Status:
COMPLETED
Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
Lead Sponsor:
Pasi A. Janne, MD, PhD
Collaborating Sponsors:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Conditions:
Adenocarcinoma
Non-small Cell Lung Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00137839
Start Date
November 1 2004
End Date
July 1 2019
Last Update
December 17 2019
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115