Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Phase 1B Study Repurposing ATRA as Stromal Targeting Agent Along With Gemcitabine and Nab-Paclitaxel for Pancreatic Cancer (STAR_PAC)
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.
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