Stivarga Trial / Ozone Therapy

[Abee&Jaclyn]

Hi
We are new here, my bf just got diagnosed with stage IV colon cancer, he is 58, had colon cancer 3 years ago, had surgery, successfully removed affected part of the colon.

He has ok for the last three years, but in January 2016 some lesions were detected on his liver, apparently metastasized from the colon cancer. We are seeing Dr Saltz in Sloan Kettering, who after going back and forth thinking he was a candidate for resection, now we are being told that chemo should be done first. So surgery has been taken of the table for now. He offered him to get on a clinical trial because his lesions are small, under 1 cm, and don't seem to be growing too fast.

One of the suggestions was to go on a clinical trial of Stivarga® (regorafenib)‎. He said that until now this drug was given to patients who stopped responding to other chemotherapies, and in those cases patients lived another 1.5 months. The study we are being asked to participate in is being done on patients who never had any chemo treatments before. It is a hard decision to make, since there is no real statistics one way or another. He said he has had both successes and failures .
So we are wondering if anyone has any thoughts on this? Wondering if this is beneficial for the hospital? Are they really thinking about the patient here, or just because he is in such an early stage, do they feel they can learn on him??


ON ANOTHER NOTE:
We are thinking, since we seem to have some time (Dr says he can start at the end of April if he wants, since he seems to be progressing slowly) we heard about Ozone Therapy. Has anyone had any success with this? The premise is that cancer cannot survive with oxygen, the Ozone is injected into the body, (rectally) and floods the body with oxygen thereby killing off the cancer cells or at least minimizing them. According to this holistic doctor we went to, he does biofeedback, Ozone therapy and also a pretty strict diet eliminating sugar and carbs and eating very healthy.

Any feedback anyone may have is very welcome, we need some insight here!

Jaclyn

[midlifemom]

Hi and welcome.
I don't know about this stivarga trial but there are a few members here who have tried stivarga. I understand it to have rough side effects. You should search the posts to read some first hand experiences for yourself. However, since this has stivarga as a first line therapy, I wonder if the dose is different.
Good luck!

[stu]

Hi.
My mum has been a stage 4 patient for nearly seven years and during that time she has participated in several trials when they made sense. Recently she had a met in her lung, small and operable. Despite being in her seventies with stage 4 disease she is incredibly healthy. Surgeons apparently have no research to compared surgical outcomes for lung Mets against a control arm that would be monitored but untreated. If disease required surgery at some point it would be reviewed. This is an international trial and my mum fitted beautifully into the trial criteria. Quite a hard sell was presented and somewhat stressful considering stage 4 disease is hard enough to navigated. My mum always prefers surgery where possible and after much discussion she declined. I genuinely felt it was more in the trials interest than my mum's. It is a pressing question but it was also a big ask. We all had mixed emotions after the meeting . She has since had surgery and all went well.
The pressing question it seems given the side effects reported with this drug is in their professional opinion would it be as sever and if so would he really want that experience. My mum went from inoperable to operable twice with chemo and if it was me I would want to ensure it did not cause health issues that might prohibit that from happening.
I certainly think they have more questions to answer.
Kind regards
Stu

[JJ2212]

Hi Jaclyn,

I'm currently on Stivarga, under a clinical trial at my hospital in Montreal. The trial is for patients with mcrc having failed first line chemo (folfox in my case) only. As you mentioned, Stivarga is usually reserved for patients having exhausted 1st and 2nd line chemo options, therefore are not necessarily in the best of shape when starting Stivarga.

I can't answer your question for sure about what the hospital may be getting out of the trial, but sure, I do feel like I'm somewhat of a guinea pig. The thing with most clinical trials IMO is that the outcome is not known and is no guarantee that it's the best option for you. The trial i'm in is trying to identify markers that may predict response in patients, so hopefully it will benefit someone in the future

That being said, I've had 15 cycles of Stivarga and am doing fine. My lung met and lymph nodes decreased in size and have been stable for a year now. Anecdotally, my onc tells me that I'm one of the lucky ones. He's seeing less than a 20% response rate, but that's on a small sample size (around 35 patients). The first few cycles were rough until we finally found the right dose for me (80mg / 2 pills per day). I still have quite a few side effects, but most are annoyances that last 10-14 days per 28-day cycle. I stopped working because of the fatigue and occasional hand/foot syndrome though.

When I was offered the clinical trial, I sort of said yes before really deciding if this was the best option for me. I didn't know if I should push for surgery or SBRT, but thought that I could try Stivarga a few months while I investigated my options. That was 16 months ago and I have no regrets. I have no idea how long Stivarga will work for me, but it's working now so I'm happy.

I know it's a stressful time when you have to decide a treatment path out of the norm, but you're doing the right thing. Gather info, get a 2nd opinion if you can and trust your team.

Feel free to pm me if you have any questions. Take care. Janie

[H is for Hawk]

The "cancer can't survive in an oxygen environment" theory is too simplistic and never made any sense to me. Lung cancer, for example, grows just fine where it is exposed to oxygen (air) 24 / 7.

[vilca11]

Hi Jaclyn,

About Ozone - that treatment, combined with the Vit C+K3 IV infusions, does prolong life, but is not a cure. So, to sustain a patient for a year or so, it might be quite effective, from what I saw.
Vilca

[debb]

Hi...i have same doc and was offered same trial, about a year ago. I participated. The hope for the trial is to use stivarga as a second line treatment for mcrc. i know some here have reported bad side effects of this drug, but many of those patients here are using it as 4th line and at that time, cancer and it's side effects and the effects of past treatments come into play. I was training for a 1/2 marathon at the time I was offered participation in this trial...i had a few small lung nodes that we had been watching. I participated in the trial, and had no real side effects (kept training for the 1/2), but one day i woke with the biggest rash all over and kind of felt like i had a flu. For this, i was excluded from the trial.

Participating in the trial means being monitored more closely, and more frequent scans and blood draws. I definitely liked that. I knew that the minute it looked like my cancer was progressing, I'd be off stivarga and on to more traditional treatment. So I didn't feel like I'd lose time in treating this disease. At the time I presented with the rash, if i had not been participating in the trial, my dose could have been adjusted. But the purpose of the trial needs the stated dose. So I'm hopeful stivarga could be a tool in my toolbox at a later date.

i have been a patient of our doc for my entire journey, and he is not in this business to boost any bottom line. Quite the opposite actually (google him). If stivarga does prove to be a good use as a second line treatment for mcrc, it would save patients lots of time and money. No infusions, just a few pills each day and hopefully no disease progression.

Being in a trial is a very personal decision. There is fear of the unknown and also the commitment to more frequent doc visits for closer observation. You need to do what feels right in your heart. I just wanted to add my experiences to help you weigh options. Good luck to you.

[jhocno197]

I think the Ozone thing sounds ridiculous...cancer uses the blood in your body, which has oxygen in it...

My husband is on Stivarga (after failing folfox & folfiri) & doing ok (only one cycle in); no nasty side effects & a decent CEA drop so far.

And this about ozone therapy:

Much of the concern related to ozone therapy revolves around the safety of blood ozonation. It is well established that when inhaled by mammals, ozone reacts with compounds in tissues lining the lungs and triggers a cascade of pathological effects. Saul Green has argued that since ozone has the capacity to oxidize organic compounds in an atmospheric environment, it should also logically oxidize blood components and endogenous human tissues.[15] When infused into human blood, ozone produces reactive oxygen species (ROS) or free radicals,[16] an over-abundance of which is known to cause oxidative stress and cell damage, and is implicated in the progression of some degenerative diseases. High levels of inhaled ozone is known to be toxic, though single-dose inhalation of lower levels is not.[17]

Serious complications reported from the use of this therapy include the development of hepatitis and also include five reported fatalities.[11]

[vilca11]

I do not know about Ozone inhalation, did not have any experience with that, but witnessed the effect of the Ozone injections + Vit C + K3 IVs + IVs with various minerals and vitamins: a dying person, non-functional, stage 4 throat cancer, brought back to life in a fully functional mode up to 1 mo before death - lived 1 more year of a normal life.... No chemo, no other conventional treatments thru the whole history of the disease, found out too late, half a year before his complete demise... at which point he started Ozone injections and naturopatic IVs ....
Hugs, vilca