A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer With Integrated Biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values
研究概览
简要总结
This phase II trial studies how well cabazitaxel and prednisone work in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
详细描述
PRIMARY OBJECTIVES:
I. To test whether men with a poor initial response to androgen deprivation therapy (ADT) have a better front line therapeutic response to cabazitaxel as compared to historical controls of frontline metastatic castrate resistant prostate cancer (CRPC) therapy with abiraterone or enzalutamide.
SECONDARY OBJECTIVES:
I. To determine the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 response rate, progression free survival (PFS) by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria, and overall survival (OS).
II. To evaluate safety and toxicity profile of cabazitaxel in patients with 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 confirmed prostate adenocarcinoma
- •Metastatic disease
- •Able and willing to provide informed consent and to comply with the study procedures
- •Castration resistant disease defined as evidence of radiological and/or prostate specific antigen (PSA) progression despite castrate levels of testosterone (serum testosterone < 50 ng/dL [1.7 nmol/L]); for PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals; the first PSA value must be >= 4 (Prostate Cancer Working Group 2 [PCWG2] criteria)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of =< 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration
- •At least 21 days have passed since receiving any investigational agent at the time of registration
- •At least 21 days have passed since major surgery
- •Neuropathy =< grade 1 at the time of registration
- •Has recovered from all therapy-related toxicity to =< grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of registration
- •Poor prognosis disease as defined by any of the following:
- •PSA nadir >=4.0, or
- •Gleason score 8-10, or
- •Time from ADT initiation to CRPC of =< 16 months
- •Hemoglobin >= 90 g/L
- •Neutrophils >= 1.5 x 10^9 /L
- •Platelets >= 100 x 10^9/L
- •Aspartate aminotransferase (AST) < 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) < 1.5 x ULN
- •Bilirubin =< 1.0 x ULN (exceptions for Gilbert's syndrome)
- •Creatinine =< 1.5 x ULN
排除标准
- •Prior therapy with cabazitaxel or to other drugs formulated with polysorbate 80
- •Prior taxanes for CRPC
- •Prior enzalutamide, abiraterone or ketoconazole
- •Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with administration of cabazitaxel, study participation, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study
- •Histologic evidence of small cell/neuroendocrine prostate cancer
- •Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose; the definition of "effective method of contraception" will be based on the investigator's judgment
研究组 & 干预措施
Treatment (cabazitaxel, prednisone)
Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Cabazitaxel (Drug)
Treatment (cabazitaxel, prednisone)
Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Prednisone (Drug)
结局指标
主要结局
PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values
时间窗: Up to 18 months.
The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method.
次要结局
- Overall Survival (OS) Defined as the Time Interval From the Date of Enrollment to the Date of Death Due to Any Cause.(Up to 18 months.)
- Progression-free Survival (PFS) Defined as the Time Interval Between the Date of Enrollment and the Date of the First Documentation by the Prostate Cancer Working Group 2 (PCWG2) Criteria.(Approximately 5 months.)
- Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03(Up to 28 days after discontinuation of study drug)
- Response Evaluation Criteria in Solid Tumors (RECIST) Response Defined as Radiographic Disease Progression(Approximately 5 months.)