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
- Conditions
- Metastatic renal cell cancer
- Registration Number
- EUCTR2005-006161-13-DE
- Lead Sponsor
- Roche Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To asses the efficacy of the combination therapy with interferon alfa-2a, vinblastine and bevacizumab in patients with metastatic renal cell carcinoma (RCC) based on progression free survival.;Primary end point(s): Median progression free survival (PFS). Progression is defined according to RECIST criteria. ;Secondary Objective: - To characterise the safety profile of the combination of bevacizumab with interferon alfa-2a and vinblastine based on the rate of adverse events with CTCAEv3.0 Grade 3, 4 or 5.<br>- To determine the feasibility of the combination of bevacizumab and interferon alfa-2a and vinblastine.<br>- To evaluate the course of blood pressure.<br>- To assess the efficacy of the combination based on overall survival.<br>- To determine the response rate of the combination based on the RECIST criteria.
- Secondary Outcome Measures
Name Time Method