A Phase II, Open Label Study of ZD6474 in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
ZD6474 is designed to block the formation of new blood vessels. The growth of new blood
vessels is called angiogenesis. Angiogenesis is thought to be important for the growth of
tumors beyond a small size. Researchers want to find out if ZD6474 will limit new blood
vessel growth in the tumor and "starve" the tumor by limiting blood flow to it.
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 treatment study.
While on study, you will take ZD6474 by mouth each morning. ZD6474 is swallowed as a whole
tablet. The tablet should not be chewed, crushed, or divided and should be taken with 8
ounces of water and a small amount of food to lessen stomach discomfort. You should take
ZD6474 at about the same time every day. Four (4) weeks is considered 1 treatment cycle.
If you miss a dose and are unable to take the missed dose on the same day, you should take
the next scheduled dose and the missed dose will not be made up. The dose of study
medication may be repeated if vomiting occurs within 30 minutes of taking the study
You will have routine blood tests (about 2 teaspoons) at Weeks 1, 2, 4, 8, 12, then every 4
weeks after that. You will have an electrocardiogram (ECG -- a test that measures the
electrical activity of the heart) at Weeks 1, 2, 4, 8, 12, then every 3 months after that.
Every 4 weeks, your complete medical history will be recorded and you will have a physical
exam, including measurement of vital signs (blood pressure, heart rate, temperature, and
breathing rate), a performance status evaluation, and weight. You will also have a routine
urine test and your study doctor will ask you about any medications you are taking and your
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, you will have blood drawn (about 1-2 teaspoons) to check your blood
clotting function every week. You will be asked to bring your unused medication to each
You may continue receiving ZD6474 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, and/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, chest x-ray, ECG, 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.
This is an investigational study. ZD6474 is an investigational drug that has been approved
by the FDA for research use only. Up to 72 patients will take part in this multicenter
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
The number of participants 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.
Baseline to 8 Weeks
Anne S. Tsao, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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