Stromal TARgeting for PAncreatic Cancer (STAR_PAC)

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

DRUG

ATRA

Administered orally on D1-15 of each 28 day cycle.

DRUG

Gemcitabine

Intravenous Infusion on D1,8 and 15 of each 28 day cycle.

DRUG

Nab-paclitaxel

Intravenous Infusion on D1,8 and 15 of each 28 day cycle.

Sponsors & Collaborators

• Medical Research Council

  collaborator OTHER_GOV

• Celgene Corporation

  collaborator INDUSTRY

• Cancer Research UK Cambridge Institute

  collaborator OTHER

• King's College London

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Institute of Cancer Research, United Kingdom

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Barts & The London NHS Trust

  lead OTHER

Principal Investigators

• Sarah Slater, Dr · Barts & The London NHS Trust

• Hemant Kocher, Professor · Queen Mary University of London

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-15

Primary Completion

2019-03-19

Completion

2019-03-19

Countries

• United Kingdom

Study Locations