Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Completed · Phase 2

Conditions studied: Adenocarcinoma, Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00137839

Run by

Pasi A. Janne, MD, PhD

People needed

84

Starts

2004-11-01

Expected to finish

2019-07-01

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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