NCT02174887

Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer

A Unicentric, Open Label, Mechanism of Action Trial, on the Biological Effect of Nab-paclitaxel Combined to Gemcitabine, in Patients With Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel + Gemcitabine	Gemcitabine 1 g/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days in combination with Nab-paclitaxel 125 mg/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days The patients will receive 2 cycles of treatment every 28 days:

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-06-26
• Last updated: 2017-03-28

Locations

1 site across 1 country: France