GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
Prostate cancer is one of the most common malignancies affecting men all over the World.
Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25
months). Prostate cancer that grows despite castrate levels of testosterone and that no
longer responds to any form of hormonal manipulation is defined as castrate resistant
prostate cancer (CRPC).
Docetaxel combined with prednisolone has been shown to not only improve QOL and PSA response
in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not
been universally effective, and nearly all patients have disease progression after docetaxel
treatment.
After failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone, which
are not widely and easily availabe in Korea, little treatment regimen can be applied to the
patients with reasonable response and benefits.
Gemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors.
When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with
median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in
pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of
57% in patients with measurable disease.
Oxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of
activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II
study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either
alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including
cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients in
each arm.
Gemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe
and effective in various cancers.
This study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.