NCT01122615已完成1 期
Phase I Trial of Sunitinib Plus Temsirolimus in Patients With Metastatic Renal Cell Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Sunitinib and Temsirolimus
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of the combination of sunitinib and temsirolimus that can be given to patients with metastatic kidney cancer.
详细描述
The Study Drugs:
Sunitinib is designed to block pathways that control important events (such as the growth of blood vessels) that are essential for the growth of cancer.
Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of sunitinib and temsirolimus based on when you joined this study. There will be 2 stages in this study.
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
- •Patients with confirmed metastatic RCC of any histological subtype
- •Patients must have evaluable disease
- •Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of these targeted agents in patients < 18 years of age, children will be excluded from this study. RCC in patients < 18 is exceedingly rare in any event.
- •Eastern Cooperative Oncology Group (ECOG) performance status </= 1
- •Patients must have adequate organ and marrow function within 14 days as defined below: a) Absolute neutrophil count >/= 1,500/µL; b) Platelet count >/= 100,000/µL; c) Hemoglobin >/= 9.0 g/dL (may be transfused to maintain or exceed this level); d) Total bilirubin </= 2.0 mg/dl; e) Albumin > 2.5 g/dL; f) Serum creatinine </= 2.0 mg/dl; g) AST (SGOT) and ALT (SGPT) </= 2.5 times the institutional upper limit of normal for subjects without evidence of liver metastases; h) AST (SGOT) and ALT (SGPT) </= 5 times the institutional upper limit of normal for subjects with documented liver metastases
- •Female patients of childbearing potential must have a normal serum beta human chorionic gonadotropin (beta-hCG) within 24 hours prior to beginning treatment on the study due to the possible teratogenic effect.
- •Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
- •Patients must give written informed consent prior to initiation of study-related procedures. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
- •Patients must be able to swallow pills
- •Both men and women and members of all races and ethnic groups are eligible for this trial
排除标准
- •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 definitively treated and disease free for 2 years. Patients with controlled brain metastases are eligible.
- •Patients must not be scheduled to receive another anticancer drug while on this study. Patients are permitted to be on concomitant bisphosphonates or megestrol acetate
- •Patients must not have had a stroke or TIA within 6 months
- •Patients must not have uncontrolled infections that could be worsened by anticancer therapy or interfere with this study
- •Patients must not have clinically significant cardiovascular disease, defined as myocardial infarction (or unstable angina) within 6 months, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory to medical management, or peripheral vascular disease (Grade III or greater)
- •Patients must not have uncontrolled hypertension, defined as > 140/90 in either systolic or diastolic component (treatment of hypertension with medications is permitted)
- •Symptomatic peripheral vascular disease
- •Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breast-feeding should be discontinued if the mother is enrolled on this trial
- •Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with some of these agents
- •Patients must not have a clinical history of coagulopathy or bleeding diathesis
- •Concomitant treatment with rifampin, St. John's wort, or the cytochrome p450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital) or CYP3A4 inhibitors is not recommended on this study.
- •Patients with significant baseline proteinuria defined as > grade 2 by screening U/A will be excluded if they have > 2 g protein by urine protein over creatinine (UPC) ratio
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device within 7 days prior to study enrollment
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- •Non-healing wound, ulcer, or bone fracture
- •Known hypersensitivity to any component of sunitinib malate, or temsirolimus
研究组 & 干预措施
Sunitinib + Temsirolimus
Experimental
Sunitinib 12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle. Temsirolimus 6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.
干预措施: Sunitinib (Drug)
Sunitinib + Temsirolimus
Experimental
Sunitinib 12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle. Temsirolimus 6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.
干预措施: Temsirolimus (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Sunitinib and Temsirolimus
时间窗: 21 days
Determination of MTD based on the occurrence of dose limiting toxicities (DLTs) during cycle one only after administration of study drugs on day one through day 21. All toxicity graded according to criteria of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 3.0.
次要结局
- Response Rate(6 weeks)
研究者
研究点 (1)
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