A Prosepctive Phase II Study of Gemcitabine and Oxaliplatin in Combination With Prednisolone for the Treatment of Hormone Refracotry Metastatic Prostate Cancer Previously Treated With Docetaxel Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- PSA response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Clinical or radiologic evidence of metastatic disease
- •Documented disease progression during hormone therapy (ADT plus antiandrogen) and no response to ADT withdrawal
- •Docetaxel-refractory disease defined as disease progression documented either during treatment of within 60 days after the cessation of treatment with docetaxel
- •Prior exposure to estramustine or mitoxantrone is allowed
- •No prior radioisotope therapy
- •No prior radiotherapy 25% or more of the bone marrow
- •No peripheral neuropathy grade 2 or worse
- •Adequate organ and bone marrow function
排除标准
- •Other tumor type than adenocarcinoma
- •Presence or history of CNS metastasis
- •Other serious illness or medical conditions
研究组 & 干预措施
GEMOX
GEMOX treatment
干预措施: GEMOX (Drug)
结局指标
主要结局
PSA response
时间窗: 6 months
Based on PCWG 1.0
次要结局
- PSA decline(6 months)
- Time to PSA progression(12 months)
- Composite progression-free survival(12 months)
- RECIST Response(6 months)
- Safety(6 months)
研究者
JLee
Associate Professor
Asan Medical Center