NCT01263769已完成2 期
A Phase II Clinical Trial Examining the Impact Of Neoadjuvant Axitinib On Primary Tumor Response In Patients With Locally Advanced Clear Cell Renal Cell Carcinoma
适应症
干预措施
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
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The goal of this clinical research study is to learn if axitinib can help to control kidney cancer. The safety of this drug will also be studied.
详细描述
The Study Drug:
Axitinib is designed to decrease blood supply to the tumor, which may slow tumor growth.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take axitinib by mouth 2 times a day every day for 12 weeks. The dose may be changed based on any side effects you may have. You should take the drug about 12 hours apart. You should take the pills at about the same time each day. If you vomit anytime after taking a dose, you must not "make it up" with an extra dose, but instead take the next dose as previously scheduled. Any missed dose may be taken late up to 3 hours before the next scheduled dose, otherwise, it should be skipped.
A blood pressure monitor will be given to each participant for home use. You will be given instructions and shown how to monitor your blood pressure.
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
- •Locally advanced renal cell carcinoma without evidence of metastatic disease with absence of adjacent organ invasion or retroperitoneal adenopathy (cT2-T3b, N0, M0). Patients with retroperitoneal lymph nodes </= 2cm in size each are considered N
- •Predominant clear cell histology on pre-treatment biopsy of the primary tumor.
- •Patient should be candidate for curative radical nephrectomy.
- •ECOG Performance Status 0-
- •Patient must provide signed informed consent.
- •Male or female, age >/= 18 years.
- •Adequate renal function: serum creatinine level </=1.5 x ULN or calculated creatinine clearance (as estimated by GFR using the MDRD formula) is >/= 60 ml/min.
- •Adequate hepatic function: alkaline phosphatase </= 1.5 x ULN; total bilirubin, AST, and ALT </= 1.5 x ULN; INR <1.3 (or <3 if on anticoagulant therapy).
- •Adequate bone marrow function: ANC >/= 1.5 x 10/ 9L; Platelets >/= 100 x 109/L; Hb >9 g/dL
- •Urinary protein <100 on urinalysis (equivalent to <2+ by urine dipstick). If urinalysis protein >/=100 (equivalent to dipstick is >/=2+) then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours
- •No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy, in the 5 years prior to current study enrollment.
- •Women of childbearing potential (defined as a female subject who is not surgically sterilized, not at least 1 year postmenopausal) must have negative urine or serum pregnancy test within 4 weeks of enrollment and again on the day of starting therapy and she and/or her partner must utilize birth control while on therapy.
- •Male (defined as a male subject who has not been surgically sterilized) or female patients of child-producing potential must agree to use adequate contraception (e.g. IUD, condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: as of date of study enrollment and for at least 1 month after last dose of axitinib. Subjects who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
排除标准
- •Evidence of metastatic disease, adjacent organ invasion, retroperitoneal adenopathy on pre-treatment imaging. In addition, patients with inferior vena cava thrombi extending to the atrium or with evidence of Budd-Chiari Syndrome (hepatic dysfunction) will not be eligible for the protocol.
- •Patients who undergo embolization of their primary tumor.
- •Previous treatment for their primary renal tumor, including prior chemotherapy, immunotherapy, targeted therapy, radiation therapy, cryotherapy, radiofrequency ablation or embolization.
- •Active malignancies other than renal cell carcinoma and/or history of other malignancy within the last 5 years, except for adequately treated cone-biopsied in situ carcinoma of the cervix or basal or squamous cell carcinoma of the skin
- •Uncontrolled hypertension (BP>140/90 on medications), as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be </=140 mm Hg, and the baseline diastolic blood pressure readings must be </=90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- •Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, nefazodone, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).
- •Current use or anticipated need for treatment with drugs that are known potent CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).
- •Active gastrointestinal bleeding.
- •Malabsorption syndromes such as celiac disease, cystic fibrosis, inflammatory bowel disease, systemic sclerosis, and carcinoid syndrome.
- •Known HIV or Hepatitis C status.
- •Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
- •Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
- •A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
- •Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism
- •Withdrawal of consent.
- •Unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen.
研究组 & 干预措施
Axitinib
Experimental
Axitinib Starting dose: 5 mg by mouth twice each day for 12 weeks.
干预措施: Axitinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 12 weeks
Objective response rate is defined as Complete Response (CR)+ Partial Response (PR) and evaluated when CT abdomen is done after 12 weeks of treatment. Per Response Evaluation Criteria in Solid Tumors Criteria ( RECIST v1.0) Complete Response (CR) is complete disappearance of renal mass; and, Partial Response (PR) is \>= 30% decrease in the largest diameter (LD) of the renal mass taking as reference the baseline largest diameter.
次要结局
- Recurrence Free Survival(After completion of treatment, patients followed w/evaluations every 4 months for 1st year, then every 6 months for next 2 years, yearly until disease progression identified or start of new treatment & yearly survival thereafter until study completion)
- Overall Survival(From date of randomization until the date of death from any cause, or date of last follow-up, whichever came first, assessed up to 5 years)
- Postoperative Complications-Any Grade(From surgery until 30 days after surgery)
- Surgery-related Complications - High Grade(From surgery until 30 days after surgery)
研究者
研究点 (1)
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