I'm entering a new clinical trial for a drug that has been widely tested on others and that is now given orally and requires me to keep a diary of the times I take it twice a day at home. The pee collection continued at home, too, for the remainder of 24 hours. You have to refrigerate the pee until your next appointment when you bring it in and they finish checking out how quickly your body takes up and disposes of the chemical.
So after that first day, you go in once a week so they can retest your blood and urine. After a while, I'm sure they'll scan me to see if the drug -- this one is called Estybon (rigsertib) and designated ON 01910.Na for the study -- is working any magic on my tumors.
It's still a Phase 1 study, but the clinical trial has gone on so long that the docs have pretty much determined what the best dose is, especially regarding peoples' tolerance to its side effects.
The goal of the study now is to determine how effective it can be at stabilizing the growth and spread of tumors in advanced-cancer patients. It's manufactured by Onconova Therapeutics, a small drug maker out of Newton, Pa., and Pennington, N.J.
I was told I was one of the few colorectal cancer patients being tested at least locally, but the company says this about its drug:
ESTYBON (rigosertib) is a novel multikinase inhibitor, with selective cytotoxic effects on tumor cells without impact on normal cells.... A significant effect of ESTYBON in cancer cells is the induction of multiple centrosomes during cell division, resulting in a multi-polar spindle and total disorganization of the mitotic apparatus, a phenomenon called chromosomal catastrophe….
Given the unique mechanism of action on tumor cell survival pathways, ESTYBON has the potential to be active against a wide variety of cancers.... Early clinical results from ESTYBON combination studies with either oxaliplatin or gemcitabine indicate rapid response in pancreatic, breast, colon, ovarian, and lymphoma patients, suggesting multiple indications for solid tumors.
That's typically dense language for cancer-drug descriptions, but it is what we patients find hopeful even if we don't understand all of it.
I'm still feeling out the side effects this drug will produce in me. The consent forms I signed list practically every side effect known to cancer patients as having been experienced by 2 percent of the people who have been enrolled in the trial. That means only that two out of 100 enrolled patents have experienced just one of the side effects in the long list.
If you give enough cancer patients any drug over a long period of time, you can bet that one will feel at least one side effect he or she has experienced on some other chemo drug and claim it is a repeat of that symptom under the new drug. That's the nature of clinical trials.
I reported more familiar symptoms under the first "study drug" I took than I think the docs wanted to count, but they were required to count them even though I'm sure they thought I was re-imagining old hurts and past responses.
The big side effects to look for under this drug are fatigue, nausea, diarrhea, decreased appetite, and painful urination. I'm happy to report none of them so far, although it seems I am dancing with diarrhea again. The condition encourages anticipation anxiety, so you don't really know what you've got until it hits. One thing is sure: I have no decreased appetite to report.
And I was able to play croquet on Monday, and drink a beer while once again losing the game. Who can ask more of life than a pleasant game of croquet?