Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy
研究概览
简要总结
This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.
详细描述
Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.
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 confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis
- •No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
- •Performance status 0-2
- •Must meet criteria for acceptable lab values as outlined in the protocol.
- •Peripheral neuropathy must be greater than or equal to 1
- •Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
排除标准
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80
研究组 & 干预措施
Experimental Arm
干预措施: Bicalutamide (Drug)
Experimental Arm
干预措施: docetaxel (Drug)
Experimental Arm
干预措施: GnRh analog (Drug)
Experimental Arm
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy
时间窗: 57 days
To determine the MTD of Taxotere with radiation therapy and hormonal therapy in patients with high risk locally advanced adenocarcinoma of the prostate. The dose limiting toxicity (CLT) period for determining the MTD is 57 days.
次要结局
未报告次要终点