A study of veliparib with carboplatin and paclitaxel for ovarian cancer that has spread

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 3

This study is for people with newly diagnosed ovarian, fallopian or peritoneal cancer that has spread locally or elsewhere in the body. 

Doctors treat these cancers in a similar way. When we use the term ovarian cancer in this summary, we are referring to all 3. Researchers are looking for ways to improve treatment for these cancers. In this study doctors are using a drug called veliparib with chemotherapy Open a glossary item.

More about this trial

Doctors use surgery Open a glossary item and chemotherapy to treat ovarian cancer. They often use the chemotherapy drugs carboplatin or carboplatin with paclitaxel for newly diagnosed ovarian cancer. This can be used either

  • After surgery
  • Before and after surgery

Veliparib is a type of biological therapy. It stops a protein called PARP (Poly-(ADP-ribose)-polymerase) from working (it is a PARP inhibitor). This protein is important for cells to repair their DNA Open a glossary item, particularly in cells that have a change (fault or mutation) to the BRCA1 or BRCA2 genes. So if researchers can block this protein, they hope that cancer cells won't be able to repair themselves and will die.  

The aims of this study are to see

  • If the combination of carboplatin, paclitaxel and veliparib works better than carboplatin and paclitaxel treatment alone. 
  • If giving continued treatment (maintenance therapy) with veliparib slows the re growth of the cancer.
  • Why some women benefit from the treatment or have side effects.  

Who can enter

The following 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 been diagnosed with one of the following

And

  • Have a cancer that is a high grade Open a glossary item serous Open a glossary item adenocarcinoma Open a glossary item
  • Have cancer that has spread to tissues in the area between your hip bones (pelvis), tummy (abdomen) or to other parts of your body (stage 3 or 4)
  • Are willing to be tested for BRCA gene and there is a sample of tissue available that the team can test and use
  • Had surgery to reduce the size of your tumour between 1 to 12 weeks ago or will have surgery after chemotherapy and your diagnosis was confirmed with a core needle biopsy Open a glossary item
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood results
  • Are able to swallow tablets and keep food and drink down
  • Are willing to use reliable contraception before starting the study and until you have surgery if there is any chance you could become pregnant
  • Are 18 or older

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

  • Have a low grade serous Open a glossary item adenocarcinoma Open a glossary item, any other type of epithelial ovarian cancer or any other rare type of ovarian cancer
  • Have cancer of the womb (endometrium) at the same time as ovarian cancer
  • Had womb cancer in the past, unless it was early stage and no lymph nodes Open a glossary item were affected
  • Had any other type of cancer, apart from non-melanoma skin cancer, in the past 3 years.
  • Had previous radiotherapy Open a glossary item to any part of your tummy (abdomen) or the area between your hip bones (pelvis)
  • Had previous chemotherapy Open a glossary item for a cancer in your tummy (abdomen) or the area between your hip bones (pelvis)
  • Have or have had any illness or cancer of the central nervous system (CNS) Open a glossary item
  • Have had fits (seizures) in the last 12 months
  • Have active hepatitis B or C and changes in the way your liver works
  • Have congestive heart failure, angina that is not controlled by medication, certain problems with the rhythm of your heart or had a heart attack in the past 6 months
  • Have high blood pressure that is not controlled
  • Have a bowel obstruction Open a glossary item or an obstruction from your stomach into your bowel (gastric outlet obstruction)
  • Have an infection that needs IV (intravenous Open a glossary item) antibiotics
  • Have moderate or severe numbness and tingling in your hands or feet (neuropathy). If you have mild neuropathy you may be able to take part
  • Have any other serious illness or mental health problem that the study team think could affect you taking part
  • Have an allergy to paclitaxel, carboplatin or certain dyes (colourants) used in the medicine of this study
  • Are pregnant or breastfeeding
  • Are not suitable to get veliparib or the combination with paclitaxel and carboplatin in the opinion of the study team

Trial design

This is an international phase 3 study. The researchers need up to 60 people in the UK to take part. 

It is a randomised study. This means a computer puts the people taking part into 3 treatment groups. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. Your doctor may call this a double blind study.

  • You take veliparib or a dummy drug as a tablet by mouth
  • You have carboplatin and paclitaxel through a drip into a vein once every 3 weeks

You may hear doctors call this 3 week period a cycle of treatment. Your doctor may decide to give paclitaxel every week instead of every 3 weeks.

You will be in 1 of the following groups

  • Veliparib with carboplatin and paclitaxel for 6 cycles followed by veliparib for an additional 30 cycles
  • Veliparib with carboplatin and paclitaxel for 6 cycles followed by dummy drug (placebo) for an additional 30 cycles
  • Dummy drug (placebo) with carboplatin and paclitaxel for 6 cycles followed by dummy drug (placebo) for an additional 30 cycles

Study Diagram

On the 1st day of cycle 1 you have

  • Veliparib or a dummy drug as a tablet
  • Paclitaxel over 3 hours and carboplatin over 30 minutes 

You continue to take veliparib or a dummy drug twice a day for 21 days when you go home. You do this until you have chemotherapy again.

Once you have had 6 cycles of chemotherapy, you continue on veliparib or a dummy drug twice a day for 30 cycles (about 22 months).

You may have surgery before you start the study or between the 3rd and 4th cycle. If you have it during chemotherapy, you will need time to recover. This will make the time you have treatment longer. Your doctor will discuss this with you in more detail.

The study team will ask you to fill out questionnaires

  • Before you start treatment
  • Every 6 weeks during treatment
  • After you finish treatment 

The questionnaires will ask you about side effects and how you’ve been feeling. This is called a quality of life study.

Blood and tissue samples

If you agree to take part in this study, the researchers will ask for a sample of your cancer. They take this from the cancer that the surgeon removed during surgery or when you had a biopsy. The researchers want to find out why some people benefit from veliparib and others don’t. 

The researchers will also ask you for a further optional blood and tissue sample. This is separate from the blood and tissue samples for the main study. It is part of a genetic sub-study where doctors look at your genes Open a glossary item

You give the blood sample for the sub-study on cycle 1 day 1 before you start treatment. The study team will take the tissue sample from you once you have finished all treatment after 36 cycles. You don’t have to give these samples if you don’t want to. You can still take part in the main study.  

Hospital visits

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

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood tests
  • Urine test
  • Chest X-ray
  • CT scan or MRI scan

You go to the hospital every 3 weeks for your chemotherapy treatment. You should  not need to stay overnight. You see the study doctors on these days. After the first 6 cycles you see the study doctors every 6 weeks. During all of these visits you will have a physical examination and blood tests.

You have extra hospital visits between cycles to check your bloods and to have either a CT or MRI scan. You have a scan and blood tests to see how you are doing. You have them

  • Every 9 weeks
  • At the end of cycle 6
  • Then every 12 weeks for 2 years
  • Then every 6 months for 3 years
  • Then yearly

Once you have finished treatment, your doctor will see you again after about a month. 

If your cancer gets worse while you are on the study you stop treatment and your doctor will discuss other treatment options with you.

The study doctors will see how you’re doing by checking your medical records or sometimes by calling either you or your GP. They will do this every 3 months for up to 10 years. 

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.

The most common side effects of paclitaxel are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • An allergic reaction to the drug which may cause skin rash and itching, a high temperature (fever), shivering, dizziness, a headache or breathlessness
  • Numbness and tingling in your hands and feet (peripheral neuropathy Open a glossary item)
  • Feeling or being sick
  • Sore mouth
  • Inflammation around the drip site – if you notice any signs of redness, swelling or leaking at your drip site, tell your chemotherapy nurse immediately
  • Diarrhoea
  • Hair loss
  • Pain or aching in your joints or muscles
  • Low blood pressure

The most common side effects of carboplatin are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Feeling or being sick
  • Tiredness and weakness (fatigue) during and after treatment
  • Skin rash

The most common side effects of veliparib are

We have more information on Paclitaxel and carboplatin (PC, CarboTaxol)

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 Shibani Nicum

Supported by

AbbVie
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13671

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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