Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Massachusetts General Hospital

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Genentech, Inc.

Information provided by (Responsible Party):

Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00137839

First received: August 29, 2005

Last updated: August 2, 2016

Last verified: July 2016

History of Changes

Purpose

The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.

Condition	Intervention	Phase
Adenocarcinoma Non-small Cell Lung Cancer	Drug: Erlotinib	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

Genetic and Rare Diseases Information Center resources: Lung Adenocarcinoma

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine how well non-small cell lung cancer cells in the body respond to Tarceva [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety of Tarceva and what effects it has on women with adenocarcinoma of the lung [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	75
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Intervention Details:

Given orally once a day until disease progression or serious side effects occur.

Other Names:

Tarceva
OSI-774

Detailed Description:

Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.

Every 28 days (one cycle) while the patient is taking Tarceva, they will be examined in the outpatient clinic (blood test and physical examination) and the doctor will determine if they should continue taking Tarceva.

After every two cycles of treatment (every 8 weeks) standard radiological testing (CT scans, MRIs, and/or x-rays) of the cancer site(s) will be done to assess the response to the Tarceva treatment.

While the patient is on this study and at the end of the study, the patient will undergo blood and urine tests, medical history evaluation, physical exams including measures of vital signs (blood pressure, heart rate, temperature, and respiration), bone scans, tumor biopsy sample, and various radiological tests to monitor the cancer and the patients health.

The length of time on the study depends upon how the cancer responds to Tarceva and whether or not the patient experiences unacceptable side effects.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female
Diagnosis of adenocarcinoma of the lung
Patient has had at least one core biopsy of her tumor
Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
Stage IV or IIIB non-small cell lung cancer
Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
Three or more weeks since last radiation therapy
Three or more weeks since last major surgery
Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
Life expectancy of 8 weeks or more
Blood tests that show kidneys, liver and bone marrow to be working adequately
Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study

Exclusion Criteria:

Prior exposure to Tarceva (OSI-774, erlotinib)
Uncontrolled central nervous system problems
Prior chemotherapy regimen
Difficulty swallowing
A disease or disorder that interferes with ability to digest and absorb food
Incomplete healing of previous oncologic or other major surgery
Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
Pregnant or breast feeding
A medical condition that could make it unsafe for patient to participate in this study

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: NCT00137839

Locations


United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Genentech, Inc.

Investigators


Principal Investigator:	Pasi A Janne, MD, PhD	Dana-Farber Cancer Institute

More Information

Additional Information:

Dana-Farber Cancer Institute Lowe Thoracic Oncology Program This link exits the ClinicalTrials.gov site

Publications:

Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabárbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32.

Pérez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabárbara P, Bonomi P. Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer. J Clin Oncol. 2004 Aug 15;22(16):3238-47.

Jänne PA, Engelman JA, Johnson BE. Epidermal growth factor receptor mutations in non-small-cell lung cancer: implications for treatment and tumor biology. J Clin Oncol. 2005 May 10;23(14):3227-34. Review.

Paez JG, Jänne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004 Jun 4;304(5676):1497-500. Epub 2004 Apr 29.


Responsible Party:	Pasi A. Janne, MD, PhD, Associate Professor, Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00137839 History of Changes
Other Study ID Numbers:	04-253
Study First Received:	August 29, 2005
Last Updated:	August 2, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:


Tarceva Erlotinib OSI-774 Adenocarcinoma Advanced Lung Cancer

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Adenocarcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic	Bronchial Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016

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