A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
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.
Every 28 days (one cycle) while the patient is taking Tarceva, they will be examined in the
outpatient clinic (blood test and physical examination) and the doctor will determine if
they should continue taking Tarceva.
After every two cycles of treatment (every 8 weeks) standard radiological testing (CT scans,
MRIs, and/or x-rays) of the cancer site(s) will be done to assess the response to the
While the patient is on this study and at the end of the study, the patient will undergo
blood and urine tests, medical history evaluation, physical exams including measures of
vital signs (blood pressure, heart rate, temperature, and respiration), bone scans, tumor
biopsy sample, and various radiological tests to monitor the cancer and the patients health.
The length of time on the study depends upon how the cancer responds to Tarceva and whether
or not the patient experiences unacceptable side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine how well non-small cell lung cancer cells in the body respond to Tarceva
Pasi A Janne, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|