Steve will be one of the first people taking part at the start of cohort "5b" which means he will take a higher dose of vandetanib than those in earlier cohorts. We have yet to find out what dose of selumetinib he will be taking, but I imagine it must be near the top end by now, as we understand that the study will finish after six cohorts.
The first cycle of treatment lasts 42 days. Vandetanib tablets are taken once a day for 14 days, starting with a high ("loading") dose for the first four days to get the drug into the system, then a lower dose (the "continuous dose") for the rest of the cycle. On day 15 you start taking selumetinib capsules each day as well as the vandetanib for the next 28 days, until the end of cycle 1.
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| Not the VanSel drugs! I will post a picture of the real thing when we have both |
There is no need for a "loading dose" of vandetanib in Cycle 2, so that lasts 28 days, taking both drugs every day. As long as you don’t have bad side effects, you can carry on taking both drugs every day for as long as the treatment continues to help you. You can also stop at any time, if disease progresses, if the side effects are too bad for you, or if you have simply had enough and want to stop.
The study started in December 2011, so the researchers have already gathered a lot of information about the two drugs and how they work. Doses are now being fine tuned to get the optimum combination.
There are a dozen or so hospital visits during cycle 1 to check on how you are doing - physical examination, blood pressure, blood samples, ECG and eye tests at different intervals - plus three occasions when bloods are taken for research over a 24 hour period, which involves hospital visits two days running (which is a bit of a pain, but avoids an overnight stay).
In cycle 2 there are weekly check ups. If you carry on to cycle 3 or beyond, check ups are monthly.
As with all drugs, there are side effects - the most common being diarrhoea, fatigue, nausea, mouth sores and skin disorders...plus swelling of the face and extremities, vomiting and fever. Less common side effects are blurred vision and changes in the electrical activity of the heart and heart rhythm (hence the eye tests and ECGs).
Hey ho! When you read a list like that, you begin to wonder if this is a good idea.....However, not everyone experiences all of these things and there is medication to help manage these side effects. Steve has managed before on his two previous treatment regimes and we are hopeful that he will be able to manage again this time round.
As before when Steve has been undergoing treatment, I will try to update the blog more frequently. If nothing else, it can be a useful record of events to refer to when faced with the usual questions by the trial team - How have you been feeling? What have you experienced? When? For how long? How intense?
You may find it a bit boring as a result....not as much fun as talking about adventures and new experiences, but just as important in its own way, especially for anyone else offered the opportunity to take part in the trial who is wondering what happens.
Life is likely to be very different for a while from next week onwards, so we will be making the most of this weekend to visit family, be sociable and enjoy some good food and wine while we can. After that it will be onwards and upwards, we hope!