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

ISRCTN	ISRCTN46317673
DOI	https://doi.org/10.1186/ISRCTN46317673
Protocol serial number	N/A
Sponsor	Academic Medical Center (AMC), Department of Urology (The Netherlands)
Funder	Academic Medical Center (AMC), Department of Urology (Netherlands)

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 31/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S.A. Lagerveld-Zaaijer
Scientific

Academic Medical Center (AMC)
Department of Urology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5666030
Email	S.A.Zaaijer@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Single center open-label uncontrolled study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	In view of good pre-clinical and clinical results, it is thought that patients with renal cell cancer will benefit from BAY 43-9006 in a neoadjuvant setting. We anticipate a benefit with the treatment of BAY 43-9006 when there is a tumour reduction more than 30%.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Renal cell cancer
Intervention	All patients will receive BAY 43-9006 400 mg twice a day (bid) for the period of 8 weeks.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	BAY 43-9006 [sorafenib (Nexavar®)]
Primary outcome measure(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
Key secondary outcome measure(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)
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	01/03/2006
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan