NCT00599313已完成2 期
Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-based Chemotherapy
US Oncology Research42 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 42
- 主要终点
- Median Progression-free Survival (PFS) Time at 1-year.
研究概览
简要总结
The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.
详细描述
The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC.
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
- •A patient will be eligible for inclusion in this study if he meets all of the following criteria:
- •Histologically confirmed, adenocarcinoma of the prostate
- •Stage IV(metastatic) disease, documented on CT, MRI, or X-ray
- •Progressive disease (PSA or clinical): PSA progression defined as baseline increase followed by any serial increase after 2 weeks; clinical progression by symptomatic or radiologic criteria.
- •An elevated PSA level of for patients progressing by PSA criteria is required
- •Currently on androgen ablation hormone therapy (an LHRH agonist or orchiectomy) with testosterone level <50ng/dL)
- •Has received 1 or 2 prior chemotherapy regimens (no more than 2). One prior regimen must be docetaxel.
- •Has an ECOG Performance Status (PS) 0-2
- •Is greater than 18 years of age
- •Meets protocol defined laboratory values
- •Has adequate cardiac function in the opinion of the Investigator
- •Has no uncontrolled arrhythmia or hypertension
- •Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE Version 3.0 Grade less than 1, in the opinion of the Treating Physician
- •If fertile, patient has agreed to use an acceptable method of birth control to prevent pregnancy for the duration of the study and for a period of 2 months thereafter
- •Has signed a Patient Informed Consent Form
- •Has signed a Patient Authorization Form
排除标准
- •A patient will be excluded from this study if he meets any of the following criteria:
- •Has any disease other than that described in inclusion criterion #1
- •Had prior treatment with Sutent
- •Has not received prior docetaxel for the current disease
- •Has received any prior radionuclide therapy
- •Has received prior radiation to >50% of the bone marrow
- •Is receiving concurrent immunotherapy
- •Has a history of hypersensitivity to any of the components of Sutent: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients. The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The caramel gelatin capsule shells also contain yellow iron oxide and black iron oxide. The printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide.
- •Has had significant bleeding in previous 4 weeks
- •Has had any of the following within the prior 6 months: severe/unstable angina, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism
- •Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult
- •Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 4 weeks prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
- •Has uncontrolled arrhythmia or hypertension
- •Has evidence of uncontrolled CNS involvement (previous radiation and off steroids is acceptable)
- •Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
- •Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
- •Is unable to comply with requirements of study
研究组 & 干预措施
Sunitinib Malate
Experimental
Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
干预措施: Sunitinib (Drug)
结局指标
主要结局
Median Progression-free Survival (PFS) Time at 1-year.
时间窗: 12 months
PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Overal Survival (OS) Rate at 1-year.(12 months)
- Prostate Specific Antigen (PSA) Response(Baseline and up to 12 months)
- Change of PSA Doubling Time(Baseline and up to 12 months)
- Objective Response Rate (ORR)(12 months)
- Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.(Baseline and up to 12 months)
研究者
研究点 (42)
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