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AZD2171 to Treat Prostate Cancer

NCT00436956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-10-09

Study results available
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Summary

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.

...

Conditions

Interventions

PROCEDURE

Magnetic Resonance Imaging (DCE-MRI)

Scans evaluate tumor tissue and blood flow.

DRUG

AZD2171

20 mg oral daily for 28 days

DRUG

Prednisone

10mg orally daily in combination with AZD2171 20mg daily.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William L Dahut, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-16
Primary Completion
2010-02-01
Completion
2014-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00436956 on ClinicalTrials.gov