A Randomized, Phase II Trial of AZD2171, Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients With Metastatic, Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- 6-month Progression-free Survival (PFS) Proportion
研究概览
简要总结
This randomized phase II trial is studying how well giving docetaxel and prednisone together with or without cediranib works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel together with prednisone, with or without cediranib, may kill more tumor cells.
详细描述
PRIMARY OBJECTIVE:
I. To determine the 6-month progression-free survival rate of patients with hormone refractory metastatic adenocarcinoma of the prostate treated with docetaxel and prednisone with vs without cediranib.
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of cediranib, docetaxel, and prednisone in patients with metastatic hormone-refractory prostate cancer.
II. To determine the duration of prostate-specific antigen (PSA) response and PSA control in patients with metastatic hormone-refractory prostate cancer treated with cediranib, docetaxel, and prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Clinical/radiologic metastases with objective evidence of disease progression by imaging or by rising prostate-specific antigen (PSA) despite androgen deprivation therapy
- •Rising PSA must be determined based on a rising trend with 2 successive elevations at a minimum interval of 1 week
- •Meets 1 of the following criteria: Measurable disease, with any level of PSA, at least 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan, nonmeasurable disease, PSA >= 5 ng/mL OR new areas of bony metastases on bone scan
- •Castrate levels of testosterone < 50 ng/dL must be maintained and documented
- •Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued, if required to maintain castrate levels of testosterone
- •Total bilirubin normal
- •Patients with radiological evidence of stable brain metastases are eligible provided they are asymptomatic and do not require corticosteroids or have been treated with corticosteroids and show clinical and radiological evidence of stabilization at least 10 days after discontinuation of steroids
- •ECOG performance status (PS) =< 2 or Karnofsky PS 60-100%
- •Life expectancy > 12 weeks
- •Leukocytes >= 3,000/mcL
- •Absolute neutrophil count >= 1,500/mcL
- •Platelet count >= 100,000/mcL
- •Histologically confirmed adenocarcinoma of the prostate
- •AST and ALT =< 2.5 times upper limit of normal
- •Creatinine normal OR creatinine clearance >= 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Proteinuria =< 1+ and urine protein:creatinine ratio =< 1.0 OR 24-hour urine protein < 1,000 mg
- •Peripheral neuropathy >= grade 2
- •Uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements
- •Congestive heart failure, second or third degree heart block, or recent myocardial infarction within the past 6 months
- •QTc prolongation > 500 msec OR other ECG abnormality noted within 14 days of treatment
- •New York Heart Association class III or IV cardiac disease; Class II disease controlled with treatment and monitoring allowed
- •History of poorly controlled hypertension (e.g., resting blood pressure > 150/90 mm Hg with or without hypertensive therapy)
- •History of a curatively treated malignancy with a survival prognosis of less than 5 years or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
- •History of significant gastrointestinal impairment, as judged by the investigator, that would significantly affect the absorption of cediranib
- •History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •Significant hemorrhage (30 mL bleeding/episode in previous 3 months) or hemoptysis (5 mL fresh blood in previous 4 weeks)
- •Prior enrollment or randomization of treatment in the present study
- •Patients must be off flutamide antiandrogen therapy for ≥ 4 weeks (6 weeks for bicalutamide or nilutamide)
- •No prior chemotherapy for metastatic prostate cancer
- •No major surgery within the past 14 days or a surgical incision that is not fully healed
- •No HIV-positive patients on combination antiretroviral therapy
- •No conditions requiring concurrent use of drugs or biologics with proarrhythmic potential
- •No other investigational agents within 30 days prior to study enrollment
- •No untreated unstable brain or meningeal metastases
- •Known hypersensitivity to cediranib or any of its excipients
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral cediranib maleate once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
干预措施: cediranib maleate (Drug)
Arm I
Patients receive oral cediranib maleate once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
干预措施: docetaxel (Drug)
Arm I
Patients receive oral cediranib maleate once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
干预措施: prednisone (Drug)
Arm I
Patients receive oral cediranib maleate once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive docetaxel and prednisone as in arm I.
干预措施: docetaxel (Drug)
Arm II
Patients receive docetaxel and prednisone as in arm I.
干预措施: prednisone (Drug)
Arm II
Patients receive docetaxel and prednisone as in arm I.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
6-month Progression-free Survival (PFS) Proportion
时间窗: Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months
The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free
次要结局
- Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group(Up to 52 weeks)
- Overall Response Rate Evaluated by the RECIST Criteria(Up to 52 weeks)
- Time to Progression(The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks)
- Overall Survival(The time from registration date until death from any cause, assessed up to 52 weeks)