A trial looking at dasatinib and gemcitabine for locally advanced cancer of the pancreas (CA180-375)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Pancreatic cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at using a new drug called dasatinib with gemcitabine for pancreatic cancer that has spread into the surrounding tissue (locally advanced Open a glossary item ).

More about this trial

Doctors often treat locally advanced pancreatic cancer with gemcitabine. They may follow this with radiotherapy.

Dasatinib is a biological therapy called a tyrosine kinase inhibitor (TKI). TKIs block tyrosine kinase which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

The researchers want to find out

How well dasatinib and gemcitabine work together for locally advanced cancer of the pancreas
How safe this combination is

Who can enter

You may be able to enter this trial if you

Have adenocarcinoma of the pancreas that cannot be removed with surgery
Have satisfactory blood test results
Are well enough to carry out all your normal activities apart from heavy physical work (performance status 0,1)
Are willing to use reliable contraception during treatment and for 3 months after if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have pancreatic cancer that has spread to another part of your body
Can have surgery to remove your cancer
Have already had treatment for pancreatic cancer
Have already had gemcitabine or dasatinib
Have had moderate to severe symptoms in the last 6 months caused by fluid on the lung (pleural effusion), such as shortness of breath
Have had a serious heart problem in the last 6 months, such as a heart attack or problem with the rhythm of your heart
Have a significant problem with bleeding or how your blood clots
Have another cancer
Have an infection
Have high blood pressure that is not controlled by medication
Have had another experimental drug in the last month
Are taking medication that strongly affects the CYP3A4 enzyme – your doctor can advise about this
Have any other medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit up to 200 people from around the world.

It is a randomised trial. You will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in. Neither you nor your doctor will know which group you are in. This is called a double blind trial.

The 2 treatment groups are

Gemcitabine and dasatinib
Gemcitabine and a dummy drug (placebo)

You have gemcitabine as a drip into a vein. You have it once a week for 3 out of every 4 weeks. Each 4 week period is called a cycle of treatment.

Dasatinib and the dummy drug are tablets. You take the tablets at the same time each day.

After 6 cycles of treatment, your doctor will talk to you about whether you need to have radiotherapy. If you have radiotherapy, you will stop having gemcitabine and dasatinib, or the dummy drug. You can start them again after you have finished your radiotherapy.

You can continue to have gemcitabine and dasatinib, or the dummy drug, as long as the side effects aren’t bad and the treatment is still helping.

Hospital visits

You will see the doctor and have some tests before starting treatment. These tests may include

A physical examination including measuring your blood pressure, temperature and pulse
Blood tests
Urine test
Heart trace – ECG
CT scan or MRI scan

At the start of each cycle of treatment you see the doctor for a physical examination and to see how you are. Every week during treatment you have blood tests. Your blood pressure, temperature and pulse are also measured. After every 2 cycles of treatment you have a CT scan or MRI scan.

If you are having radiotherapy, you will see the doctor at the end of cycle 6 for blood tests and a physical examination, including measuring your blood pressure, temperature and pulse. They will also ask you about how you have been and side effects you might have.

At the end of treatment you see the doctor and have

A physical examination
Blood tests
CT scan or MRI scan

Your doctor will talk to you about any other visits that may be needed.

Every month after treatment your doctor will see you, or the study team will phone you, to see how you are.

Side effects

The most common side effects of dasatinib include

A drop in blood cells causing an increased risk of infection, bruising or bleeding
Feeling or being sick
Diarrhoea
Tummy (abdominal) pain
Headache
Tiredness
Swelling of face, arms, legs or feet due too much fluid in the body
Rash
Shortness of breath
Muscle or bone pain
Cough
Chest pain

The most common side effects of gemcitabine are

A drop in blood cells
Hair loss
Feeling or being sick
Rash or itching
Weight loss
Diarrhoea
Sleepiness or difficulty sleeping
Dizziness
Shortness of breath
Joint pain

We have more information about dasatinib and gemcitabine in our cancer drugs section.

Recruitment start:

26/08/2011

Recruitment end:

15/11/2012

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Professor Jeff Evans

Supported by

Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Otsuka Pharmaceutical Development & Commercialization Inc

Freephone 0808 800 4040

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