EUCTR2007-006611-23-DE进行中（未招募）不适用
Open-label, single-arm, phase II study of bevacizumab (AVASTIN®)in combination with low-dose interferon as first-line treatment ofnephrectomised patients with metastatic clear cell renal cell carcinoma - BEVLi
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent (informed consent document to be approved by the institution’s Independent Ethics Committee and consent obtained prior to any study-specific procedure) This includes: Willingness to give written informed consent, written consent for data protection (legal requirement in Germany: „datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study. For this reason patients must not be dependent on the sponsosr or investigator.
- •2. Age =18 years. This includes, that paitents must be capable to understand the aim, importnace and consequences of the sutdy and to gieve legal informed consent (excluding patients as defined in § 40 Abs. 4 adn § 41 Abs. 2 and Abs. 3 AMG)
- •3. Able to comply with the protocol. This includes, that patinets must not have a psychological illness or condition such as to interfere with the patients ability to undersatnd the requirement of the study.
- •4. Subject with histologically and/or cytologically confirmed, metastatic RCC, with majority (>50%) of conventional clear-cell type is mandatory. (Subjects with predominantly papillary or sarcomatoid features, and subjects with chromophobe, oncocytoma, collecting duct tumours, Bellini tumours or transitional cell carcinoma are not allowed). Tumours of mixed histology should be categorised by the predominant cell type.
- •5. Prior total nephrectomy for primary renal cell carcinoma. Partial nephrectomy is allowed only if the resection margins were clearly negative.
- •6. At least one measurable or non-measurable lesion (as per RECIST criteria).
- •7. Eastern Cooperative Oncology Group (ECOG) PS status 0-2 (Karnofsky Performance Status =70) (see Appendix 2 for correspondence between ECOG PS and KPS)
- •8. Good or intermediate prognosis disease as defined by Motzer score
- •9. Life expectancy =12 weeks
- •10. Adequate haematological function:
- •a. Absolute neutrophil count (ANC) =1.5 x 10 e9/L AND
- •b. Platelet count =100 x 10 e9/L AND
- •c. Haemoglobin =8 g/dL (may be obtained by the use of erythropoietin or transfusion for anaemia)
- •11. Adequate liver function:
- •a. Total bilirubin <1.5 x upper limit of normal (ULN) AND
- •b. Asparagine aminotransferase (AST), alanine aminotransferase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
- •12. Adequate renal function:
- •a. Serum creatinine =1.5 x ULN AND
- •b. Urine dipstick for proteinuria <2+. Patients with =2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate <1 g of protein in 24 hours
- •13. International normalised ratio (INR) (in absence of anticoagulation treatment) =1.5 within 7 days prior to enrolment. Anticoagulation is allowed if target INR is < 3 and if the patient is on a stable dose of anticoagulant (coumarin type, low molecular weight heparin (LMHW) or bivalirudin or argatroban) for > 2 weeks at time of enrolment.
- •14. Female patients should not be pregnant or breast-feeding. Women of child bearing potential (i.e. a woman who is biologically capable of becoming pregnant) must have a negative serum pregnancy test within 7 days prior to enrolment into the study. If a serum pregnancy test is not performed within 7 days prior to the first dose of bevacizumab, a confirmatory urine test (within 7 days prior to the first dose of bevacizumab) is required. Patients (men and women) must agree to use medically accepted contraceptive methods with their partners throughout the study and for 6
排除标准
- •1. Prior systemic treatment for metastatic RCC disease (including neo-adjuvant therapy).
- •2. Current or previously treated central nervous system (CNS) metastases or spinal cord compression
- •3. Major surgery (incl. open biopsy) or radiation therapy within 28 days prior to enrolment. (Palliative radiotherapy to painful bone lesions is not allowed within 14 days prior to enrolment). Subject must have recovered from prior surgery (> 28 days) and radiation (> 28 days - 14 days if palliative radiotherapy to painful bone lesions).
- •4. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrolment
- •5. Significant cardiovascular disease defined as congestive heart failure (NYHA Class II, III, or IV – see Appendix 3), unstable angina pectoris, or myocardial infarction within 6 months prior to enrolment.
- •6. Inadequately controlled hypertension (defined as a blood pressure of > 150 mmHg systolic and/or > 100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy
- •7. History of stroke or transient ischemic attack within 6 months prior to enrolment
- •8. Significant vascular disease (e.g., aortic aneurysm, aortic dissection), or symptomatic peripheral vascular disease
- •9. Evidence or history of recurrent thromboembolism (>1 episode of deep venous thrombosis/peripheral embolism) during the past 2 years, bleeding diathesis or coagulopathy
- •10. Chronic daily intake of aspirin >325 mg/day or clopidogrel >75 mg/day
- •11. History of abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrolment
- •12. Serious, non-healing wound, ulcer, or bone fracture
- •13. Immuno-compromised patients, including known seropositivity for human immunodeficiency virus (HIV)
- •14. Chronic treatment with corticosteroids (dose of >10 mg/day methylprednisolone equivalent) excluding inhaled steroids or substitution therapy
- •15. Known hypersensitivity to any component of the investigational drugs or excipients
- •16. Current active second malignancy other than non-melanoma skin cancers and post-treatment for localised prostate cancer. Patients are not considered to have a currently active malignancy if they are in complete remission for >3 years prior to study
- •17. Any other significant medical illness or medically significant abnormal laboratory finding that would, in the investigator’s judgment, make the patient inappropriate for this study, or would increase the risk associated with the patients’ participation in the study.
- •18. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
- •19. Prior treatment with bevacizumab for any indication. This includes prior participation in this study.
研究者
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