A single center open-label uncontrolled study to investigate tumour response and vascularization changes in neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable renal cell cancer

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN46317673
• Date of registration: 14/02/2006
• Prospective Registration: Yes
• Primary sponsor: Academic Medical Center (AMC), Department of Urology (The Netherlands)
• Public title: A single center open-label uncontrolled study to investigate tumour response and vascularization changes in neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable renal cell cancer
• Date of first enrolment: 01/03/2006
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN46317673
• Study type: Interventional
• Study design: Single center open-label uncontrolled study (Treatment)

Countries of recruitment

Netherlands

Contacts

• Name: S.A. Lagerveld-Zaaijer

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients >18 years
2. Eastern Cooperative Oncology Group (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 computed tomography (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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Renal cell cancer
Cancer
Malignant neoplasm of kidney, except renal pelvis

Intervention(s)

All patients will receive BAY 43-9006 400 mg twice a day (bid) for the period of 8 weeks.

Primary Outcome(s)

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 Outcome(s)

Parameters: toxicity.
1. Toxicity by means of the remaining laboratory assessments
2. Number and severity of adverse events (AEs)
3. Number and severity of serious adverse events (SAEs)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Academic Medical Center (AMC), Department of Urology (Netherlands)