All patients with renal cell cancer who are candidates for a partial or radical nephrectomy, will be asked to participate in the BAY 43-9006 study.
Conditions
Sponsors
Academic Medical Center, University of Amsterdam,
Department of Urology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients > 18 years; 2. ECOG = 1(2); 3. Candidates for a radical or partial nephrectomy who are fit for surgery; 4. At least one uni-dimensional measurable lesion, measured by CT-scan; 5. Adequate bone marrow function; 6. Adequate liver function; 7. Adequate renal function; 8. Adequate coagulation; 9. Men and women must have adequate barrier birth control before and during and for 1 week after the trial. 10.Signed informed consent
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY43- 9006; 2. History of cardiac disease congestive heart failure, cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension; 3. History of chronic hepatitis B or C and HIV infection; 4. Patients with seizure disorders (requiring medication); 5. Patients with evidence or history of bleeding diathesis; 6. Other investigational drug therapy within 30 days; 7. Women of childbearing potential with a positive pregnancy test within 7 days before start treatment; 8. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study; 9. Unable to swallow oral medication; 10. Tumour/ disease specific criteria: chronic diarrhoea, bowel obstruction, degree of malnutrition, malabsorption; 11. Major surgery within 4 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters: tumour response and vascularization. 1. Tumour reduction measured by CT; 2. Quantitative changes in perfusion as measured by means of contrast enhanced ultrasound and various image processing techniques. | — |
Secondary
| Measure | Time frame |
|---|---|
| Parameters: toxicity. 1. Toxicity by means of the remaining laboratory assessments; 2. Number and severity of AEs; 3. Number and severity of SAEs. | — |
Contacts
Public ContactS.A. Zaaijer
Academic medical Center (AMC) Department of Urology P.O. Box 22660
Outcome results
None listed