Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute; Pasi A. Janne, MD, PhD
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute; Genentech, Inc.; Massachusetts General Hospital
• Treatments: Erlotinib Hydrochloride

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 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:

• 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