A trial of NKTR-102 for advanced ovarian cancer that is resistant to platinum drugs

Who can enter

You can enter this trial if you

• Have ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has spread into the surrounding tissue, or to another part of the body, and cannot be removed with surgery
• Have cancer that has come back within 6 months of having platinum chemotherapy and has got worse despite then having liposomal doxorubicin (you can also join the trial if you can’t have liposomal doxorubicin for some reason)
• Have at least 1 area of cancer that can be measured and has not already been treated with radiotherapy
• 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
• Are willing to use a reliable form of contraception during the trial and for at least 8 months afterwards if there is any chance you could become pregnant
• Are female and at least 18 years old

You cannot enter this trial if you

• Have cancer that has spread to your brain or spinal cord (or your doctors suspect this may have happened)
• Have had radiotherapy or chemotherapy in the last 4 weeks (6 weeks if you had 1 of a group of drugs called nitrosoureas)
• Have not fully recovered from the side effects of earlier treatment, apart from hair loss
• Have had major surgery in the last 4 weeks or minor surgery in the last 2 weeks
• Have had biological therapy or an experimental drug in the last 4 weeks
• Have already had irinotecan, topotecan or similar drugs (the trial doctor can advise you about this)
• Have had another cancer in the last 5 years apart from non melanoma skin cancer, carcinoma in situ of the cervix or womb cancer that was stage 1A and low grade
• Are taking any drugs that can affect an enzyme called CYP3A4
• Have had a reaction to any other pegylated drugs
• Have inflammatory bowel disease, other types of bowel disease or any condition that means diarrhoea is a particular problem for you
• Have any other medical condition that the trial doctors think could affect your taking part
• Are pregnant or breastfeeding

Trial design

This international phase 2 trial will recruit about 180 women all together. About 60 of them will be at hospitals in the UK.

Everybody taking part in the trial has PEG-Irinotecan. But the researchers are giving the drug in 2 different ways.

• Women in treatment group A have it every 2 weeks
• Women in treatment group B have it every 3 weeks

You have the drug as a drip into a vein. It takes about an hour and a half each time. As long as you don’t have bad side effects, you can carry on having the trial drug for as long as it helps you.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

• Physical examination
• Blood and urine tests
• CT scan or MRI scan
• Heart trace (ECG)

During treatment, you go to hospital once every 2 or 3 weeks. You see the doctor and have blood tests. Then you have the trial drug. Each visit lasts 3 hours or more.

After you finish treatment, you go back for 1 more hospital visit. After that, a member of the trial team will contact you every 3 months to ask how you are and whether you have started any other chemotherapy.

Side effects

As PEG-Irinotecan is a new drug, there may be some side effects we don’t know about yet. From earlier trials, doctors know the side effects can include

• Diarrhoea
• Feeling or being sick
• Tiredness (fatigue)
• Loss of appetite and weight loss
• Dehydration
• A drop in the amount of potassium or magnesium in your blood
• Tummy (abdominal) pain
• Hair loss
• Blurred vision
• Constipation
• A drop in red and white blood cells causing an increased risk of infection, tiredness and breathlessness
• Headache

If you do have diarrhoea, it is very important to take the anti diarrhoea tablets that your doctor will give you and to drink plenty of water.