The Addition of Nab-paclitaxel (Abraxane) to First Line Treatment of Metastasized Oesophagogastric Carcinoma (ACTION)
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
Oesophagogastric cancer is a major cause of cancer related mortality, with an overall 5-year
survival rate of 10% worldwide and patients are often diagnosed with locally advanced or
metastasized disease at first presentation. For advanced oesophagogastric cancer
fluoropyrimidines are the backbone of palliative chemotherapy and is commonly used in 2- or
3-drug combinations .
However, in clinical practice after progression on first line therapy, a substantial number
of oesophagogastric cancer patients may not be able to start second line chemotherapy due to
rapid clinical deterioration. Therefore, new triplets with high anti-tumor activity and low
toxicity are urgently needed.
Given the activity of capecitabine and oxaliplatin containing regimens and the potential of
taxanes in oesophagogastric cancer, the investigators propose a phase I study combining
capecitabine and oxaliplatin with Nab-paclitaxel.
Solvent-based taxanes (paclitaxel, docetaxel) can cause severe toxicities not only by the
active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane) is a
solvent-free formulation of paclitaxel encapsulated in albumin. It does not require
premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated
hypersensitivity reactions. This new formulation improves safety profile, allows higher
dosing with shorter infusion duration, and produces higher tumor drug concentration. It has
proven activity in breast cancer, non small lung cancer and pancreatic cancer, as well as in
gastric cancer models.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)