A Phase II Study of Sorafenib (BAY 43-9006) in Chemorefractory Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
BAY 43-9006® (Sorafenib) is an experimental agent designed to stop the growth of cancer
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 treatment studies.
The results of your tumor analysis helped the study doctor determine to assign you to this
particular treatment study.
While on study, you will take 2 tablets of sorafenib each morning, and again each evening.
Sorafenib should be taken with about 1 cup of water on an empty stomach (either 1 hour
before a meal or 2 hours after a meal). Sorafenib must be swallowed whole without chewing.
If you feel nauseated before or after taking the medication, anti-nausea medications should
be used. If you miss a dose, you should skip it and take the next scheduled dose at the
right time. Your medication should be stored at room temperature.
Every 4 weeks (1 cycle) your complete 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. Blood (about 2 teaspoons) and urine will be drawn for routine
tests. You will have a performance status evaluation (questions about your ability to
perform everyday activities) and blood drawn (about 1-2 teaspoons) to check your blood
clotting function. Your study doctor will also ask you about any medications you are taking
and your smoking history. You will be asked to record your weekly blood pressure for the
first 6 weeks of study treatment. The study doctor or research nurse will review the log at
each clinic visit.
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 6 weeks of treatment and then every cycle after
You may continue receiving sorafenib 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
or your medical condition gets worse. If you stop study treatment, you will be allowed to
enroll in one 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.
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. Sorafenib (BAY 43-9006) has been approved by the FDA for
treatment of advanced renal cell cancer; however, it's use in this research study is
investigational. Up to 62 patients will take part in this multicenter study. Up to 50 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
The number of participants with progression-free at week 8 out of total participants. Tumor measurements and assessment at baseline, at end of 2nd cycle (8 weeks), and then every 8 weeks (every other cycle) until treatment discontinuation.
George Blumenschein, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|