A trial of NUC-1031 with carboplatin for ovarian cancer that has come back (ProGem2)

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

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 1

This trial is looking at a new drug called NUC-1031 with carboplatin to treat ovarian cancer that has come back after treatment. The trial is for women who have ovarian cancer that has come back after initially responding to platinum drugs. Open a glossary item

The trial is for women who have

These cancers are treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all of these.

More about this trial

Doctors usually treat ovarian cancer with surgery followed by chemotherapy. One chemotherapy drug they often use is a platinum drug called carboplatin. If your cancer responds to this type of treatment and doesn’t get worse again for more than 6 months, it is described as being platinum sensitive.

If your cancer comes back later on, you may have carboplatin again alongside other anti cancer drugs. One such drug is the chemotherapy drug gemcitabine. But some cancer cells have, or can develop, resistance to gemcitabine. This means that gemcitabine can no longer control or shrink the cancer.

In this trial, the researchers are looking at a new drug called NUC-1031 (also called Acelarin) alongside carboplatin. NUC-1031 works in a similar way to gemcitabine. But laboratory studies Open a glossary item have shown that NUC-1031 may overcome resistance to gemcitabine.

The aims of this trial are to

  • Find the highest safe dose of NUC-1031 you can have with carboplatin
  • See how well this drug combination works

Who can enter

You may be able to join this trial if you have one of the following

And all of the following apply

  • Your cancer has come back some time after treatment with chemotherapy
  • You have already had 2 other types of chemotherapy (this can include gemcitabine)
  • Your cancer can be measured on a scan, or your CA125 blood test results can be used to measure how the cancer responds to treatment
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Your blood test results are satisfactory
  • You are willing to use reliable contraception during the trial and for at least 3 months afterwards if there is any chance you could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply

  • Your cancer has spread to your brain or spinal cord
  • You still have side effects from chemotherapy or radiotherapy unless they are mild
  • You have already had NUC-1031
  • You are allergic to gemcitabine or carboplatin
  • You have had another cancer in the last 3 years apart from basal cell carcinoma Open a glossary item
  • You have an infection that is being treated with antibiotics through a drip into a vein
  • You have HIV, hepatitis B or hepatitis C
  • You have any other medical condition or mental health problem that the trial team thinks could affect you taking part in this trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 1 trial. The trial team need between 18 and 36 women who are going to a hospital in the Imperial College Healthcare Trust to join.

The first few women taking part will have a low dose of NUC-1031 with carboplatin. If they don’t have any serious side effects, the next few women will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

You have both these drugs as a drip into a vein through a central line or a PICC line.

You have carboplatin once every 3 weeks. Each 3 week period is called a cycle of treatment. You have NUC-1031 at the beginning of the 1st and 2nd week of each cycle of treatment. As long as it is helping you and the side effects aren’t too bad, you can have up to 6 cycles of treatment.

To measure the amount of NUC-1031 in your blood, the researchers will take blood samples at regular times during and after each treatment.

They will also ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. They will use this to look for proteins or genes Open a glossary item in the cancer cells that could tell them how well your cancer may respond to NUC-1031.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These tests include

  • A physical examination
  • Blood tests
  • Tests to see how well your lungs are working (Lung function tests ) Open a glossary item
  • Heart trace (ECG Open a glossary item)
  • CT scan
  • PET-CT scan (if needed)

Before starting treatment, you go to the hospital to have a central line or PICC line put in.

During treatment, you see the doctor every 3 weeks for a physical examination and blood tests. You go to the hospital at the beginning of the 1st and 2nd week of every 3 weeks for treatment. You have a CT scan at weeks 9 and 18.

You see the trial doctor 3 weeks after you finish treatment and have a physical examination, blood tests and a heart trace. Your doctor will tell you how often they want to see you after that.

Side effects

NUC-1031 is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include

NUC-1031 is similar to gemcitabine and the researchers expect there to be similar side effects. We have information on the side effects of gemcitabine.

We also have information about the side effects of carboplatin.

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 Sarah Blagden

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Imperial College Healthcare NHS Trust
NuCana Biomed Ltd

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12585

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.”

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