BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Prostate-Specific Antigen (PSA) Response
研究概览
简要总结
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)
详细描述
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).
This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.
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
- •Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible.
- •All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
- •Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
- •Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is required.)
- •Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.)
- •Patients must have high risk disease defined as either:
- •Gleason Score 8-10
- •PSA > 15 ng/ml
- •Stage T3a
- •Stage T2c and Gleason score of 7
- •Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe.
- •No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.
- •Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by an urologist.
- •ECOG PS 0-1
- •Age > 18 years of age.
- •Required initial laboratory values:
- •ANC > 1500/ul
- •Platelet count > 100,000/mm3
- •Creatinine < 2.0 mg/dl
- •Serum PSA < 100 ng/ml
- •Bilirubin < upper institutional limit of normal (ULN)
- •AST/ALT < 2.5 X ULN
排除标准
- •Active or uncontrolled infection.
- •Patients must not have other coexistent medical condition that would preclude protocol therapy.
- •Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).
- •Grade 1 or greater neuropathy (motor or sensory) at study entry
研究组 & 干预措施
Ixabepilone
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study***
干预措施: Ixabepilone (Drug)
Ixabepilone
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study***
干预措施: Prostatectomy (Procedure)
结局指标
主要结局
Prostate-Specific Antigen (PSA) Response
时间窗: after 12 weeks of ixabepilone
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
次要结局
未报告次要终点