Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
NCT ID: NCT00137839
Last Updated: 2019-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2004-11-30
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Erlotinib
Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
Erlotinib
Interventions
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Erlotinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 four (IV) or three (III) B 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
* 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
18 Years
FEMALE
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Massachusetts General Hospital
OTHER
Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Genentech, Inc.
INDUSTRY
Pasi A. Janne, MD, PhD
OTHER
Responsible Party
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Pasi A. Janne, MD, PhD
Associate Professor, Medicine
Principal Investigators
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Pasi A Janne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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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, Santabarbara 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. doi: 10.1056/NEJMoa050753.
Perez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara 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. doi: 10.1200/JCO.2004.11.057.
Janne 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. doi: 10.1200/JCO.2005.09.985.
Paez JG, Janne 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. doi: 10.1126/science.1099314. Epub 2004 Apr 29.
Related Links
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Dana-Farber Cancer Institute Lowe Thoracic Oncology Program
Other Identifiers
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04-253
Identifier Type: -
Identifier Source: org_study_id