At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed clear cell metastatic renal cell carcinoma eligible for cytoreductive nephrectomy
- ✓Measurable disease: ≥20 mm with conventional imaging or ≥10 mm with spiral CT
- ✓ECOG performance status ≤1
- ✓Adequate organ and marrow function: ANC ≥1,500/µL, platelets ≥75,000/µL, Hgb >9.0 g/dL, total bilirubin ≤2.0 mg/dL, albumin >3.0 g/dL, serum creatinine ≤2.0 mg/dL
- ✕Prior systemic anticancer therapy
- ✕Brain metastases, leptomeningeal disease, or primary brain tumor (excluding meningiomas and other benign lesions)
- ✕Uncontrolled hypertension (BP >140/90 mmHg on medication) or history of hypertensive crisis/encephalopathy
- ✕NYHA Grade II or greater congestive heart failure or myocardial infarction/unstable angina within 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMab VEGF (Bevacizumab) for Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Bevacizumab for Renal Cell Carcinoma and Kidney Cancer. Completed, enrolled 52 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if bevacizumab (Avastin®) can control metastatic renal cell carcinoma (RCC). The safety of the treatment will also be studied. Objectives: Primary: 1. To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to progression. 2. Toxicities of therapy with bevacizumab in RCC. Secondary: Clinical: 1. Response rate 2. Duration of response 3. Overall Survival Preclinical: 1. Serum and plasma levels of matrix metalloproteinase 9 (MMP-9) and MMP-2, Interleukin 6 (IL-6), vascular endothelial growth factor (VEGF), and Basic Fibroblast Growth Factor (bFGF) pre- and post- therapy (optional studies). 2. Tissue expression of Phospho-epidermal growth factor receptor (EGFR), VEGF, vessel count CD31/34, AKT and Phospho-AKT, mitogen-activated protein kinase (MAPK), transforming growth factor-alpha (TGF-alpha), phospho-STAT3 and TUNEL post therapy (optional studies). 3. complementary DNA (cDNA) microarray analysis of tissue post-therapy (optional studies). 4. Tissue expression of tumor infiltrating lymphocytes and tumor antigens 5. Pathological response rate in primary tumor. 6. To evaluate the Single Nucleotide Polymorphisms (SNP) patterns in nephrectomy specimens from patients participating in the study.
Study Details
Timeline
Interventions
10 mg/kg IV on day 1 of each 14-day cycle.