Avastin & low dose IFN in nephrectomised patients with metastatic RCC

• Research type

  Research Study

• Full title

  Open-label, single-arm, phase II study of bevacizumab (AVASTIN) in combination with low-dose interferon as first-line treatment of nephrectomised patients with metastatic clear cell renal cell carcinoma

• Sponsor organisation

  F. Hoffmann-La Roche Ltd.

• Eudract number

  2007-006611-23

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Renal cell carcinoma (RCC) accounts for the majority of malignant kidney cancers and kills 100.000 people every year.Vascular endothelial growth factor (VEGF) is a human protein involved in the development of blood vessels which nurture cancer cells. Drugs which inhibit VEGF have been shown in the past to inhibit the development or growth of cancer.One of these VEGF-inhibiting molecules is bevacizumab which in previous clinical studies has shown that the length of the life of cancer patients can be improved following their treatment with this drug, especially when used in combination with interferon alpha, another naturally occuring protein with anti-cancer activity.Unfortunately interferon produces some adverse effects on some of the treated patients, and for this reason preliminary studies have been carried out using lower doses of this drug which have shown equally good therapeutic responses with lower number of adverse effects.This study has been designed to explore the efficacy and safety of treating patients with the above mentioned combination of bevacizumab and interferon alpha when using interferon at the lower dose of 3 MIU (three times a week).

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  09/H0904/12

• Date of REC Opinion

  8 Apr 2009

• REC opinion

  Further Information Favourable Opinion