib hydrochloride Procedure: laboratory biomarker analysis Procedure: questionnaire administration

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Evaluation of Hormonal Changes in Women on Erlotinib Therapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Presence of hyperandrogenemia [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dermatologic manifestations [ Designated as safety issue: No ]
Changes in body habitus and patterns of hair loss [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	December 2007
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine if hyperandrogenemia is present in women with non-small cell lung cancer who are receiving erlotinib hydrochloride.

Secondary

Describe the dermatologic manifestations in patients treated with this drug.
Describe changes in body habitus and patterns of hair loss in patients treated with this drug.

OUTLINE: 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

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

See Disease Characteristics

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

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

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jyoti D. Patel

Robert H. Lurie Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000581025, NU-07CC4
Study First Received:	January 17, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00602433
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

hormonal changes
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009