A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)
试验速览
- 阶段
- 不适用
- 入组人数
- 95
- 试验地点
- 9
- 主要终点
- Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
研究概览
简要总结
The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to surgery (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five patients will be recruited into his study.
详细描述
This is a Phase II, open label study evaluating pre-operative pazopanib treatment in previously untreated patients with metastatic clear cell renal cancer. This study follows a Simon 2 stage design
Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue after nephrectomy until disease progression is documented. Patients will come off study once disease progression occurs, where they will then be followed for survival. Subsequent treatment at the discretion of the treating physician will be documented.
After surgery, all patients will be radiologically evaluated 8 weekly until progression. Standard radical nephrectomy with lymph node dissection will be performed on those patients who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Histopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST v1.1). Only a component of clear cell is required.
- •No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions.
- •Adequate organ function as defined by the following criteria:
- •i. Total serum bilirubin ≤1.5 x uln (patients with gilbert's disease exempt) ii. Serum transaminases (ALT) <3 x uln iii. Calculated creatinine clearance >30ml/min iv. Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support v. Platelets ≥ 75,000/mm3
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- •Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- •ECOG performance status of 0, 1 or
- •18 years or above (no upper age limit) Male or female
排除标准
- •Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication.
- •Previous treatment for renal cancer
- •Pregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy.
- •Male patients must be surgically sterile or agree to use adequate contraception during the period of therapy.
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
- •Prolonged QT interval >480msecs or a history of prolonged QT interval >480msecs
- •Ongoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease.
- •Bleeding diathesis
- •Current uncontrolled hypertension
- •Another malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.
结局指标
主要结局
Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
时间窗: Interim analysis after 34 patients have 12 weeks of treatment
12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.
次要结局
- Surgical complications (blood loss, post operative complications, hospital stay)(After the first 20 patients have had a nephrectomy)
- Overall Survival(After three years of study)
- Progression free survival(After all patients have progresssed)
- Local response of primary tumour to pazopanib(After 12 weeks of study drug)
研究者
Centre of Experimental Medicine
Thomas Powles
Queen Mary University of London