Phase II Trial of Neoadjuvant Docetaxel and ZD 1839 (Iressa) Followed by Radical Prostatectomy in Patients With High Risk, Locally Advanced Prostate Cancer
It is recognized that there is a subset of patients who are at high risk for progression
despite aggressive treatment of localized disease at the time of detection. The critical
issue is in addressing micrometastatic disease that has already developed prior to
diagnosis. This study utilizes daily doses of ZD1839 and weekly docetaxel for two cycles
prior to radical prostatectomy.
ZD1839 has demonstrated antiproliferative activity against human tumor xenografts and in
coadministration with cytotoxic agents against prostate cell lines (PC-3 and TSU-PRI). The
combination of ZD1839 and docetaxel has been reported to be feasible with an acceptable
This phase II, single center trial is specifically targeting those patients with high-risk
adenosarcoma of the prostate.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the combination of docetaxel and ZD1839 on pathologic complete response (pCR) in radical prostatectomy specimens. Pathological complete response is defined as no microscopic evidence of neoplastic cells in the resected specimen.
Jacqueline Vuky, MD
Virginia Mason Medical Center
United States: Food and Drug Administration
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