Background:
- AZD2171 (Cediranib) is an experimental drug that inhibits formation of new blood
vessels.
- Tumors need new blood vessels to grow. Preventing the growth of new blood vessels with
AZD2171 may inhibit tumor growth.
Objectives:
-To determine the effectiveness and side effects of AZD2171 in patients with prostate cancer
that has metastasized (spread beyond the primary site).
Eligibility:
- Males 18 years of age and older with androgen-independent prostate cancer that has
metastasized.
- Patients must have received prior treatment with docetaxel.
Design:
Patients take one AZD2171 by mouth every day in 28-day treatment cycles and undergo the
following procedures:
- 1- to 2-day hospitalization at the start of the study for biopsies and blood
measurements to determine the level of AZD2171 in the bloodstream. Blood is drawn
immediately before the first dose, and 0.25 hr, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12
hr, 24 hr, and 48 hours after the dose is taken.
- Blood tests before starting treatment and then monthly to determine the level of
vascular endothelial growth factor receptor ( VEGFR), a protein involved in blood vessel
formation.
- Magnetic resonance imaging (MRI) scans once a month to evaluate blood flow.
- Tumor biopsies (optional) both before and after the second and sixth treatment cycles.
- Clinic visits every 4 weeks, including various routine and research blood tests, urine
test and electrocardiogram.
- Computed tomography (CT) scan of the chest, abdomen, and pelvis every 8 weeks
- Bone scan every 8 weeks
Patients record all doses of AZD2171 taken or missed in a pill diary. They record their blood
pressure at least once daily in a blood pressure diary.
Treatment may continue as long as the patient tolerates the AZD2171 and the cancer does not
worsen.
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