A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Patient preference
研究概览
简要总结
Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles.
Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting.
The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib.
A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future.
Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Affiliated to a social security regimen ;
- •Male patients older than 18 years ;
- •Histologically confirmed adenocarcinoma of the prostate ;
- •Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ;
- •Serum testosterone <0.50 ng/ml (1.7 nmol/L) ;
- •Progressive disease (PSA progression or radiological progression or clinical progression) ;
- •ECOG 0-2 ;
- •Information delivered to patient and informed consent form signed by the patient or his legal representative ;
- •Adequate organ or bone marrow function as evidenced by:
- •Hemoglobin >/= 10 g/dL
- •Absolute neutrophil count >/=1.5 x 109/L,
- •Platelet count >/=100 x 109/L,
- •AST/SGOT and/or ALT/SGPT </=1.5 x ULN;
- •Total bilirubin </=1.5 x ULN,
- •Serum creatinine </=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded
排除标准
- •Patients having received an investigational drug and/or prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior enrolment in the study, excepted radiotherapy directed to a single bone lesions which is nonacceptable if within 2 weeks ;
- •Prior treatment with Taxotere or Jevtana ;
- •Pre-existing symptomatic peripheral neuropathy grade > 2 (CTCAE V4) ;
- •Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed ;
- •History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ;
- •Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus), active infection including HIV infection, active Hepatitis B or C infection that would preclude participation in the trial ;
- •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) ;
研究组 & 干预措施
Do/Ca
Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles
干预措施: Jevtana (Drug)
Ca/Do
Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles
干预措施: Taxotere (Drug)
Ca/Do
Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles
干预措施: Jevtana (Drug)
Do/Ca
Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles
干预措施: Taxotere (Drug)
结局指标
主要结局
Patient preference
时间窗: Assessed up 21 weeks after randomization
Patient preference (Taxotere versus Jevtana) assessed by a single question after completion of the second period of chemotherapy. Primary outcome measure will be assessed in the intent-to-treat population as defined by all patients having completed the first 4 cycles without progression and having received at least 1 cycle of the second treatment period. Patients having progressed during the first period will discontinue the trial.
次要结局
未报告次要终点