I am really enjoying feeling well and being home, although lately I’ve been preoccupied with planning again – for the next Brisbane trip when I have my operation to reverse the ileostomy (2nd July).
I am thinking I will sign up for the Pazopanib trial and here at last I’ve written something about it:
Fast-growing cancer needs to be fed with a really good blood supply. An aggressive tumour organises this itself by releasing a chemical factor towards the nearest passing artery, causing it to make a new blood vessel to connect with the tumour. This is angiogenesis. The anti-angiogenesis drug Pazopanib blocks the chemical factor, or reception of it, preventing the new blood vessel growth so the new tumour starves.
The first generation of this drug is Avastin (administered by IV) which I think has been thoroughly tested and approved in the US for treatment of renal cancer (kidneys). It has been tested for all sorts of cancers and the biggest response was for renal cancer so it was quickest to get approval for that.
Pazopanib is a 2nd generation drug and has been through Phase 1 and 2 testing for ovarian cancer which means now it’s time to test it on a much wider group of women to gather more data on its performance. For the ethics committee to approve this Phase 3 trial they would have to have been convinced that there is good evidence that it may prevent cancers growing (or in the worst case do nothing to the cancer).
Pazopanib comes as a tablet to be taken daily at home. The trial is to monitor 900 women across 14 countries taking the drug for 12 months. The trial is double-blind, so 50% of the women take a placebo and neither they nor the doctor knows who. The trial continues for about 4 more years. After that it could be more years before the TGA approves the drug for general use in Australia and even then it might be very expensive and not offered to public patients. At the end of the 12 months there is a chance the specialist may authorise that his patients continue on Pazopanib if the benefits are already proven. This would be a maintenance treatment in future, with people like me taking the drug for life. All the medical people I’ve consulted emphasise that this trial is my best chance to benefit from this promising new treatment of the future.
There are long lists of possible side effects, most of them pretty rare, but the 3 main ones they told me to think about are:
1 fatigue – I might be lucky since I didn’t suffer much with the IV & IP chemo.
2 blood pressure rise – my BP has always been excellent to low so a bit of a rise mightn’t be a problem. It is controlled with medication if it gets too high.
3 liver function problems – 1 in 100 people on this drug can have this serious side effect and they would immediately drop out of the trial. Liver function is monitored intensively to detect problems.
Anyone with heart problems wouldn’t be suitable for this treatment because they might need the ability to grow healthy new blood vessels to bypass a blockage. Otherwise, there don’t seem to be any warnings for anti-angiogenesis.
The trial is voluntary and I can drop out at any time if I can’t tolerate the side effects, or for any reason.
The pre-screening and checkup appointments are all in Brisbane with the research team (can’t be anywhere else). This involves weekly appointments for 3 weeks, 3-weekly checks for 3 months and 3-monthly checks till 12 months. I think the cost of my trips will be covered by the hospital system. I would probably start on the drug at the end of August.
Here are some pros and cons of joining in the Pazopanib trial:
1 Pazopanib may prevent tumours coming back. On the trial I’d have a 50% chance of this advantage (otherwise placebo).
2 More thorough testing and care even if on placebo.
3 More free trips to Brisbane and potentially time with Janet.
4 Helping develop better treatment for ovarian cancer to help women in future
1 Side effects
2 Unknowns from a drug so new.
3 More time away from home.