Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Unicentric, Open Label, Mechanism of Action Trial, on the Biological Effect of Nab-paclitaxel Combined to Gemcitabine, in Patients With Metastatic Pancreatic Adenocarcinoma
The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold
standard since the end of the 90s' is gemcitabine; unfortunately all trials testing
combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to
demonstrate any superiority over gemcitabine monotherapy.
In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel
in patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an
impressive response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week
for 3 weeks, every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy,
nausea, haematological side effects). This efficacy can be related to an improvement of
gemcitabine delivery to the tumor bed, as shown on preclinical studies: the response rate in
xenografts was better with the combination; this improvement was associated with an increase
of intratumoral gemcitabine concentration in mice receiving the combination when compared to
mice receiving gemcitabine alone. This might be associated to modifications of peritumoral
stroma with reduction of stromal content and increase in dilated vessels.
The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine
induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor
and of liver metastases after 2 cycles of treatment by comparison to baseline.
n/a
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