AZD2171 to Treat Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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. ...

Key facts

Study ID

NCT00436956

Run by

National Cancer Institute (NCI)

People needed

59

Starts

2006-10-16

Expected to finish

2014-02-05

Last updated by the study team

2018-10-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
• Patients may not be receiving any agents not approved by the Food and Drug Administration (FDA) within the past four weeks.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Mean QTc greater than 470 msec (with Bazett's correction) in screening electrocardiogram or history of familial long Q wave, T wave (QT) syndrome.
• Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart.
• Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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