VanSel Phase 1 clinical drug trial

Now we know that Steve is definitely taking part in this Phase 1 study, I thought it might interest you to know a bit more about it.  If you want to know more about clinical drug trials and the difference between phase 1 and later phase trials click here, this link with take you to the Cancer research UK website where it's explained very clearly .

The purpose of the biological therapy trial is to determine whether using two drugs, vandetanib and selumetinib, in combination is effective in the treatment of cancer.  

• Vandetanib is a VEGFR (Vascular Endothelial Growth Factor Receptor) and EGFR (Epidermal Growth Factor Receptor) inhibitor; VEGF is a substance made by cells which helps new blood vesssels develop and grow. VEGR inhibitors stop cancers developing the blood vessels that they need to grow
• Selumetinib is a MEK (Mitogen Activated Kinase) inhibitor which blocks the pathway along which signals are sent to cells telling them to divide and grow

Although these types of drugs have shown to have an effect in non small cell lung cancer (NSCLC), this is the first time the drugs have been used together.  The aim is to see if combining these drugs has an increased anti-tumour effect for patients whose treatment options are limited.

Steve will be participating in the first part of this study which is for patients with any solid tumour.  The second part of this study is only for patients with non small cell lung cancer. 

The four main aims of this clinical study are to find out:

• If the two drugs can be given safely to patients when given together
• The maximum dose that can be given safely to patients
• More about the potential side effects of the drugs and how they can be managed
• What happens to vandetanib and selumetinib inside the body

The first part of the trial is a "dose escalation" study.  In this phase, 9-24 patients will receive vandetanib and a low dose of selumetinib to establish a safe dose to recommend for the next stage of the study.  If they don’t have any serious side effects, the next cohort of patients will have a higher dose of selumetinib, and so on, until they find the best dose to give. 

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.  

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!

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