Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
1 other identifier
interventional
84
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2004
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedResults Posted
Study results publicly available
November 22, 2019
CompletedDecember 17, 2019
December 1, 2019
4 years
August 29, 2005
October 8, 2019
December 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.
In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Secondary Outcomes (3)
Overall Response Rate (ORR) by EGFR Mutation Status
In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Overall Survival (OS)
In this study cohort, participants were followed for survival up to 155 months.
Overall Survival by EGFR Mutation Status
In this study cohort, participants were followed for survival up to 155 months.
Study Arms (1)
Erlotinib
EXPERIMENTALErlotinib: 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pasi A. Janne, MD, PhDlead
- Dana-Farber Cancer Institutecollaborator
- Massachusetts General Hospitalcollaborator
- Brigham and Women's Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Genentech, Inc.collaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (4)
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.
PMID: 16014882BACKGROUNDPerez-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.
PMID: 15310767BACKGROUNDJanne 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.
PMID: 15886310BACKGROUNDPaez 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.
PMID: 15118125BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Jackman, MD
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Pasi A Janne, MD, PhD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Medicine
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 30, 2005
Study Start
November 1, 2004
Primary Completion
November 1, 2008
Study Completion
July 1, 2019
Last Updated
December 17, 2019
Results First Posted
November 22, 2019
Record last verified: 2019-12