Scheduling Nab-paclitaxel With Gemcitabine (SIEGE)
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|ClinicalTrials.gov Identifier: NCT03529175|
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : July 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma Metastatic||Drug: Abraxane (nab-paclitaxel) Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Active Comparator: Concomitant
Intravenous Abraxane125 mg/m2 30-minute infusion followed immediately by intravenous Gemcitabine 1000 mg/m2 30-minute infusion will be administered on days 1, 8 and 15 of a 4-week cycle.
Drug: Abraxane (nab-paclitaxel)
Active Comparator: Sequential
Intravenous Abraxane 125 mg/m2 30-minute infusion will be administered on days 1, 8 and 15 of a 4-week cycle. Intravenous Gemcitabine 1000 mg/m2 30-minute infusion will be administered on days 2, 9 and 16 of a 4-week cycle. Gemcitabine must be delivered 24 +/- 2 hours after commencing Abraxane infusion.
Drug: Abraxane (nab-paclitaxel)
- Progression free survival [ Time Frame: From participant randomisation to the point at which disease progression is reported (i.e. 12 months) ]The primary objective of the trial is to investigate the outcome of sequential administration of nab-paclitaxel combined with gemcitabine (ABX/GEM, 24 hours apart) in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in terms of progression-free survival.
- Patient Safety [ Time Frame: 1 year after end of treatment visit ]Adverse Events (including Serious Adverse Events), abnormal laboratory test results and performance status
- Treatment Efficacy [ Time Frame: 8 weeks ]response to treatment assessed using radiological RECIST criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529175
|Principal Investigator:||Pippa Corrie||Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital|