Phase II Non-Randomized Pre-Surgical Study Evaluating Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC) Who Are Eligible for Cytoreductive Nephrectomy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will also be studied.
详细描述
The Study Drug:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Study Treatment:
If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row, followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment.
During Cycle 2, you will have surgery to remove the tumor. You will start taking sunitinib malate again after surgery (at least 14 days after surgery) on the same schedule as before.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy. The determination of resectability will ultimately lie in the clinical judgment of the urologist and medical oncologist involved in the care of the patient.
- •2. Measurable disease is defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures \>/= 20 mm with conventional techniques or \>/= 10 mm with spiral CT scan. This does not include primary tumors, which will be removed.
- •3. ECOG performance status \/= 1,500/microL b) platelets \>/= 75,000/microL c) Hgb \> 9.0 g/dL (may be transfused or receive epoetin alfa \[e.g., Epogen®\] to maintain this level) d) total bilirubin \
排除标准
- •Patients must not have organ allografts.
- •Patients must not have had major surgical procedure, open biopsy, or significant traumatic injury within 14 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study (other than defined by protocol); or fine needle aspirations or core biopsies within 7 days prior to Day
- •No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.
- •Patients must not have received any prior anticancer therapy for renal cell carcinoma. Radiation therapy is allowed if > 2 weeks from study drug administration.
- •Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to be on concomitant bisphosphonates and megestrol acetate.
- •Patients must not have a primary brain tumor (excluding meningiomas other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, history of stroke within the past year.
- •History of serious systemic disease, including myocardial infarction or unstable angina within the last 12 months, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (blood pressure of > 140/90 mmHg) at the time of enrollment, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease.
- •Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- •Patients receiving any concomitant systemic therapy for renal cell cancer are excluded, but patients taking bisphosphonates and megestrol acetate are not excluded.
- •Patients must not require total parenteral nutrition with lipids.
- •Patients must not have clinical history of coagulopathy, bleeding diathesis or thrombosis within the past year.
- •Patients must not have serious, non-healing wound, ulcer, or bone fracture.
- •Pregnancy (positive pregnancy test) or lactation.
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
- •Know hypersensitivity to any component of sunitinib.
研究组 & 干预措施
Sunitinib + Nephrectomy
Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.
干预措施: Sunitinib (Drug)
Sunitinib + Nephrectomy
Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.
干预措施: Nephrectomy (Procedure)
结局指标
主要结局
Time to progression (TTP)
时间窗: Baseline start of treatment to disease progression; up to 5 years
TTP is defined as the time interval between treatment starts and disease progression or death, whichever occurred first, assessed each cycle (42 days).
Toxicity of Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)
时间窗: Start of study drug up to 30 days after study drug stopped
Toxicity defined as any Grade 3 or greater perioperative complications attributable to sunitinib.
次要结局
未报告次要终点