Pazopanib in patients with renal cancer (PaZ02)

• Research type

  Research Study

• Full title

  A study of pazopanib efficacy and safety in patients with advanced clear-cell renal cell carcinoma and ECOG Performance Status 2 (PaZ02)

• IRAS ID

  84429

• Contact name

  Emilio Porfiri

• Sponsor organisation

  University of Birmingham

• Eudract number

  2011-001211-31

• Duration of Study in the UK

  3 years, 5 months, 28 days

• Research summary

  Approximately a quarter of the patients with advanced renal cancer, present with symptoms which affect their quality of life and ability to carry on the 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 and the impact of treatment side effects. Treatment with a drug called temsirolimus can improve the survival of renal cancer patients with poor performance status however this drug causes severe side effects in two thirds of the patients. 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. Untreated patients with advanced renal 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 to assess the efficacy of pazopanib which will be continued until the tumour shows deterioration. All patients will be followed until death.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0450

• Date of REC Opinion

  24 Feb 2012

• REC opinion

  Further Information Favourable Opinion