I was treated to a little of the cancer-fighting establishment's scientific bias against alternative treatments last week, but the experience left me unconvinced that a plant-based diet is not helping me keep my cancer in check.
"There's no evidence for that," my doc, Wells Messersmith said when I asked if the diet could have had any influence on results of a scan taken March 2 and compared with an earlier scan from Jan. 19.
Messersmith methodically measured the 10 largest tumors (the biggest being about one inch long) still growing in my lungs, chest cavity and abdominal region March 9 to show me how progress or the lack of it against the cancer is determined by the folks who conduct clinical trials of new drugs.
An independent report written by a reviewer Messersmith said could be in Japan, India or anywhere else in the United States, suggested the numbers of tumors and the size of existing tumors had increased in me while I was taking the study drug Estybon (rigsertib) for six weeks this year.
But my doc was skeptical and liked to take his own measurements even though he did expect the latest scan to show my cancer had gotten worse. If it had, I would be withdrawn from the clinical trial: "You wouldn't want to keep taking it [and feeling the side effects] if the drug wasn't doing you any good, would you?" he asked me.
So he measured up my tumors and found that overall the cancer in me had grown by 13 percent over the six weeks. He questioned whether one shaded area of the scan actually represented more tumors, as the first reviewer seemed to be suggesting, and he noted that "worse," as described by most clinical trials, usually was a 20 percent overall growth of the cancer.
My CEA (a tumor marker in the blood) also had risen from 40.3 on Feb. 15 to 41.1 on March 9, another indicator things were not necessarily getting better inside me.
Still, Messersmith wanted to keep me on the drug for another month and scan me again at the end of March or mid April, right around tax time. He said he expected the cancer would continue to get worse and then I would be pulled from the study and enrolled in another trial to try to keep me alive.
He actually mentioned that a "cost/benefit" analysis is what determines whether a patient remains in the trial or not. The maker of the drug, Onconova Therapeutics Inc., Newtown, Pa., provides me the drug for free and picks up all the extra costs of my treatment related to using the drug. But like any business, the company doesn't want to keep paying for all that expensive stuff -- costs of the drugs and scans can easily run into five figures, sometimes six -- if the trial shows the drug is not doing the patient any good.
That's the most significant lesson I have learned in participating in two clinical trials. The drug manufacturers, while hoping for the best for the patients testing their experimental drugs, are businesses that don't want to waste money where the drug isn't working the way it should, even if it is keeping rapid deterioration of the patient's condition at bay.
All the consent forms for these trials inform the patient they have been chosen for participation because standard treatments for their late-stage cancers have already proven ineffective; the cancer inside them might run riot if the trial drug doesn't help slow or stop its spread.
Those who advocate alternative treatments for cancer often criticize the scientific, medical and business communities that test new drug treatments for recruiting late-stage patients to a trial that also calls on those patients to forego alternative treatments while enrolled in the study.
That's why the cancer-fighting establishment is known -- and also criticized for -- testing drugs that provide a late-stage patient with only a month or two of life, and effectively write off the patient's life as collateral damage when the drugs don't work.
That old practice -- now cancer fighters are much more enlightened about the "potential" benefits of alternative treatments -- was also made clear to me by my experience with this new drug. A one-month commitment to the drug is not very long.
But Messersmith and his team at the University of Colorado Hospital and the Anschutz Cancer Center have allowed me to continue my "alternative" ways through this trial: a plant-based diet, some additional Vitamin C and flaxseed-oil supplements.
I admit that when Messersmith told me I was the only patient in the trial he knew who was experimenting with a plant-based diet, I rushed out to the grocery store to buy three half-gallons of "dairy" ice cream and looked forward to a nice juicy steak.
But then I re-thought about making that choice.
No evidence that a plant-based diet restores the natural immune system to a point where it can fight cancer by itself is not necessarily evidence that it does not.
And if I am the only patient on a plant-based diet involved in this trial and my cancer hasn't grown more significantly in a month on a lower dose of the drug than it did during the first six weeks on it, maybe I'll be manufacturing some evidence the drug companies should pay attention to. We'll see.
In the meantime, it's back to beans and nuts for me. I'll cheat a little with that ice cream still in my freezer, but not much. And if I last the month, there may still be plenty of time for that juicy, half-cooked steak. Scotch on the side.
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Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
Thursday, March 15, 2012
Tuesday, January 31, 2012
In the Chemo Room, again
Well, I was back in a Chemo Room all day on Friday, although I was only there to take two pills and have my blood tested nine times over 11 hours, and to collect every drop of urine I could pee.
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:
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?
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?
Labels:
cancer,
clinical trials,
Onconova Therapeutics
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