A study of Acelarin with cisplatin for bile duct cancer (ABC-08 study)

Cancer type:

Bile duct cancer
Biliary tree cancers

Status:

Open

Phase:

Phase 1

This study is for people with bile duct cancer that cannot be removed by surgery or that has spread.

Researchers are looking for ways to improve treatment. In this study, doctors use a new drug called Acelarin with cisplatin chemotherapy Open a glossary item.

More about this trial

Doctors treat bile duct  cancer that has spread with 2 chemotherapy drugs, gemcitabine and cisplatin. But gemcitabine stops working in some people. The cancer cells become resistant to it.

Acelarin is a new type of chemotherapy. It is a similar drug to gemcitabine, but scientists have made changes to it to try to stop the cancer building up a resistance to the drug.

Researchers think Acelarin may work better than gemcitabine and have fewer side effects.

The aims of this study are

  • to find the best dose of Acelarin to give with cisplatin
  • learn more about the side effects and how the 2 drugs work together

Who can enter

The following bullet points list the entry conditions for this study. If you are unsure about any of these, speak with your doctor or the study team. They will be able to advise you.

You may be able to join this study if all of the following apply. You

  • Have bile duct cancer and cannot have surgery to remove it, or the cancer has come back and has spread
  • Have not had other treatment for bile duct cancer that has spread. If you had low dose chemotherapy and radiotherapy Open a glossary item after surgery, this must have been more than 6 months ago. If you have had radiotherapy for symptoms (palliative radiotherapy), this must have been more than 28 days ago and you must have an area of cancer that can be measured that is outside the radiotherapy field Open a glossary item
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Have no problems with the bile draining through your bile duct Open a glossary item
  • Have no signs of an infection in your bile duct
  • Are willing to use reliable contraception during the study and for 6 months afterwards
  • Are 18 or older

You cannot join this study if any of these apply. You

  • Have signs of cancer that has spread to your brain
  • Have not fully recovered from previous surgery or radiotherapy
  • Have had another cancer in the past 5 years or any signs of a cancer coming back, unless it is a successfully  treated non-melanoma skin cancer or carcinoma in situ of the cervix
  • Have a blockage of your bile duct
  • Have an allergy to gemcitabine or cisplatin
  • Have had treatment with Acelarin before
  • Have any signs of serious or uncontrolled illnesses elsewhere in your body 
  • Have any other serious medical condition or mental health problem that the study team think could affect you taking part
  • Have hearing loss
  • Are pregnant or breastfeeding

Trial design

This is a phase 1 study.  The researchers need up to 24 people to join.

The first 3 people taking part (called a cohort or a group) will get a lower dose of Acelarin. Researchers then see how this group gets on, so there will be a break before more people can take part in the study.  This group may be increased to 6 people depending on how the first 3 people tolerate treatment. 

After that, the next 3 people have a slightly different dose of Acelarin (this may be lower or higher depending on results from the first group of people). The researchers monitor the effect of Acelarin until they find the best dose to give. This is called dose escalation or de-escalation.

The amount of Acelarin you have depends on

  • how many people are already in the study when you start
  • what the next planned dose is

The dose of Acelarin you get will not increase during the study.

You have cisplatin through a drip into a vein and Acelarin through a central line

The first day of treatment is called day 1. You have both drugs on day 1 and day 8 every 21 days (3 weeks) if you are tolerating treatment and your blood counts are within acceptable levels.  This 3 week period is a cycle of treatment.

You have treatment for as long as you can cope with the side effects and your cancer doesn’t grow bigger.

The study team will ask you about side effects

  • before treatment on day 1 of each cycle
  • before treatment on day 8 of each cycle
  • within 30 days of the last dose of Acelarin when treatment ends

Blood samples
The researchers will ask you for 4 extra blood samples on your first day of treatment.  The researchers use these samples to see how your body processes Acelarin. 

They take blood samples

  • immediately before you get treatment
  • 30, 60 and 240 minutes after you have had Acelarin

They will also ask your consent to use these blood samples for future research.

Hospital visits

You see the study team and have some tests before you start treatment.  These include

  • Physical examination
  • Blood tests
  • CT scan

Some people may also have a kidney test using an x-ray dye to see how their kidneys work.

You go to the hospital on day 1 and day 8 of each cycle of treatment.  You see the study doctors in clinic and have treatment as an outpatient on these days if your bloods are within acceptable levels and you are well. 

During all of these visits you have a physical examination and blood tests. 

You may have extra hospital visits in-between cycles to have blood tests and to have a CT scan.  You have a CT scan

  • 3 months after your 1st day of treatment
  • then every 3 months

When you finish all your treatment, you see the doctors about 1 month later.  After this they see you in clinic every 6 weeks to check if your cancer has grown.  If it is better for you, they might be able to contact you by phone. 

Side effects

The study team will check on you during the time you have treatment.  They will give you a phone number to call if you feel worried about anything.

Possible side effects of Acelarin are

The most common side effects of cisplatin are

We have more information about

Your doctors will explain all the possible side effects with you before you start the study. 

Location

Glasgow
Liverpool
London

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Mairéad McNamara

Supported by

Experimental Cancer Medicine Centre (ECMC)
National Cancer Research Institute (NCRI)
Nucana BioMed Limited
Manchester Academic Health Science Centre Trials co-ordination unit (MAHSC-CTU)
The Christie NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12901

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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