Waiting for the call

I'm optimistic I'll be accepted into the clinical trial and am therefore posting its details today. If I weren't (mostly) confident this was going to be my future, I'd be wasting my (and your) time. But I expect the phone call tomorrow, so here goes.

As I mentioned in previous blogs, the study's purpose is to study the effects of Regorafinib (or BAY 73-4506). Specifically to answer:

1. How do Regorafinib and other drugs interact to affect the clearance of the medication from the blood?
2. How much of the probe substates (the other drugs) remain in the blood after co-administration?
3. Does Regorafinib cause tumour shrinkage (previous studies have proven yes, but it's a good purpose to have again)?
4. What are the side effects of Regorafinib (again, studied before but good to examine again)?

The group to which I'm assigned determines the other drugs I'll get.

Group A will receive:

• Warfarin (Coumadin), a blood thinner
• Omeprazol (Losec), an antacid (which I've taken before)
• Midazolam (Versed), a sedative that's used to treat insomnia, seizures and as a sedative

Because Warfarin thins the blood, group A participants will also receive vitamin K, whch counteracts the drug's effects and thickens the blood.

Group B will recieve:

• Rosiglitazone (Avandia), a diabetic medication

Health Canada has issued a warning about Avandia, stating it may increase the risk of serious heart problems, including heart failure, angina (chest pain), heart attack and fluid retention. But thousands, if not millions of people have taken this drug. With only two doses, my risk of these side effects is extremely low.

You can see now why I would like group B. You can tell when you're blood sugar is dropping and eat something. You can't feel your blood thinning. I know the researchers will watch me extremely carefully, but group A also requires more blood tests during the study, which will make it a bit more difficult to plan my life.

The study

Before the Regorafinib
This will be an eight to 10 hour day at the cancer centre. It will start with a physical exam, ECG, blood tests and a urine sample. Then I'll be given the assigned drugs by themselves to assess my body's reactions. I'll have blood drawn at 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours. Then I need to come back the next two days for a 24 and 48 hour blood draw. If I'm in group A, I'll skip a day and then go back for two more days for a 96 and 120 hour blood draw.

All this must be done in Hamilton, so it involves three days, plus two more days of appointments for group A. If I'm in that group, they'll also examine my blood to ensure it's clotting properly and if not, give me vitamin K to counteract the Coumadin's effects. I'm assuming that will mean extra time in the cancer centre.

Regorafinib
A week after taking the assigned drugs, I'll attend an appointment to get the Regorafinib. This appointment will once again involve a physical exam and ECG. Then I'll get the drug - four tables a day - to take 30 minutes after a low-fat breakfast (yeah, no fasting). Then I'll go home and take the drug for two weeks before returning to the cancer centre.

The mixing of medicine
On day 14 (or three weeks after this entire thing starts), I'll spend another eight to 10 hour day at the cancer centre. I'll start with all the monitoring tests and exams, then I'll take the assigned drugs with the Regorafinib in my system. Again, I'll hang around and they'll take my blood 0.5, 1, 2, 4, 6 and 8 hours after consuming the drugs. This is the key segment of the study, where the researchers will see how the drugs interact in an individual.

Then I'll return the next two days for follow-up bloodworks and if I'm group A, I'll skip a day and then return to Hamilton for two more days of blood draws. (That's another reason I'm wishing for group B; to reduce the number of treks down the 401.)

After the big experiment, I'll simply taking the Regorafinib until:

• It stops being beneficial
• The side effects aren't tolerable
• The study is discontinued

I'll need to have my blood tested weekly for awhile to ensure my liver function isn't affected, which is a risk of the Regoranfinib, but my nurse said I can do those in London. At that point, I'll only have to go to Hamilton on days 1 and 21 of the 28 day cycle. Oh yeah, I'll take the Regorafinib for 21 days and then have a week off.

So after the first and fourth week after my start date, the trips to Hamilton will decrease. Of course, that's if all goes well, which of course, it will. (Do you like my optimism?)

I'm quietly - and internally - excited about this clinical trial. Quite honestly, I was too tired, sore and stupidly busy at work to generate too much enthusiasm today. I'm sure once I get the confirming phone call and figure out the logistics of the timing, I'll feel more excitement (and nervousness).

I'll need a colour-coded calendar to keep track of all my trips to Hamilton, but at least I'll have appointments. And it won't mean chemo.

The details are complicated and they're subject to change. I probably have one or two things incorrect too, but you get the general gist.

I'm crossing my fingers I get the phone call tomorrow . . .

Tina