PINBALL
Research type
Research Study
Full title
A Phase II Pilot Trial Of Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and the Addition Of Paricalcitol Upon Disease Progression in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
IRAS ID
233887
Contact name
David Propper
Contact email
Sponsor organisation
Queen Mary University London
Eudract number
2017-004467-13
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
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.
There are strict eligibility criteria for this trial. Broadly speaking, 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/gemcitabine/cisplatin) until disease progression. At that point 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.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1276
Date of REC Opinion
2 Oct 2018
REC opinion
Further Information Favourable Opinion