Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Adenocarcinoma; Non-small Cell Lung Cancer	Drug: Erlotinib	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	75 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	October 2004
Estimated Primary Completion Date :	December 2016
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Intervention Details:

Drug: Erlotinib
Given orally once a day until disease progression or serious side effects occur.
Other Names:
• Tarceva
• OSI-774

Outcome Measures

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Primary Outcome Measures :

1. To determine how well non-small cell lung cancer cells in the body respond to Tarceva [ Time Frame: 4 years ]

Secondary Outcome Measures :

1. To determine the safety of Tarceva and what effects it has on women with adenocarcinoma of the lung [ Time Frame: 4 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	August 30, 2005
Last Update Posted:	August 3, 2016
Last Verified:	July 2016

Keywords provided by Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute:

Tarceva; Erlotinib; OSI-774; Adenocarcinoma; Advanced Lung Cancer

Additional relevant MeSH terms:

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