A phase II study of preoperative everolimus in metastatic renal cell cancer

Royal Marsden NHS Foundation Trust (UK)0 个研究点目标入组 40 人开始时间: 2011年8月17日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•1. Histologically confirmed metastatic renal cell carcinoma
•2. At least one site of disease outside the kidney measurable per Response Evaluation Criteria In Solid Tumors (RECIST)
•3. Scheduled to undergo nephrectomy as part of treatment plan
•4. No prior systemic therapy for renal cell carcinoma
•5. Male or female, 18 years of age or older
•6. Life expectancy of 12 weeks or greater
•7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•8. Serum aspartate transaminase (AST) serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
•9. Total serum bilirubin = 1.5 x ULN
•10.Serum creatinine = 1.5 x ULN
•11. Absolute neutrophil count (ANC) = 1.5 x109/L
•12. Platelets = 100 x109/L
•13. Haemoglobin = 9.0 g/dL
•14. Prothrombin time (PT) = 1.5 x ULN
•15. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrolment
•16. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

•1. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
•2. Need for nephrectomy to relieve symptoms relating to the primary tumour or for emergency nephrectomy
•3. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
•4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
•5. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy
•6. Current signs or symptoms of severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to renal cell cancer (RCC)

发起方

Royal Marsden NHS Foundation Trust (UK)