A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Prostate-specific Antigen (PSA) Level
研究概览
简要总结
The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.
详细描述
Docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant prostate cancer (CRPC) but duration of response is limited, with median time to prostate-specific antigen (PSA) progression of 6-8 months. There is currently no standard second-line therapy for patients who have progressed after receiving docetaxel. Carboplatin and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this regimen are limited. In addition, correlative studies investigating why some patients respond are lacking.
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 or cytologic diagnosis of prostate carcinoma.
- •Subject must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. Furthermore, if applicable, medical castration must be maintained for the duration of the protocol.
- •Serum testosterone < 50 ng/ml.
- •Subjects who have received anti-androgen therapy with a resulting PSA decline must demonstrate progression following discontinuation of anti-androgen therapy.
- •Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
- •Must have previously received docetaxel for prostate cancer
- •ECOG performance status 0-2
- •Willing and able to give informed consent
排除标准
- •Platelet count <100,000/mm3
- •Absolute neutrophil count (ANC) <1,500/mm3
- •Hemoglobin < 8 g/dL
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal
- •Bilirubin (total) >2 x upper limit of normal. Subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits
- •For subjects with serum creatinine > 1.5 x ULN, calculated creatinine clearance < 30 ml/min are excluded; subjects meeting this exclusion criterion are eligible if a measured clearance is > 30 ml/min
- •Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
- •Prior investigational therapy within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase.
- •Grade > 1 peripheral neuropathy
研究组 & 干预措施
All subjects
Carboplatin and Paclitaxel
干预措施: Carboplatin (Drug)
All subjects
Carboplatin and Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Change in Prostate-specific Antigen (PSA) Level
时间窗: Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.
Change in Tumor Size
时间窗: Baseline, week 12, week 24 and end of study.
Assessed by CT or MRI scan and/or bone scan.
次要结局
- Change in Survival Status(6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.)