Lung Cancer Clinical Trial

Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

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.

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Full 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.

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Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT00137839

Recruitment Status:

Completed

Sponsor:

Pasi A. Janne, MD, PhD

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There are 2 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT00137839

Recruitment Status:

Completed

Sponsor:


Pasi A. Janne, MD, PhD

How clear is this clinincal trial information?

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