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Moving forward with a clinical trial

It's been a tough couple of weeks since we got the news that Amanda's cancer returned. Amanda has had a lot of visitors to keep her mind busy, but there are still some very hard moments when the enormity of the situation is impossible to ignore.

Even with all this, we've had to consider what the next step of treatment will be. Amanda wrote this post for Facebook, and I share it again here so everyone can know what's coming up. Thanks, Amanda, for writing it!

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After researching and discussing all treatment options available to me at this point in my disease, the decision has been made to be a study participant in a clinical trial called PROCEED. This trial is being offered both in Halifax and Toronto and I have the option to start treatment here and finish it there. Only 600 women are participating around the world, and I will hopefully be one of them.

Being apart of this clinical trial is far superior than the "standard treatment", because we all know where THAT gets me. This offers a chance of a longer period of PFS (progression-free survival).

This trial involves a drug called Caelyx, the former "go-to" chemotherapy for platinum-resistant recurrent ovarian cancer, which is no longer available outside of clinical trials. The trial involves 2 groups of patients: one will receive Caelyx and a placebo, the other will receive Caelyx and the test drug (EC145). I've got twice the chance of being in the test drug group.

The test drug is a targeted chemotherapy (which means, rather than floating around killing every reproducing cell, it will target the ovarian cancer cells only, hopefully). Apparently, 80-90% of ovarian cancer cells have folate receptors (think of a receptor as a door). The test drug is a combination of a folate molecule and a very toxic chemotherapy. The belief is that once the drug gets to the cancer cells, it knocks on the "door" and because it carries folate, it will be allowed in. At that point, think trojan horse - it lets loose the chemo.

While the idea of clinical trial might sound risky, this is a good trial to be on. For one, I'm guaranteed Caelyx, a drug known to have relatively good ("relatively" is as good as it gets at this point) success with this stage of this disease. Caelyx is tolerated relatively well (it should still suck, but not as much as the first stuff I was on). There's a 2:1 chance I'll get the test drug. This is a Phase *3* trial, which means it has already gone through 2 earlier stages of study to ensure side effects are tolerated, to figure out an effective dose, and to determine that it can increase PFS (from ~2 months to ~5 months) for a lot of patients.

I will undergo a series (read: THREE DAYS) of testing next week to ensure I meet the criteria of the trial. The primary outstanding question is, do my cancer cells have folate receptors. They will determine this by injecting me with something and doing a series of nuclear images. I won't know for a few weeks if it's a go. If I'm accepted by the drug company, I should start early April.

If all goes well (i.e. my tumours do not grow or better YET, they shrink), I will be on this trial (i.e. on chemotherapy) for the next YEAR. A huge bonus would be to have a few months after that, not being on chemo, before the tumours return again, at which point a decision will have to be made to start a new chemo regimen, clinical trial or choose quality of life. However unfortunately, my doctor suspects my cancer won't respond well to chemo at all, given it came back so quickly. I'm setting out to prove her wrong.

A link to more information about the trial and a lot more sciency stuff:
http://clinicaltrials.gov/ct2/show/study/NCT01170650?term=proceed&rank=1
If you Google more, the results of the Phase 2 study can be found as well.

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Comments

  1. I will be thinking of you and following your progress. Im going to have positive thoughts and am hopeful that you will have more time than anyone thinks with your beautiful boy. Your situation is tragic, but your attitude is admirable and inspiring.

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