PAZOFOS
Research type
Research Study
Full title
PAZOFOS: A Phase Ib and Randomised Phase II Trial of Pazopanib with or without Fosbretabulin in Advanced Recurrent Ovarian Cancer
IRAS ID
133335
Contact name
Gordon Jayson
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Eudract number
2013-005471-40
ISRCTN Number
ISRCTN30090285
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 2 months, 6 days
Research summary
Ovarian cancer is the fourth biggest contributor to female cancer mortality, accounting for 4% of all malignancies diagnosed in women. In the United Kingdom (UK), there are seven thousand new cases of ovarian cancer annually and four thousand two hundred deaths from the disease. The standard treatment approach currently consists of surgical debulking and chemotherapy, usually based around a combination of carboplatin and paclitaxel. Most ovarian cancers are initially chemo-responsive, however, the majority of patients whose disease initially responds subsequently develop recurrent disease.
Angiogenesis, the process where new blood vessels form has been validated as a target in ovarian cancer in four randomised trials, they showed that the addition of vascular endothelial growth factor (VEGF) inhibitors to conventional cytotoxic therapy in the first line, platinum-sensitive and recurrent settings improves progression free survival (PFS). This approach while statistically significant only results in a modest improvement in PRS and further improvements in survival times are needed.
Vascular disrupting agents (VDA) are drugs that cause acute vascular collapse in tumours but the clinical benefit is overcome by the rapid recovery of the vasculature. The addition of a VEGF pathway inhibitor to a VDA should prevent this recovery and in this trial we will evaluate the activity of such a combination.
The VDA fosbretabulin and the VEGF receptor tyrosine kinase inhibitor pazopanib will be used in this trial for the first time in combination.
In the first part of this study (phase Ib) we will establish the appropriate doses fosbretabulin and pazopanib, when given in combination. In the second part of the study (phase II) we will compare the clinical activity of pazopanib alone with the combination of pazopanib with fosbretabulin. The primary endpoint will be the median progression free survival.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0196
Date of REC Opinion
8 May 2014
REC opinion
Further Information Favourable Opinion