At a glance
ClinicalIndex Comparison Record- ✓Histopathological confirmation of prostate cancer
- ✓Metastatic progressive androgen-independent prostate cancer with radiographic evidence of progression despite hormonal therapy
- ✓Prior docetaxel therapy for androgen-independent prostate cancer (any number of prior treatments acceptable)
- ✓Age ≥18 years
- ✕Chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
- ✕Non-FDA-approved agents within past 4 weeks
- ✕Known brain metastases
- ✕Other invasive malignancies within past 3 years (except non-melanoma skin cancers or non-invasive bladder cancer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Magnetic Resonance Imaging (DCE-MRI), AZD2171, and 1 other intervention for Prostate Cancer. Completed, enrolled 59 participants across 1 site.
Detailed 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. ...
Study Details
Timeline
Interventions
Scans evaluate tumor tissue and blood flow.
20 mg oral daily for 28 days
10mg orally daily in combination with AZD2171 20mg daily.