NCT00430235已完成2 期
A Phase II Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- rate of PSA-response
研究概览
简要总结
Purpose:
To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer.
Hypothesis:
That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given to patients with chemo-naïve hormone-refractory prostate cancer.
详细描述
Justification:
The biologic and clinical activity and tolerability of BAY 43-9006, the therapeutic needs of the proposed patient population, and the experimental evidence in support of targeting the VEGF/VEGFR and MAPK pathways in combination with androgen receptor blockade in prostate cancer, provides a strong rationale for the proposed phase II trial to evaluate the tolerability and anti-cancer activity of combined treatment with the non-steroidal anti-androgen bicalutamide with the multi-targeted kinase inhibitor BAY 43-9006 in patients with prostate cancer that is progressing after castration therapy.
Objectives:
The primary study objective is to define the efficacy (i.e. post treatment decrement in PSA (PSA response)) of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have a histologic or cytologic diagnosis of adenocarcinoma of the prostate.
- •Patients must have low-bulk asymptomatic metastatic or biochemical recurrent disease for which no curative therapy exists.
- •Patients must have documented evidence of PSA progression while receiving androgen ablative therapy, i.e. must be hormone refractory.
- •The PSA must be > 5 μg/L at the time of study entry.
- •ECOG performance status of 0 or
- •Age 18 years of age or older
- •Patients must have a life expectancy of at least 12 weeks.
- •Chemotherapy: No prior cytotoxic chemotherapy is permissible. Neoadjuvant or adjuvant chemotherapy is permissible provided it was > 12 months prior to registration.
- •Hormonal Therapy:
- •Prior hormone therapy in the form of medical or surgical castration is required. Patients must be hormone refractory and have been previously and currently treated with androgen ablative therapy.
- •Patients may have received up to one line of non-steroidal anti- androgens in combination with chemical or surgical castration. Use of prior Bicalutamide is restricted to less than 3 months of continuous usage. Patients must be off anti-androgens for at least 6 weeks prior to study entry.
- •Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial.
- •Steroids. Current treatment with steroids ≤ an equivalent of prednisone 20 mg day is permitted.
- •Men of childbearing potential must use an effective form of contraception i.e. double barrier method.
- •Laboratory Requirements - within 7 days prior to enrollment Hematology: Hemoglobin ≥ 100g/L Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR ≤ 1.5 x upper limit of normal Biochemistry: AST, ALT within normal limits Bilirubin within normal limits Serum creatinine ≤1.5 x upper limit of normal
- •Patient consent must be obtained
- •Patients must be accessible for treatment and follow-up.
- •Protocol treatment is to begin within 5 working days of patient registration.
排除标准
- •Prior use of BAY 43-9006 or other VEGF/VEGFR or EGFR targeting agents.
- •Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for > 5 years.
- •Patients with known brain metastases or leptomeningeal disease
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006 or other agents used in the study.
- •Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment including:myocardial infarction within 6 months prior to study entry:
- •myocardial infarction within 6 months prior to study entry
- •congestive heart failure
- •unstable angina
- •cardiomyopathy
- •unstable ventricular arrhythmia
- •uncontrolled hypertension (systolic blood pressure ≥ 160, diastolic blood pressure ≥100)
- •controlled psychotic disorders
- •serious infections
- •peptic ulcer disease
- •history of bleeding diathesis
- •Upper gastrointestinal or other conditions that would preclude compliance with oral medication.
- •Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-
- •Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- •Patients who require large amounts of narcotic therapy to control pain (e.g. morphine equivalent dose > 30 mg/day) since these patients would more appropriately be offered systemic chemotherapy.
- •Patients who require therapeutic anticoagulation.
结局指标
主要结局
rate of PSA-response
次要结局
- 1 year survival rate
- objective tumor response rate
- time to PSA progression
- time to treatment failure
- median survival time
- stable disease rate as defined by the RECIST criteria,
- response duration
- incidence of toxicities by NCI CTCAE.
- duration of PSA response
研究者
研究点 (2)
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