Participaing in a clinical trial?

Darron said:

Stage

I am a big fan of trials. It isnt just about research, it is also about helping yourself. Do you have any evidence of cancer now? If so, the side effects of just About anything to treat our cancers will have a 30 page list of side effects....

Dont be shy, investigate and ask.

Darron, I'm curious to know if trials are something patients have to ask to be involved with.  Or, do doctors recommend them based on tumor type, size, grade, geographical location of patient, etc?  In other words, if I were eligible for a trial, would I KNOW I were eligible?  Can I assume that because my doctor didn't mention a trial, that trials aren't an option for me?

I'd appreciate your thoughts.

Sindy

JoanneNH said:

Darron:  I am a stage II due

Darron:  I am a stage II due to the size (7.5 cm).  No visible sign on preoperative scans of spread, and the margins were clear.  I will have a  CT of the chest, abdomen, and pelvis in about a month as a baseline postsurgery (9/17).   Oncologist said that I have a 20% chance of future cancer.  

 

This is the trial that was offered to me:      http://www.cancer.gov/clinicaltrials/search/view?cdrid=668388&version=HealthProfessional

 

I don't know how you can find out if you are eligible for a trial.  My doctor spoke to me about studies preop.  I have done two already:  one involved donating 8 vials of blood and the other was to allow researchers access to my tumor.  

 

 

 from what I understand, clinicaltrials.Gov is a good starting place. When I went to see my oncologist I thought I was stage II or III and was going to investigate the"Everest" trial. Much to my surprise, my surgeon was so impressed with my 17cm tumor that he missed the 3.4cm one on my other adrenal glad....welcome to stage IV, bye to the Everst trial.

the trials tend to be close to major medical areas, I live in the suburbs of Charlotte, only 20 minutes from the Levine Cancer Institute. My introduction to trials was by word if mouth from one if my son's friends mom. It was not from me searching, it just fell in my lap.

There are good odds you will never see cancer again, But I know that when I was post op and thought I was cancer free, I didn't want to sit and wait to see if it came back. I wanted to fight!

Where are you located? I will be happy to e-mail my trial nurse and see if she is aware of any preventative trials.

Some if thpulling time survivors here may have more info than me, but I will help how I can.

JoanneNH said:

Darron:  I am a stage II due

Darron:  I am a stage II due to the size (7.5 cm).  No visible sign on preoperative scans of spread, and the margins were clear.  I will have a  CT of the chest, abdomen, and pelvis in about a month as a baseline postsurgery (9/17).   Oncologist said that I have a 20% chance of future cancer.  

 

This is the trial that was offered to me:      http://www.cancer.gov/clinicaltrials/search/view?cdrid=668388&version=HealthProfessional

 

I don't know how you can find out if you are eligible for a trial.  My doctor spoke to me about studies preop.  I have done two already:  one involved donating 8 vials of blood and the other was to allow researchers access to my tumor.  

 

 

Ask questions and get answers from your doc. Here is a good list to start with. Note that the trial has to start within 84 days if surgery, so your clock is ticking if you want to try it. Also, it is a placebo trial, which means there is a 50% chance you will take a sugar pill And they will simply take blood and monitor you.

Good ? For the doc:

how often are visits? For how many weeks?

do I have a co pay every visit?

what will be monitored while I am on trial( blood, kidney, liver?)

does the trial cover scans? how many?

what are risks and side effects?

hope that helps!

I am in a study at Duke University. It is a double blind placebo study to see if votrient can inhibit the start of mets. My surgeon suggested I would be a good candidate because of my stage (lll) and the presence of sarcamatoid features (only 5%). He also referenced my age (50) and good health. The Cancer Center in the local regional hospital had a clinical study nurse that help me connect with Duke but I found the study on the NIS website.  It is a Phase 3 trial, meaning that it has already gone thru 2 phases looking at side effects etc and shows good potential for efficacy. There was an 80 day time line from surgery I think.   I pay for the standard care stuff (scans every 6 months) buts the Trial pays for the rest. It involves more frequent scans and bloodworK and votrient pills every day.    I like the fact I am being proactive and taking some semblance of control. And it was people willing to do clinical trials that has advanced treatment so well in the last 10 years. I like doing my part.    Another advantage is that should the cancer return I have an in at Duke.    There are a good number of trials out there and the list of questions that Darren created for you should help in your search.  I saw a good number in Boston when doing my search....so if you are in NH that might we a good place to start. Each hospital lists the clinical studies it is participating in on their website.    All my best. Lynn

Hi Joanne!  I am currently in the LY2875358 trial.  So far, it has not cost me anything except my valuable sick and vacation time from work.  My insurance co. covers the scans and the trial covers everything else ( I think), including my parking when I come in for infusions, blood tests, and scans.  So basically, there has been no out of pocket cost associated with the trial.  I haven't seen where they are billing insurance for anything other than the scans.

dhs1963 said:

Be careful with Adjuvant trials

I am not in any adjuvant theopy trials.  I have mSRCC, (solitary lung met).  Currently NED (but scan next week). 

The problem is the tumors can adapt to the medicine from the trial; a specific medicine might only work for 12 moths or so, then the tumor evolves and the drug is no longer effective. 

The way my Dr. explained it (at NIH) is you do not want to give up the 12-18 months of a drug while the cancer is not a threat.  If present, it will find a way around the the blocked growth mechanism.  Save it for when you need it.

Consider that before agreeing to a trial.  (FWIW, I am in a "clinical research setting" for familial kidney cancer).  At NIH, everything is covered.

I am so pleased you have pointed this out.  This factor should be seriously considered before entering into any clinical trial of adjuvant therapies based on the current crop of TKI's.  Not one has been shown to be effective.  And you risk losing the use of whatever drug is being tested if you later do develop mets.

I was given the opportunity to consider such a trial after my initial surgery back in May 2010.  I was NvED after my surgery but declined to participate (it was a clinical trial of Sutent as adjuvant therapy).  Even though I did develop mets 2+ years later, I am pleased I did not choose to enter this trial.  At this point in time I have gotten over one year on Sutent and it still seems to be going strong for me.

I am all for clinical trials that make some sense.  But the adjuvant trials just do not.

I'm in the Everest trial (everolimus). It's a good question. I asked, but didn't really get a good answer. I decided to do the study independent of that question.

The meds are provided free. The insurance company agreed to pay their part of the followups, blood work, and scans. It was not free. I have a 10% copay, and I had to pay it. It may not sound like much, but it did add up. The blood work every 6 weeks is mainly to monitor how I'm doing on the drug. The scans are just slightly more than would be normal in terms of what would have been done. I'm getting CT scans of my chest, abdomen and pelvis every 18 weeks. I pay my share of those.

So far I don't regret doing the study. I know many people on this site are against these adjuvant studies. I know this is not likely to work, but I felt at a 50% risk of recurrence, the risk was too high not to do something. I put some of my trust in the doctors participating in the studies. Perhaps I'm naive, but I assumed that they wouldn't be doing the study if they didn't have some hope that it might work.

Part of the reason I picked everolimus, was that my doctor told me in his experience the side effects were much more tolerable than votrient. And I considered that I didn't want to take votrient being NED, saving it in case I need it someday. And it seemed everolimus might have a better chance at being effective as an adjuvant therapy than votrient did because of the way it works on the cells at a cellular level instead of a systemic level like votrient attacking a tumor's ability to create a blood supply for itself.

Most of these post-nephrectomy adjuvant therapy studies require you to enter the study within a certain number of weeks of having your kidney removed. If anyone is interested in them, you have to investigate them immediately upon having your surgery.

Todd

Hi,

Just happened to check in today and thought I would add my 2 cents. I finished up the Everolimus trial back in March. No real side effects at all except my triglycerides were up by 200 points. Two months after the trial, I dropped 180 points so I know I was getting the drug and not the placebo. I had my 18 month scan a few days ago and go to the oncologist tomorrow to get results. My cost of the trial was co-pay for scans every 18 weeks and co-pays for oncologist every 6. Now that I am off the trial the insurance has preapproved me for scans every 6 months for the next 2 years. I am happy that I went on the trial as I felt like I was able to take my health into my own hands and try and do something about my situation.

Thanks,

Wayne

todd121 said:

Costs

I'm in the Everest trial (everolimus). It's a good question. I asked, but didn't really get a good answer. I decided to do the study independent of that question.

The meds are provided free. The insurance company agreed to pay their part of the followups, blood work, and scans. It was not free. I have a 10% copay, and I had to pay it. It may not sound like much, but it did add up. The blood work every 6 weeks is mainly to monitor how I'm doing on the drug. The scans are just slightly more than would be normal in terms of what would have been done. I'm getting CT scans of my chest, abdomen and pelvis every 18 weeks. I pay my share of those.

So far I don't regret doing the study. I know many people on this site are against these adjuvant studies. I know this is not likely to work, but I felt at a 50% risk of recurrence, the risk was too high not to do something. I put some of my trust in the doctors participating in the studies. Perhaps I'm naive, but I assumed that they wouldn't be doing the study if they didn't have some hope that it might work.

Part of the reason I picked everolimus, was that my doctor told me in his experience the side effects were much more tolerable than votrient. And I considered that I didn't want to take votrient being NED, saving it in case I need it someday. And it seemed everolimus might have a better chance at being effective as an adjuvant therapy than votrient did because of the way it works on the cells at a cellular level instead of a systemic level like votrient attacking a tumor's ability to create a blood supply for itself.

Most of these post-nephrectomy adjuvant therapy studies require you to enter the study within a certain number of weeks of having your kidney removed. If anyone is interested in them, you have to investigate them immediately upon having your surgery.

Todd

Todd, I keep reading your posts on adjuvant therapy.. and it appears to me you are reacting emotionally and not logically..  So far none of those kinds of studies showed any success.  Why those types of trials keep showing up is a wonder to me..?  Follow the money.. is what I think.  I am all for a trial that may lead to something positive, but this type just does not "pencil" to me.  Someone will quickly let me know if I am off base...

You keep saying your odds are 50%.. that may or may not be true.. does not really matter.  If you are stage 3 then anything can happen.

But what you fail to see is the negative of this type of trial..  First, since your insurance would cover the follow ups, then no gain there...  But there are only so many drugs we have.. and it is not a lot of them.  Not all drugs work for everyone.. that further can reduce the number of treatments you can get, if needed.  Sadly if you use up a good drug now, you won't have it later, so may lose time on your life clock..  There really is nothing to gain..  The only gain I can see is if you can not tolerate that drug for some reason.

I know you and many "think" you need to be pro active... Nothing is stopping you from being pro active..  Two of the best things you can do, is improve your diet and increase exercize..  I suspect Neil will chime in on the diet front..

I wish you luck...

Ron