| Chief Investigator: |
Dr Emilio Porfiri |
| Sponsor: |
University of Birmingham |
| Funder: |
Norvartis and endorsed by CTAAC and the NCRI Renal Clinical Studies Group |
| Disease Site: |
Renal Cell Carcinoma |
| Trial Type: |
Phase II Clinical Trial of an Investigational Medicinal Product |
| Status: |
Open |
| UKCRN Study ID (if applicable): |
|
| ISRCTN Referance Number: |
38957238 |
| Open to New Sites? |
No |
| Recruitment Start Date: |
24-Aug-2012 |
| Anticipated Recruitment End Date: |
August 2016
|
| CRCTU Trial Management Team: |
Late Phase Trial Management Team - A |
| Trial Email Address: |
pazo2@trials.bham.ac.uk |
Trial Summary
- View Trial Summary Document
Approximately a quarter of patients with advanced renal cancer present with symptoms which affect their quality of life and their ability to carry on their daily routine. These are patients with poor `performance status`, their prognosis is poor and they are often deemed unsuitable for treatment because of short life expectancy of renal cancer patients with poor prognosis, but two thirds of the patients treated with this drug develop severe side effects. In addition temsirolimus requires frequent hospital visits as it is administered in weekly intravenous infusions. Temsirolimus is not recommended by the National Institute for Clinical Excellence (NICE) and is not routinely available from the NHS. Pazopanib is a new oral drug for the treatment of renal cancer which has shown efficacy in patients with good performance status. Pazopanib is well tolerated and causes fewer severe side effects compared with other drugs of the same family. Pazopanib could represent a valuable treatment option for renal cancer patients with poor performance status as it could provide a substantial clinical benefit without affecting quality of life. Our clinical trial will assess the safety and efficacy of pazopanib in renal cancer patients with poor performance status. The trial will be conducted in 10 NHS hospitals in the UK. Patients with advanced renal cancer of the clear cell type and a poor `performance status` who have not had any previous medical treatment for cancer will be eligible. The trial will be opened to recruitment for 2 years and we are planning to recruit 75 patients. All patients will commence treatment with pazopanib after initial CT-scans and bone scan. Further CT-scans will be done during the treatment which will continue until progression of the tumour.
Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.
Trial Protocol
- View Trial Protocol Document
Please Note:
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website (see the link below).
Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.