CTRI/2007/091/000033Other2 期
An Phase II, Open label,Randomized, Multicentric,Clinical Trial of Mycobacterium w in combination with Docetaxel versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 176
- 试验地点
- 28
- 主要终点
- 1. Overall Survival
研究概览
简要总结
This study will be an open label, multicentric, randomized, comparative controlled clinical trial. Patients assigned to test arm will receive Inj. Cyclophosphamide 300 mgm/m2 on day one. This will be followed by injection of Mycobacterium w on next day. Seven days following immunization Docetaxel will be administered by intravenous infusion on day 1 of a 21 days cycle for 6 cycles. Mycobacterium w will be given every 2nd & 3rd week of chemotherapy, and 30 days after last cycle subsequently for six months. Patients in control arm will receive only Docetaxel 75mg/m2 by intravenous infusion on day 1 of a 21 days cycle for 6 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Â§:Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
- •Â§:Disease progression during antiandrogen therapy, having surgical or medical castration status.
- •Â§:Karnofsky Performance Status 50-100 §:Normal cardiac function.
- •Â§:Life expectancy atleast 24 weeks §:Laboratory criteria for eligibility will include §:A neutrophil count of at least 1500 per cubic millimeter, §:A hemoglobin level of at least 9 gm%, §:A platelet count of at least 100,000 per cubic millimeter, §:A total bilirubin not greater than 1.5 times the upper limit of the normal range for each institution, §:Serum creatinine levels not more than 1.5 times the upper limit of the normal range.
- •Â§:Written informed consent.
排除标准
- •§:Prior treatment with cytotoxic agents or radioisotopes.§:Estrogen use for at least three months.§:History of another cancer within the preceding five years (except basal or squamous-cell skin cancer).§:Brain or leptomeningeal metastases.§:Symptomatic peripheral neuropathy of grade 2 or higher.§:Uncontrolled intercurrent illness that would limit compliance with study requirements.
结局指标
主要结局
1. Overall Survival
时间窗: 1. 12 months
次要结局
- 1. Quality of Life(2. PSA levels)
研究者
研究点 (28)
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