ABC-03
Research type
Research Study
Full title
ABC-03: A randomised phase II trial of cediranib (AZD2171) or placebo in combination with cisplatin/gemcitabine chemotherapy for patients with Advanced Biliary tract Cancers
IRAS ID
22241
Contact name
Juan Valle
Contact email
Sponsor organisation
University College London
Eudract number
2009-013408-30
ISRCTN Number
to be obtained
Clinicaltrials.gov Identifier
Research summary
There are approximately 1500 cases of biliary tract cancer (BTC) in the UK every year and mortality rates have risen steadily over the past 30 years. Surgery is currently the only curative treatment but is only possible in approx 20% of cases. Selected case series report poor 5-year survival rates varying from 9-30%.The remaining 80% of unresectable cases require palliation of symptoms and treatment with other modalities.How best to palliate these patients has been poorly informed. We have published the results of the ABC-02 trial in the NEJM (1273,362;14,2010), which has defined cisplatin/gemcitabine (CisGem) as the new global standard of care. This is based on an improved overall survival in the CisGem arm of 11.7 vs. 8.2 months in the gemcitabine monotherapy (log rank p=0.002). There was also an improved progression free survival for GemCis (2 months).This new standard of care gives us a platform on which to introduce novel agents such as VEGFR-inhibitors (Vascular Endothelial Growth Factor) in order to enhance the activity of chemotherapy. Current data suggesting a role for angiogenesis (tumour blood vessel growth) in BTC is strong. VEGF-C is thought to be key in angiogenesis (Duff 2006) and is over-expressed in BTC. ABC-03 will look at adding a novel VEGF inhibitor, cediranib, to the CisGem regimen used in ABC-02, using PFS as the main trial outcome. This will be a phase II randomised, double blind, placebo controlled trial which aims to recruit 136 patients over two years within the UK.Anti-angiogenic therapies have an established role in other GI malignancies and ABC-03 provides an opportunity to demonstrate of proof of principle of the activity of cediranib in this family of malignancies. The trial is funded by Cancer Research UK and Astra Zeneca and will be coordinated by the CR UK & UCL Cancer Trial Centre.
REC name
North West - Haydock Research Ethics Committee
REC reference
10/H1010/42
Date of REC Opinion
23 Aug 2010
REC opinion
Further Information Favourable Opinion