A phase 1 study looking at ATRA with gemcitabine and nab-paclitaxel for people with locally advanced or metastatic pancreatic cancer (STAR_PAC)
Full title: A Phase 1B study repurposing ATRA as stromal targeting agent along with gemcitabine and nab-paclitaxel for pancreatic cancer (STAR_PAC)
Why is this study being carried out?
This phase 1 trial is for people with locally advanced and advanced (or metastatic) pancreatic cancer. Locally advanced pancreatic cancer is cancer that has started growing into organs or blood vessels around the pancreas and can’t be removed with surgery. Advanced cancer is cancer that has spread to other parts of the body. Surgery also is not an option for this type of cancer, but people with locally advanced or advanced pancreatic cancer may be offered chemotherapy to control the cancer.
Researchers think that using a tablet called ATRA (all trans retinoic acid) might help to make chemotherapy work better. The STAR_PAC trial is looking at using ATRA in combination with the chemotherapy drugs nab-paclitaxel (Abraxane®) and gemcitabine (Gemzar®). Researchers want to see if combining nab-paclitaxel and gemcitabine with ATRA can improve the effectiveness of chemotherapy treatment.
STAR_PAC is a two-part trial. Part 1 of the trial is already complete. It looked at the highest and safest dose of combining gemcitabine, nab-paclitaxel and ATRA, without causing too many side effects. Read about the main side effects of gemcitabine and nab-paclitaxel.
Researchers are now recruiting for the second part of the trial. At the start of part 2, each person taking part will get the highest dose that was found in part 1. The researchers will then do a blood test to check vitamin A levels in the bloodstream. The ATRA dose may then be increased or decreased to make sure that everyone is getting the best dose of the treatment.
If you take part in part 2 of this trial you will be given up to six cycles of ATRA and chemotherapy, with each cycle lasting 28 days. For each cycle you will be given gemcitabine and nab-paclitaxel on days, 1, 8 and 15. You will also take ATRA twice a day from days 1 to 15 of each cycle.
You may also continue taking gemcitabine and nab-paclitaxel after completing the six cycles. The trial team will discuss this with you.
Who is the trial suitable for?
The STAR_PAC trial may be suitable for you if you have:
- locally advanced or advanced (metastatic) pancreatic cancer
- a type of cancer called pancreatic ductal adenocarcinoma (PDAC) – this is the most common type of pancreatic cancer
- had no previous treatment for locally advanced or advanced pancreatic cancer - apart from chemotherapy if you ended it at least six months before starting the trial
- are well enough to do normal daily activities – the trial team will discuss this with you.
It may not be suitable for you if you:
- have had major surgery in the four weeks before starting the trial
- are not fit enough to take part in the trial – the trial centre can talk to you about this
- have had other cancers in the last five years– this does not include some forms of skin cancer or cancer that was cured and has not come back in the last five years
- have a history of allergies (including soya bean or peanut allergies), lung disease or tissue disorders such as lupus and scleroderma
- have HIV or a hepatitis B or C infection
- have a history of heart disease
- have had any vaccinations within four weeks before starting this trial
- have participated in another trial or drug treatment up to 30 days before starting this trial.
Recruitment start date for part 2 of the trial: May 2017
Recruitment end date for part 2 of the trial: March 2018
Published in August 2017
Review date: March 2018
Part 2 of the STAR_PAC trial is being carried out at:
- St Bartholomew's Hospital, London
- Addenbrooke’s Hospital, Cambridge
Trial Chairman: Prof Hemant Kocher, St Bartholomew’s Hospital
Chief Investigator: Dr David Propper, St Bartholomew’s Hospital
You can contact the trial co-ordinating centre at Queen Mary University of London Hospital.
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
Find out more about the STAR_PAC trial.
For references used to develop this information please email us.