A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Rate of Toxicity
研究概览
简要总结
The goal of this clinical research study is to learn more about the safety of giving sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which they receive no drug. Researchers want to learn more about the side effects of the drug and the effects of a different dosing schedule.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take sunitinib capsules by mouth every day for 2 weeks, followed by 1 week in which you do not receive any study drug. This will then be repeated every 3 weeks.
Every 6 weeks will be 1 study cycle.
If you have any side effects tell the study doctor right away. The study doctor may change your dose of the study drug.
Study Visits:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology. Prior nephrectomy is not a requirement for eligibility
- •Age >/=18 years
- •Measurable or evaluable metastatic disease per RECIST v 1
- •ECOG performance status 0-1
- •Normal organ and bone marrow function as defined by: Serum aspartate transaminase (AST) or serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) </= 2.5 x laboratory upper limit of normal (ULN); Total serum bilirubin </= 2.0 x ULN; Absolute neutrophil count (ANC) >/= 1500/µL; Platelets >/= 100,000/µL; Hemoglobin >/= 9.0 g/dL (transfusion permitted); Serum calcium </= 12.0 mg/dL; Serum creatinine </= 2.5 mg/dL
- •Patients with a history of deep venous thromboembolism or pulmonary embolism on treatment with anticoagulation are eligible for the study.
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > 6 months prior to registration and therapy not discontinued for toxicity)
- •Uncontrolled hypertension (defined as blood pressure >140/90 mm Hg not controlled with anti-hypertensives)
- •Prior intraabdominal, intrathoracic, vascular, spinal or intracranial surgery or radiation therapy within 4 weeks of starting treatment
- •History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- •New York Heart Association (NYHA) grade II or greater congestive heart failure
- •Current treatment on another therapeutic clinical trial
- •Any of the following within the preceding 6 months- myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass, graft, cerebrovascular accident or transient ischemic attack, clinically significant bleeding
- •Pregnant or breastfeeding women are excluded from this study because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib. Breastfeeding must be discontinued if the mother is treated with sunitinib
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- •HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy
研究组 & 干预措施
Sunitinib
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
干预措施: Sunitinib (Drug)
Sunitinib
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Rate of Toxicity
时间窗: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months
Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
次要结局
- Progression-Free Survival (PFS)(17 months)
- The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event(Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.)
- Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities(2 years)
- Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)(36 weeks from the start of treatment)
- Changes in Circulating DNA Levels With Antiangiogenic Treatment(Not applicable due data not generated due to timing and budgetary issues)