EUCTR2005-006161-13-DE进行中（未招募）不适用
A single arm Phase II study to assess efficacy and safety of bevacizumab in combination with the standard therapy (interferon alfa-2a and vinblastine) as first-line treatment for patients with metastatic renal cell cancer (Bevacizumab with standard therapy in RCC) - Bevacizumab with standard therapy in RCC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Willingness to give written informed consent for study participation and for data protection (legal requirement in Germany: ‘Datenschutzrechtliche Einwilligung’).
- •Patient must be willing and able to comply with the protocol.
- •Patients with metastatic renal cell carcinoma of predominantly clear cell type with at least one measurable lesion according to RECIST criteria.
- •Patient was nephrectomized for primary clear cell renal cell carcinoma and postsurgical wound healing is completed..
- •Age = 18 years.
- •ECOG Performance status = 2.
- •The required laboratory values at screening are as follows:
- •Hematology:
- •- Absolute neutrophil count = 1.5 x 109/L
- •- Platelet count > 100 x 109/L.
- •- Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level).
- •- International Normalized Ratio (INR) = 1.5 x upper limit of normal (ULN); aPTT = 1.5 x ULN.
- •Biochemistry:
- •- Total bilirubin = 1.5 x ULN.
- •- AST, ALT = 2.5 x ULN in patients without liver metastases; < 5 x ULN in patients with liver metastases.
- •- Serum creatinine < 2.0 mg/dL or 177 µmol/L or calculated creatinine clearance = 35 mL/min.
- •Absence of proteinuria at baseline defined as:
- •- Patients with < 1+ proteinuria on dipstick urinalysis.
- •- Patients with = 1+ proteinuria on dipstick urinalysis, who demonstrate < 0.5 g of protein/24 h on 24-h urine collection.
- •Life expectancy greater than 3 months.
- •Evaluation of tumor-manifestation 4 weeks or less before start of therapy by RECIST criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for RCC (including neo-adjuvant or adjuvant therapy).
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
- •Serious non-healing wound, ulcer or bone fracture.
- •Evidence of bleeding diathesis or coagulopathy.
- •Hemapoetic diseases.
- •Serious dysfunction of bone marrow.
- •History or other evidence of ischemic retinopathy.
- •Uncontrolled thyroid disease.
- •Uncontrolled hypertension.
- •Contraindications of the standard therapy (interferon alfa-2a and vinblastine).
- •Seizure(s) not controlled with standard medical therapy.
- •Ongoing or recent (within 10 days prior to study treatment start) need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin (> 325 mg/day).
- •Patients with a medical condition requiring chronic systemic corticosteroids at a dosage of > 10 mg/kg BW methylprednisolone equivalent, excluding inhaled steroids.
- •History or presence of other malignancies within the last 5 years (except: cervical carcinoma in situ and basal cell or squamous cell carcinoma of the skin).
- •Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade = II congestive heart failure, or serious cardiac arrhythmia requiring medication.
- •Women, lactating, pregnant or of childbearing potential and fertile men not using a highly effective contraceptive method (Allowed methods of birth control, i.e. with a failure rate of = 1% per year, are implants, injectables, combined oral contraceptives intrauterine devices (only hormone spirals), sexual abstinence or vasectomized partner for up to 6 months after end of treatment). [Women of childbearing potential must have a negative pregnancy test (serum ß-HCG) within 7 days before the first dose of study drug].
- •Evidence of current central nervous system (CNS) metastases or spinal cord compression. If clinically indicated, patient must undergo a MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to inclusion.
- •Known infection with HBC, HCV, HIV (no testing required)
- •History or presence of autoimmune disease (i.e. thyroid autoimmune dysfunction).
- •Uncontrolled bacterial infection of any kind.
- •Evidence of allergy or hypersensitivity against the used medication and its ingredients.
- •Allogenic transplants with a need for immunosuppressive therapy.
- •History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
- •History or presence of a neuromuscular disease.
- •Recent (within the 30 days prior to inclusion) treatment with another investigational drug or recent/current participation in another investigational study.
- •Patients who have participated in this study before.
- •Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4, § 41 Abs. 2 and Abs. 3 AM
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