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Brief Title: Stromal TARgeting for PAncreatic Cancer (STAR_PAC)
Official Title: A Phase 1B Study Repurposing ATRA as Stromal Targeting Agent Along With Gemcitabine and Nab-Paclitaxel for Pancreatic Cancer (STAR_PAC)
Study ID: NCT03307148
Brief Summary: Pancreatic cancer (PDAC) is the fourth highest cancer killer worldwide and is responsible for 6% of cancer deaths. Around 80% of patients are diagnosed at a late stage when cancer has spread and surgical removal is no longer possible. At present there are no treatments available which will shrink the tumour to enable surgical removal. A main factor in the lack of treatment options for patients is that pancreatic cancer is surrounded by a thick scar tissue called the stroma, which forms a barrier to prevent chemotherapy from entering and shrinking the tumour. Research carried out in laboratories has shown that a derivative of Vitamin A, All Trans Retinoic Acid (ATRA), may have the ability to break down this stroma allowing chemotherapy to reach the cancer. STAR_PAC will test the combination of ATRA with two chemotherapy drugs; Gemcitabine and Nab-Paclitaxel in patients with locally advanced or metastatic pancreatic cancer. There are two parts to the study; the first will test different doses of the drugs on around 24 patients to find the highest dose patients can take without too many side effects. The second part will test this dose on around 10 patients to find the dose that will produce the desired effect with limited side effects. Patients will take ATRA for up to 6 cycles and chemotherapy until their cancer worsens and will be followed up for 12 months. The study will also explore the ability of a type of scan, DW-MRI, to detect changes in the cancer (optional for patients). Patients can also opt to donate additional tumour samples (biopsies) and normal cell samples (cheek cells and hair samples). Eligible patients will be recruited through NHS Clinics and should have histologically confirmed locally advanced or metastatic pancreatic cancer according to RECIST criteria and must have received no prior treatment for this cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
Barts and The London NHS, St Bartholomew's Hospital, London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
Imperial College NHS Trust, London, , United Kingdom
Name: Sarah Slater, Dr
Affiliation: Barts & The London NHS Trust
Role: PRINCIPAL_INVESTIGATOR
Name: Hemant Kocher, Professor
Affiliation: Queen Mary University of London
Role: STUDY_CHAIR