NABNEC

Protocol title:     A Randomised Phase II Study Of nab-paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas

Study Chair:   Dr Mustafa Khasraw, (Northern Cancer Institute, Sydney)

Associate Oncology Program Manager:    Cheryl Friend

 Trial Coordinator:    Uzma Rayani

 Contact Email: nabnec@ctc.usyd.edu.au

Detailed information  available  on:  Australian and New Zealand Clinical Trials Registry – NABNEC

Trial Newsletter: None to date

Grants Awarded: NHMRC Grant: $1,393,083  (2015)

Aims: To establish if carboplatin and nab-paclitaxel combination is an effective and tolerable chemotherapy treatment for grade 3 advanced gastrointestinal NECs. To explore translational biologic, molecular and functional imaging endpoints to inform future research and improve outcomes for NEC patients.

Background: Neuroendocrine carcinomas (NEC, WHO grade 3), comprising small cell NEC and large cell NEC, are aggressive rare cancers and are generally rapidly fatal. They arise commonly in the gastrointestinal system. There have been a few retrospective studies but no randomised, prospective controlled trials conducted to establish gold standard chemotherapy for advanced gastrointestinal NECs. Etoposide and carboplatin are historical standard of care by extrapolation from small cell lung cancer trials. Paclitaxel and carboplatin are active in gastrointestinal NECs but there is no data on the role of nab-paclitaxel. This randomised study will determine the role of these therapies in clinical practice and to prospectively study the biology and imaging characteristics of NEC.

Study Design: Non-comparative phase II randomised (2:1) stratified multicentre clinical trial.   Randomisation will be performed using the method of minimisation. Patients will be stratified in a 2:1 ratio by study site, Ki-67 (<55% v ≥ 55%), primary site (pancreatic vs non-pancreatic) and FDG-PET uptake and/or avidity (<10 v >10).     The sample size is 70.

To view study schema  click here.

Participating Centres:

Site Name State Principal Investigator  Site activated
Northern Cancer Institute, St Leonards NSW Dr Nick Pavlakis Active
Royal North Shore Hospital NSW Dr Mustafa Khasraw Active
Westmead Hospital NSW Dr Adnan Nagrial Active
St Vincent’s Hospital (Sydney) NSW Dr Lorraine Chantrill Not yet activated
St George Hospital NSW Dr Katrin Sjoquist Active
Calvary Mater Newcastle Hospital NSW Dr James Lynam Active
Peter MacCallum Cancer Centre (previously Royal Melbourne Hospital) VIC Dr Lara Lipton Not yet activated
University Hospital Geelong VIC Dr Inger Olesen Active
Border Medical Oncology VIC Dr Craig Underhill Not yet activated
Monash Medical Centre – Moorabbin VIC Dr Ben Markman Active
Flinders Medical Centre SA A/Prof Chris Karapetis Not yet activated
St John of God Hospital Subiaco WA Dr Thomas Van Hagen Active
Fiona Stanley Hospital WA Dr David Ransom Active
Royal Hobart Hospital TAS Dr Louise Wigston (nee Nott) Active
Auckland City Hospital NZ Dr Ben Lawrence Not yet activated
Christchurch Hospital NZ Dr Dean Harris Not yet activated

 

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