A Phase I/II Dose-Escalation and Safety Study of ZD6474 (ZACTIMA) Used In Combination With Radiation Therapy for Patients With Inoperable/Unresectable Non-Small Cell Lung Cancer
ZD6474 is a new drug that is thought to block the formation of new blood vessels. The growth
of new blood vessels is called angiogenesis. Angiogenesis is thought to be essential for
the growth of tumors beyond a small size.
Before treatment starts, you will have several tests and procedures performed. These tests
will include a complete medical history and physical exam, including recent weight loss,
vital signs, and a test to check how easily you swallow. Laboratory tests needed will
require a urine sample, and blood samples (about 3-4 teaspoons). Women who are able to have
children must have a negative blood pregnancy test in order to participate in this study.
You will have an electrocardiogram (ECG--a test to measure the electrical activity of the
heart), heart function tests, and scans of your brain, chest, and bones. You will also have
PET scans performed.
You may take part in this study if you are a patient with NSCLC who is not able to receive
If you are eligible to participate, you will receive ZD6474 by mouth once a day every day,
along with radiation therapy. You must take your medication on an empty stomach, at
approximately the same time each morning. ZD6474 should be swallowed as a whole tablet (not
chewed, crushed or divided) and taken with 8 oz of water. Missed doses may be taken by the
end of the same calendar day. However, if a subject misses taking their scheduled dose on
the same day, he or she must take the next scheduled dose and the missed dose will not be
made up. The missed dose must be documented on patients medication diary ZD6474 will be
given 5-7 days before starting radiation therapy and will continue through the entire course
of radiation therapy, unless there is proof that the cancer is progressing. ZD6474 may
interact with many commonly prescribed medications. A list will be provided to you.
Radiation will be given every weekday (Monday - Friday) for 3-7 weeks as your doctor thinks
is necessary and useful. You will have weekly evaluations during radiation treatment,
including blood samples (3-4 teaspoons) for routine testing, oxygen saturation (a test that
measures how much oxygen is in the blood), and physical examination.
If you need anti-nausea medication (such as Zofran) during this study, you will have an ECG
performed within 24 hours of starting the medication and then again at least once a week
while you remain on the medication.
You will continue on study, unless there is evidence that the disease has gotten worse or
intolerable side effects occur.
You will be seen for a follow-up visit one month after completing radiation therapy, and
again at 3 months. You will then come in for a follow-up visit every 3 months for 2 years,
then every 6 months for 3 years, then once a year. Scheduled tests and follow-ups should
be performed within 1 week (before or after) of the scheduled time period (a 14-day window).
At these visits, you will have blood draws (about 3-4 teaspoons), urine tests and x-rays.
You will have an ECG, lung function tests, and PET/CT scans.
Participants who are blood donors should not donate blood during the study and for 3 months
following their last dose of study treatment.
This is an investigational study. ZD6474 is not FDA approved, and has been authorized for
research only. A total of up to 48 patients will take part in this study. All patients
will be enrolled at UTMDACC.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Weekly evaulations from baseline through 3 to 7 weeks of treatment (3-5 days per week for radiation and up to 3 doses tested)
Melenda D. Jeter, MD, MPH
Assistant Professor, UT MDACC
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|