Phase II Trial of the Effect of Gemcitabine With Intravenous Omega-3 Fish Oil Infusion in Patients With Unresectable Pancreatic Adenocarcinoma
Our trial will involve recruiting patients who have unresectable pancreatic cancer and who
are suitable for the current standard of care which is gemcitabine chemotherapy. They will
be assessed for suitability and then offered entry into the trial. This essentially
consists of a 4 hour long infusion of purified omega-3 fish oil immediately after their
gemcitabine chemotherapy has finished. This will occur once a week for three weeks, with a
rest on the fourth week. The cycle then continues until the cancer has shown progression on
a CT scan, the gemcitabine chemotherapy is stopped due to toxicity or the patient withdraws
or dies. CT scans to assess this are performed every 2 months. Blood tests will be taken
before and after each treatment and analysed for changes in inflammatory markers. The
patients will be asked to fill in a quality of life and pain questionnaire each week during
the 4 hour infusion.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete and partial response) on CT according to RECIST criteria
Every 2 months
No
Ashley Dennison, MD FRCS
Principal Investigator
University Hospitals, Leicester
United Kingdom: Medicines and Healthcare Products Regulatory Agency
09/H0408/51
NCT01019382
October 2009
June 2014
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