NCT03529175

Scheduling Nab-paclitaxel With Gemcitabine

Randomised Phase II Trial to Investigate Two Different Schedules of Nab-paclitaxel (Abraxane) Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: CCTU- Cancer Theme · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Metastatic pancreatic cancer is difficult to treat. Until recently, most patients would be offered treatment with a chemotherapy drug called gemcitabine. However, a large international trial showed that combining gemcitabine with a drug called nab-paclitaxel (or abraxane) was more effective compared with gemcitabine alone. The purpose of this study is to compare two different ways of combining gemcitabine with abraxane. Conventionally, both drugs are given on the same day via a drip into a vein in the arm but research suggests that giving abraxane 24 hours in advance of gemcitabine could possibly be more beneficial. In this study, blood and tumour samples will be collected and analysed to try to confirm what has been seen in the laboratory studies. In addition, the investigators wish to find out whether certain tumour characteristics (called biomarkers) can be used to predict for response to chemotherapy.

Conditions

• Pancreatic Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	Abraxane (nab-paclitaxel)
DRUG	Gemcitabine

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2018-05-18
• Last updated: 2019-07-16

Locations

23 sites across 1 country: United Kingdom