A Phase II, Open Label Study of Erlotinib (Tarceva) in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer
Erlotinib hydrochloride is designed to block the activity of an enzyme found on the surface
of many tumor cells that may slow tumor growth.
In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A
Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung
Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE
program. Participants in Protocol 2005-0823 are assigned to one of the research studies.
The results of your tumor analysis helped the study doctor determine to assign you to this
particular research study.
While on study, you will take erlotinib hydrochloride by mouth once a day. Tablets should
be taken preferably in the morning 1 hour before or 2 hours after a meal with no more than 7
ounces of water. If you are unable to swallow tablets, you may dissolve the tablets in
distilled water. If you forget to take a dose, the last missed dose should be taken as soon
as you remember, as long as it is at least 12 hours before the next dose is due to be taken.
The next day, you should take the scheduled dose at the usual time. Every attempt should
be made to keep from vomiting the medication for at least 30 minutes after taking it. For
example, if you feel nauseated before or after taking the erlotinib, anti-nausea medications
should be used. The dose of erlotinib hydrochloride may be repeated if vomiting occurs
within 30 minutes of taking the tablet. Four (4) weeks is considered 1 treatment cycle.
Every 4 weeks, your complete medical history will be recorded and you will have a physical
exam, including measurement of vital signs (blood pressure, pulse, temperature, breathing
rate) and weight. You will have blood drawn (about 2 teaspoons) for routine tests. You
will have a performance status evaluation (questions about your ability to perform everyday
activities). Your study doctor will ask you about any medications you are taking and your
smoking history. Every 2 cycles, the tumor will be evaluated by chest x-ray and computed
tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the
disease. If you are taking warfarin, you will have blood drawn (about 1-2 teaspoons) to
check your blood clotting function weekly for the first 5 weeks of treatment and then every
cycle after that.
You may continue receiving erlotinib hydrochloride for as long as the cancer responds to
study treatment. Your doctor may decide to take you off this study if you experience
intolerable side effects, your medical condition gets worse, or you are unable to comply
with study requirements. If you stop study treatment, you may be able to enroll in 1 of the
remaining 3 protocols of the BATTLE program. You should discuss this with your doctor.
After you have stopped taking the study treatment, you will have a physical exam, including
measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for
routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood
clotting function. You will have a performance status evaluation, a chest x-ray, and a CT
or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months
for up to 3 years, to see how you are doing.
You have the right to leave the study at any time. If you choose to stop participating in
this study, you should contact the study chair and/or research nurse. Your doctor may
decide to take you off this study if your medical condition gets worse and/or you are unable
to comply with study requirements.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for
treatment of NSCLC in patients who have relapsed. Up to 72 patients will take part in this
study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
8 Week Progression-Free Survival Rate (i.e. disease control rate)
Radiographic evaluation after cycle 2 (8 weeks of therapy)
Pierre Saintigny, MD, PHD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|