A Randomized, Phase II Trial of AZD2171, Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients With Metastatic, Hormone Refractory Prostate Cancer
I. To determine the 6-month progression-free survival rate of patients with hormone
refractory metastatic adenocarcinoma of the prostate treated with docetaxel and prednisone
with vs without cediranib.
I. To evaluate the safety profile of cediranib, docetaxel, and prednisone in patients with
metastatic hormone-refractory prostate cancer.
II. To determine the duration of prostate-specific antigen (PSA) response and PSA control in
patients with metastatic hormone-refractory prostate cancer treated with cediranib,
docetaxel, and prednisone.
III. To determine the partial and complete response rate in patients with measurable disease
treated with cediranib, docetaxel, and prednisone.
IV. To determine time to progression in patients with metastatic hormone-refractory prostate
cancer treated with cediranib, docetaxel, and prednisone.
V. To determine overall survival in patients with metastatic hormone-refractory prostate
VI. To perform correlative marker studies measuring serum levels of VEGF, PDGF, sICAM, bFGF,
interleukin (IL)-6, and IL-8.
VII. To perform a pilot study of [F18]FMAU positron emission test (PET) imaging on patients
receiving cediranib, docetaxel, and prednisone.
OUTLINE: This is a multicenter study. Patients are stratified by participating institution.
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on
day 1, and oral prednisone twice daily on days 1-21.
ARM II: Patients receive docetaxel and prednisone as in arm I.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Archival paraffin-embedded tissue blocks or slides from time of
diagnosis (or subsequent, but prior to therapy) are evaluated for expression of molecular
targets relevant to this study. Blood specimens from baseline, after courses 1 and 2, and
after completion of study treatment are analyzed for protein markers. Samples are analyzed
by ELISA and IHC for angiogenesis-associated plasma proteins, plasma levels of VEGF, tumor
expression of PDGFR, and interleukin (IL)-6 and IL-8 plasma levels. Patients also undergo
positron emission test (PET) scans utilizing fluorodeoxyglucose (FDG) at baseline and after
After completion of study treatment, patients are followed every 3 months for 52 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate
The PFS distribution is subject to censoring, and will be analyzed with standard Kaplan-Meier (K-M) methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored PFS distribution.
Up to 6 months
Wayne State University
United States: Food and Drug Administration
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Wayne State University||Detroit, Michigan 48202|
|M D Anderson Cancer Center||Houston, Texas 77030|