A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Erlotinib hydrochloride is designed to help block the activity of an enzyme that is believed
to play an important role in cell growth. Researchers want to find out if blocking these
enzymes will slow tumor growth. Bexarotene is designed to control cancer cell growth and
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 and bexarotene by mouth once a day.
Erlotinib hydrochloride 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 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.
Bexarotene capsules should be taken with or immediately after a meal. If you miss a dose,
take it as soon as possible, with food. However, if it is nearly time for your next dose,
skip the missed dose and continue your dose schedule as before.
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 medication,
anti-nausea medications should be used.
The erlotinib hydrochloride tablets and bexarotene capsules should be stored at room
temperature. Bexarotene capsules should not be stored near heating devices, high
temperatures or humidity, or where children or pets have access to them. Bexarotene
capsules should be protected from sunlight.
Every 4 weeks (1 cycle) your medical history will be recorded and you will have a physical
exam, including measurement of vital signs (blood pressure, pulse, temperature, and
breathing rate) and weight. You will have routine blood tests (about 2 teaspoons) and a
performance status evaluation (questions about your ability to perform everyday activities).
You will have blood drawn (about 1-2 teaspoons) to check you thyroid function. You will
also have blood drawn (about 1-2 teaspoons) to check your lipid profile weekly for the first
4 weeks and then every cycle after that. Your study doctor will also ask you about any
medications you are taking and your smoking history.
Every 2 cycles, your 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 Coumadin® (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
You may continue receiving erlotinib hydrochloride and bexarotene 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.
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.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for
treatment of NSCLC in patients who have relapsed. Bexarotene is approved by the FDA for the
treatment of cutaneous T-cell lymphoma (CTCL). Their use together in this study is
investigational. Up to 72 patients will take part in this multicenter study. All will be
enrolled at M. D. Anderson.
Allocation: Randomized, 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)
Reimaging and re-biopsy (optional) of the tumor performed to assess the effects of the drugs on tumor markers after completing 2 cycles of therapy.
William N. William Jr., MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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