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: Jenna Mitchell
Contact Email: firstname.lastname@example.org
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 â‰¥ 55%), primary site (pancreatic vs non-pancreatic) and FDG-PET uptake and/or avidity (<10 v >10). The sample size is 70.
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