non metastatic renal tumors (RCC) MedDRA version: 9.1 Level: LLT Classification code 10038407 Term: Renal cell cancer
Conditions
Interventions
Trade Name: Nexavar®
Product Name: Nexavar®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sorafenib
CAS Number: 475207-59-1
Current Sponsor code: Nexavar
Other descriptive name: Sorafenib
Co
Sponsors
University Clinic of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with stage I / II or III renal cell carcinoma who are eligible for curative standard surgery of the primary tumor without any prior treatment at or immediately after primary diagnosis • At least 18 years of age • Sufficient bone marrow function: neutrophils > 1500/µl, hemoglobin >10 g/dl, and platelets > 100x109/l • Patients with performance status of ECOG = 1 • AST and ALT = 2.5 x ULN (= 5 x ULN for patients with liver involvement of their cancer), total bilirubin = 1.5 x ULN; alkaline phosphatase = 4 x ULN, PT-INR/PT /= 40 ml • Ability of subject to understand character and individual consequences of the clinical trial • Given written informed consent with the federal and institutional guidelines before any study treatment • Life expectancy of at least 12 weeks • Women and men with reproductive potential enrolled in this trial must use safe and effective barrier birth control measures during the course of the trial and for at least three months after the last administration of Sorafenib 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
Exclusion criteria
Exclusion criteria: • History of cardiac disease: congestive heart failure (NYHA II-IV), active CAD (MI more than 6 months prior to study entry is allowed), cardiac arrhythmias requiring antiarrhythmic therapy (betablockers or digoxin are permitted) or uncontrolled hypertension • History of wound healing complications • History of HIV infection or chronic hepatitis B or C • Active clinically serious infections (> Grade 2 NCI-CTC version 3.0) • Symptomatic brain metastasis or meningeal tumors • Pregnant or brest feeding women • Patients with seizure disorders requiring medication (such as steroids or antiepileptics) • History of organ allograft • Patients with evidence or history of bleeding diathesis • Patients undergoing renal dialysis • Known or suspected allergy or hypersensitivity to the investigational agent or to any excipient present in the pharmaceutical form or any agent given in association with this trial Excluded therapies and medications, previous and concommitant • Prior systemic therapy for RCC • Prior surgery for RCC (RCC resection as part of study permitted). Major other surgery within 4 weeks prior to start of study or incomplete wound healing from previous other major surgery. • Radiotherapy during study or within 3 weeks of start of study drug • Enrollment in another clinical trial within the last 4 weeks • Severe renal impairment that does not allow MR Contrast agents (glomerular filtration rate <30 mL/min/1.73m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the gene expression profiles (RNA and protein expression) of primary RCC tumor after neoadjuvant Sorafenib treatment compared with placebo treatment - To determine safety profile of neoadjuvant and adjuvant Sorafenib with respect to hemorrhage as well as wound healing after performing surgery for renal cell cancer;Secondary Objective: - To determine early susceptibility of RCC to Sorafenib by radiological volumetry as compared to assessment by RECIST - To determine early susceptibility of RCC to Sorafenib by MRI with Vasovist® after randomization and immediately prior to RCC resection - To determine effect of preoperative Sorafenib therapy on intra-tumor vasculature density and necrosis volume in the resected material - To assess treatment effects on other tissue biomarkers and blood biomarkers - To determine the concentration of circulating RCC tumor cells in peripheral blood prior to Sorafenib during Sorafenib therapy prior to surgery, during surgery, after surgery and at study end. - Tissue biomarker results will be correlated with imaging results in both groups - To determine safety of Sorafenib - To determine the relapse rate 2 years after surgery, in particular progression free survival ;Primary end point(s): The aim of this study is to demonstrate that neoadjuvant/adjuvant therapy with Sorafenib has an effect on non metastatic renal tumors prior to surgery be it radiologically or by gene expression, on tumor cells in blood prior, during and post surgery and on progression-free survival (only descriptive) Primary Objective: • To compare the gene expression profiles (RNA and protein expression) of primary RCC tumor after neoadjuvant Sorafenib treatment compared with placebo treatment • To determine safety profile of neoadjuvant and adjuvant Sorafenib with respect to hemorrhage as well as wound healing after performing surgery for renal cell cancer | — |
Countries
Germany
Outcome results
None listed