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Ovarian Cancer

Clinical trials for ovarian cancer

Research into new ways of treating ovarian cancer is going on all the time. All drugs used to treat ovarian cancer have been evaluated in clinical trials. If early research suggests that a new treatment might be better than the standard treatment, cancer doctors will compare it with the most effective standard ones in clinical trials. These 'randomised clinical trials' are the only reliable way of testing a new treatment.

One woman we talked to was invited to go on a trial comparing different combinations of carboplatin and paclitaxel (Taxol) chemotherapy treatments before and after surgery to remove the cancer (tumour) and affected organs. She took time to consider the invitation before accepting, and explained that she did so mainly to help improve treatments for future patients.

 

Was invited into a clinical trial and describes her decision to take part.

Was invited into a clinical trial and describes her decision to take part.

Age at interview: 49
Sex: Female
Age at diagnosis: 48
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But for the trial they wanted to see which drug affected the different tumours the best and whether all women would need both drugs or whether some women could just have one drug and therefore have less toxic chemicals put into them.

So, my routine was going to be that I would have 3 cycles of Taxol, then they would do debulking surgery. Then I would have 3 cycles of Taxol mixed with carboplatin. And then finally I would have 3 cycles just of carboplatin.  

As I explained to you, it was all offered at the same time as I got the diagnosis, which was quite difficult. But we didn't agree to it that day, we took the information away and thought about it and I asked a lot of questions about it. About how it would affect me. At one point I wished I hadn't done it because I thought that I would have finished the chemotherapy quicker 'cos this was 9 cycles as opposed to 6, but the oncologist said given my condition she would probably give me nine anyway. And so, you know, it's good to go on a trial and to help other people. That's really what I wanted to do but that's why I did do it but they didn't pressurise me, they were fine. But it was there and you could do it or not do it and it wouldn't affect you either way.

This trial has now been completed and as a result of the study a combination of using carboplatin and paclitaxel in ovarian cancer is now considered standard treatment.

When asked how she felt about her treatment being selected by computer, one woman explained that she had been so ill that she would have accepted any treatment that made her feel better. Another woman who took part in a trial was pleased to discover later that she had been allocated the treatment her hospital would have used anyway. Another woman who wanted the new drug but got the standard treatment considered this 'unfortunate' but recognised it was the only fair way to conduct a trial.

 

Was happy that her treatment in a clinical trial was the hospital's standard treatment.

Was happy that her treatment in a clinical trial was the hospital's standard treatment.

Age at interview: 33
Sex: Female
Age at diagnosis: 30
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Another thing that you mentioned was that you took part in that trial, so the computer I assume chose which treatment you were going to have.

I would presume, yeah.

How did you feel about that, not being in actual control yourself of which treatment you had?

I was kind of told by the doctors and nurses that both of them were fine. I think at that point when I agreed to go on the trial I didn't perhaps know that Taxol carboplatin at that time was the gold standard, which I would have been offered if I hadn't gone on the trial. I would have been offered it anyway, which I know not every hospital does that. Maybe it does now because there was new Government kind of introductions to treatments of ovarian cancer. But I would have been offered it at my hospital so therefore post, I was delighted at reading 'oh I'm on that one, great'.

I don't know how I would have felt if the other one had been chosen and I found that I wasn't on the gold standard treatment, I don't think I would have been quite as happy, perhaps.

Several women had been invited to take part in a trial comparing carboplatin alone with the combination of carboplatin + paclitaxel (Taxol). Paclitaxel can cause worse side effects than carboplatin and always causes hair loss. Some women declined the offer because they did not want to risk getting the combination treatment with its worse side effects or because it might have involved extra hospital visits. One woman did not take part in a trial comparing cisplatin and carboplatin because she wanted her oncologist to choose the optimum treatment for her.

 

Decided against going in a clinical trial because she wanted to avoid the severe side effects of...

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Decided against going in a clinical trial because she wanted to avoid the severe side effects of...

Age at interview: 65
Sex: Female
Age at diagnosis: 59
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And then I had, six months' chemotherapy, Platinum, I had. I could have had the - I can't remember what it's called, the one that comes from the yew tree - but it was a trial, and it was only hit and miss whether you got it or not, and there's a lot of very bad side effects with it, I can't remember what it's called now.

Is it Taxol?

Yes. Taxol, that's it. And I had had alopecia before and I really didn't want to lose my hair, I mean, you know, you get stupid things you think about. You know, does it matter whether you lose your hair or not? But I didn't want the side effects, so I said I'd just have the Platinum.

I think that Taxol was fairly new then, and they offered me a chance to go into the clinical trial and, but they pick you, I know they pick you out of a hat so you're either on it or you're not. And and, explained all the side effects to me and I felt I couldn't cope with them at that moment. And the carbo' whatever it's called, is, had less side effects, which is what you get anyway if you weren't picked out of the hat, so I said 'I don't want to go on it'. They gave me time to think about it, and I said 'no I don't want it'.
 

The decision about whether or not to take part in research should be made without pressure and without any effect on the medical care the person receives. However, sometimes this had to be decided soon after diagnosis, when a woman and her family have hardly had time to take it in. A woman who had been a nurse had felt uncomfortable about her decision not to take part in a trial, since she knew that the doctors would have liked her to agree.

 

Felt uncomfortable about her decision not to take part in a clinical trial.

Felt uncomfortable about her decision not to take part in a clinical trial.

Age at interview: 48
Sex: Female
Age at diagnosis: 41
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And I did feel uncomfortable about turning down the offer of going on a trial. And maybe it was very selfish because a lot of people have said to me 'Well people have got to go on these trials because otherwise, you know, there's no benefit to others.' And I know that's true but at the time I had to think about myself and my family, and one of the things my son had said at the time was 'Whatever you do mum don't lose your hair,' and I just felt it, I don't think it's always taken on board that there are a lot of issues about how you're perceived that might be affected by the treatment. And for me that was just one of the issues really.

So were you able to discuss with your consultants about which drugs to have so that you wouldn't lose your hair?

With the carboplatin I didn't lose my hair, but if I'd gone on the trial and I'd chosen, I'd been chosen to go on the particular arm with the combination, I would have lost my hair. But they just felt it was because of that reason, but I just felt that first of all I'd been diagnosed very early and I didn't feel it was appropriate in my particular situation to, to be having both drugs. And also I felt that if it did come back I needed to have something in reserve if it returned, so. But I had three weeks to think about it.

Women whose cancer has recurred are sometimes offered experimental drugs. In the early stages of development drugs are often investigated on their own, not compared with other drugs. A few women asked their doctors if there were any trials they could join. Some were not suitable candidates for any trial being run at that time, and one woman decided against a trial after talking it over with her GP.

 

A recurrence of her cancer was treated with new experimental chemotherapy drugs.

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A recurrence of her cancer was treated with new experimental chemotherapy drugs.

Age at interview: 62
Sex: Female
Age at diagnosis: 60
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We then tried a new drug called Iressa, from AstraZeneca, which is a growth inhibitor. I was on that for about six or seven weeks before we had to give it up. It brought the marker down again so it was working quite well, but I had a lot of side-effects, mainly diarrhoea and skin rashes. What then happened is that I started to shake violently and be sick after taking it, so we decided I couldn't tolerate the drug longer.

At the minute we've decided to try a new drug Merck are taking through trials in Switzerland. It's going to be called cetuximab, which is a growth inhibitor that works like an antibody so in theory it will be easier to tolerate. As far as we know nobody's used it for ovarian cancer before and certainly I'll be one of the first people to take it in the UK. It will cost a fortune and I'll be a guinea pig again, but let's pray that it works.  

Another trial that women were invited to join in was one to determine the best time to treat women whose tumour recurs. In this trial, called OV05, all women in remission received regular CA125 blood tests (see 'Treatment outcomes and follow up'), and if the level of the tumour marker rose patients were randomised either to be told the result and receive chemotherapy straight away or to have the result withheld and wait until their symptoms recurred or scans showed that the tumour had regrown. One woman decided this trial was not for her because she would want to know if her CA125 level was rising.

 

Describes a trial where a rise in women's CA125 prompts randomisation to further treatment or to...

Describes a trial where a rise in women's CA125 prompts randomisation to further treatment or to...

Age at interview: 62
Sex: Female
Age at diagnosis: 61
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I go back every three months for a check up. I am taking part in OVO5, which is a clinical trial. So each time I go for a check up I have a blood test taken. This is not standard treatment, the standard treatment is that when you go for a check-up they will think about testing your blood if the symptoms are returning, but being on the clinical trial I have my blood tested each time for the CA125 but neither myself nor my consultant knows what the result is, it goes to the clinical trial centre.

If my blood, my CA125, starts to go up, I will be randomly allocated to one of two groups, one of which will go onto chemotherapy straight away as soon as the tumour marker starts to rise, and the other group won't, it will just carry on with the standard treatment of waiting until the symptoms return. This is to see which group survives longest but it's also largely concerned with quality of life, to see if there is a difference.

So if you're not randomised to further chemotherapy would you be told that your tumour marker was raised or not?

No, no.

 

Refused to take part in a follow-up trial in which she would not know if her CA125 level rose.

Refused to take part in a follow-up trial in which she would not know if her CA125 level rose.

Age at interview: 41
Sex: Female
Age at diagnosis: 35
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Certainly I was asked to go on a trial later on, a follow-up trial to do with the CA125 marker, and I think the trial was basically, not telling women what the CA125 marker was.

Oh yes I've heard about that one.

And I actually refused to do that one. I thought I would be the kind of person who would not be happy not knowing what the CA125 marker was. And I mean I was, I like to help out whenever I can, the hospital in any way, and I would be quite keen to do it, but knowing the kind of person I am, I thought no, I'm not going to be able to cope with that. I need the reassurance of my, of my count.

The OV05 trial has also now been completed and the results were published in 2010 (Lancet 2010) they showed that treating women as soon as their CA125 levels go up does not help women with ovarian cancer to live longer. Treatment can safely be delayed until it is clear that the cancer has recurred based on examination, scan results or symptoms.

A woman whose cancer recurred after her initial treatment was invited to take part in a trial in which a sample of her tumour was tested in the laboratory to find out which drug combinations it would respond to, but she wanted to know the test results and used her medical insurance to find out. 

 

Used her medical insurance to find out the results of tests taken as part of a clinical trial.

Used her medical insurance to find out the results of tests taken as part of a clinical trial.

Age at interview: 57
Sex: Female
Age at diagnosis: 52
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So we looked at another trial, but this time the trial was taking a sample and testing it in the laboratory to see which of the chemotherapies affected it. So we did that but I couldn't cope mentally with not knowing the results, and therefore I had to, we used our medical insurance to actually find out the results so that I could see what my cancer reacted to and which one I was going to have. So I had a combination drug and in fact that suited me really, really well.  

Because in the laboratory they offered to take, the laboratory test offered to take a piece of the tumour and to see what would affect it, and I wouldn't have that, you know, I said to my surgeon I said 'I do not want a knife to go into the tumour' so I waited until I got some ascites and then a very nice man who normally does the antenatal ladies and does the amniocentesis, he used his long needle to take out some of the ascites from that and that was sent away and I had great faith in that. I just didn't want the tumour cut, mentally I couldn't cope with that. 

So when it was sent away to the laboratory it came back and it doesn't say 'this will work', it says 'this might be helpful' and one of the combinations, which was the first one they tried on me, was gemcitabine and treosulfan, and that's the one that I had for fourteen lots every other week.

People who take part in trials appear to do better. This may be a result of the extra attention and careful monitoring they receive or because the types of patients who are eligible to enter trials would do better anyway. One woman mentioned that the only way she could have a new chemotherapy was by being in a trial. Another commented that being in a trial meant she had more regular check-ups. 

 

Had more regular check-ups because she was taking part in a trial.

Had more regular check-ups because she was taking part in a trial.

Age at interview: 33
Sex: Female
Age at diagnosis: 30
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I didn't, I felt involved to a degree in treatment plans but because I agreed to go on this trial, and I think I agreed to go on the trial because it's a case of it's good for future, but I also agreed to go on it because I was kind of told that you tend to get good treatments if you go on trials because the drug companies are actually paying for it. I was kind of told that as well. So I just kind of, you know, I wasn't, I was almost prepared I suppose, to put my life in their hands.  

My follow-up appointments are quite specific for five years because I was on a trial, and for the first two years I got follow-ups every two months, the third year every three months, and now into my fourth year so it's every four months, and from about six months time it will then be six monthly. But I have been told that if I hadn't been on a trial it would have been six-monthly now already, so I'm quite pleased I was on the trial because I'm getting regular check-ups.

For more information on current ovarian cancer trials see: Cancer Research UK and Ovacome who have lists on their websites.
 

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Last reviewed June 2016.
Last updated June 2016.

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