Pancreatic Cancer Clinical Trial
Official title:
A Phase II Pilot Trial Of Paclitaxel Protein Bound and Gemcitabine Based Chemotherapy and the Addition Of Paricalcitol Upon Attainment of Stable or Progressive Disease in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
This is a phase II pilot trial of Paclitaxel Protein Bound and Gemcitabine based chemotherapy and the addition of Paricalcitol upon attainment of stable or progressive disease in eligible patients with untreated metastatic pancreatic ductal adenocarcinoma.
Pancreatic cancer is the fourth-highest cancer killer worldwide with an overall 5 year
survival of about 8%. The only potentially curative procedure, surgical excision, is feasible
in a minority of patients, but even in these patients the majority (~80%) die within 5 years.
This study aims to see if adding paricalcitol (a vitamin D analogue) to chemotherapy can slow
down tumour growth in patients with previously untreated metastatic pancreatic cancer.
Studies have shown vitamin D can change the pancreatic tumour microenvironment from an
immunologically suppressive (tumour growth promoting) to an immunologically hostile one,
slowing down tumour growth in this way.
Patients with pancreatic cancer that has spread to other organs and who have adequate hepatic
and renal function are eligible. Participants will receive chemotherapy (paclitaxel and
gemcitabine, with or without cisplatin). On development of stable disease or disease
progression, paricalcitol will be added to the chemotherapy regimen and participants will
continue on this treatment until their cancer stops responding to treatment. After that
participants will be followed up 3 monthly for the collection of disease status and survival
data.
Participants will be asked to donate tumour and blood samples to allow the research team to
look at the effects on the tumour biology.
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