Choosing a Clinical Trial

Cazz

I have posted this on the anal forum as well as its a general topic.

My first scan to see the efficacy of Erbitux is in a couple of weeks.  As I have never had a chemo that has made a dent on my liver, lymph etc. mets, I don't hold out much hope here either, so I've been researching clinical trials, again.  How is one supposed to figure all this stuff out?  I've found a couple that sound interesting, but interesting enough to fly from San Francisco to Boston three times a month?  It all seems a bit of a crap shoot.  I have printed out my latest top two picks and will take them in to my local oncologist for his input, but I can hardly ask him to go through all of the trial descriptions online and pick what he thinks is best for me out of the top 15 - 20.

How do you guys do it?  Have you got friends with medical backgrounds willing to help, or do you have a staff person at your treatment center who is tasked with helping to narrow the lists down and advise you?  Its all a bit overwhelming for me, but I'd hate to miss out on something worthwhile just because I don't understand the criteria terms.

Just wondering.

John23

Since you're "wondering".....

Since you're "wondering".....

There's no known "cure" for cancer, but there are different ways and options to western medicine to fight it.

Click on my name/moniker and go to the "blog" section. You'll have to click the "read more" to read the entire post....

Tumors are best removed surgically ASAP. How you fight the balance is up to you. You should always get a second (and third or more) opinion from colorectal surgeons that are not of the same group or organization as the original physician. I put too much trust in one gastroenterologist and ended up in a really bad place now! Do NOT let that happen to you!

If you want to be a Guinea Pig for the medical industry, go for it. But when there's a medical science that's been around for almost four thousand years, and being used in some of the finest cancer clinics, I personally think it would be foolish to disregard it.

Read my Bio, and the blog..... And please.... get other opinions from qualified colorectal surgeons.

Hoping for your wellness!

John

 

takingcontrol58

On Choosing a Clinical Trial

Cazz,

I recommend you read my post "How my liver mets disappeared on their own".
I had mets to the liver, spleen (largest lymph node in the body) and a 5cm tumor on my outer
rectum. I was diagnosed with Stage IV metastatic endometrial cancer, which has the same risk
factors as colon cancer.

The drug metformin put me in complete remission in 6 months from the day I started the drug in Feb 2015. I remain
on the drug and have not had a recurrence for one year.

I originally joined a trial at the top cancer center in the country in NYC, but removed myself and my own oncologist prescribed
the drug for me because he was clearly aware of its anti cancer properties plus I was insulin resistant.  I needed the drug.
I was told I had 4-6 months to live because I had so many metastases after my surgery.  I've done alot of research
on cancer and the cancer treatment industry because I was told I was going to die and I didn't believe them.  Instead of
dying, I went into complete remission.

There are many ongoing trials with metformin but please don't enter a trial to get the drug. Your doctor can just
prescribe it to you. It's called "off label" prescribing. Don't let them tell you that you have to enter a trial for the drug.  
If you have metastasis, you don't have time to wait for some useless trial to end. Metformin has been around since 1958.  It is the most
prescribed diabetes drug in the world plus is anti cancer.  The smart oncologists who know its benefits prescribe it to their patients.

Also, Metformin does what Erbitux does, with limited side effects.  It inhibits EGFR (Epidermal Growth Factor Receptor). With
none of the serious side effects.  Metformin also kills cancer stem cells, which are the source of cancer growth and metastasis.
Metformin also stops angiogenesis- the creation of new blood vessels- tumors grow new blood vessels to feed them. The chemo
drug Avastin is supposed to do this but has serious side effects.  It's like metformin does what multiple cancer drugs try to do.

It does many other anti-cancer things. They have many drugs in development that are trying to do what metformin already does.
 I would highly recommend you tell your doctor you want to try it before you enter any new trials and get more poisonous drugs.

Do you mind telling me what trials you are considering or what drugs? Do you know what mutations you have?

Takingcontrol58
Taking control of your cancer is how you survive

 

 

 

 

 

 

 

 

annalexandria

I am the admin for a crc FB group

and we have one member who is a cancer researcher (also a stage 4 patient), who is very knowledgable about these issues.

You do need to have a FB account to join.  If you're interested, the name of the group is Colorectal Cancer Survivors Unlimited.

Cazz

takingcontrol58 said:

On Choosing a Clinical Trial

Cazz,

I recommend you read my post "How my liver mets disappeared on their own".
I had mets to the liver, spleen (largest lymph node in the body) and a 5cm tumor on my outer
rectum. I was diagnosed with Stage IV metastatic endometrial cancer, which has the same risk
factors as colon cancer.

The drug metformin put me in complete remission in 6 months from the day I started the drug in Feb 2015. I remain
on the drug and have not had a recurrence for one year.

I originally joined a trial at the top cancer center in the country in NYC, but removed myself and my own oncologist prescribed
the drug for me because he was clearly aware of its anti cancer properties plus I was insulin resistant.  I needed the drug.
I was told I had 4-6 months to live because I had so many metastases after my surgery.  I've done alot of research
on cancer and the cancer treatment industry because I was told I was going to die and I didn't believe them.  Instead of
dying, I went into complete remission.

There are many ongoing trials with metformin but please don't enter a trial to get the drug. Your doctor can just
prescribe it to you. It's called "off label" prescribing. Don't let them tell you that you have to enter a trial for the drug.  
If you have metastasis, you don't have time to wait for some useless trial to end. Metformin has been around since 1958.  It is the most
prescribed diabetes drug in the world plus is anti cancer.  The smart oncologists who know its benefits prescribe it to their patients.

Also, Metformin does what Erbitux does, with limited side effects.  It inhibits EGFR (Epidermal Growth Factor Receptor). With
none of the serious side effects.  Metformin also kills cancer stem cells, which are the source of cancer growth and metastasis.
Metformin also stops angiogenesis- the creation of new blood vessels- tumors grow new blood vessels to feed them. The chemo
drug Avastin is supposed to do this but has serious side effects.  It's like metformin does what multiple cancer drugs try to do.

It does many other anti-cancer things. They have many drugs in development that are trying to do what metformin already does.
 I would highly recommend you tell your doctor you want to try it before you enter any new trials and get more poisonous drugs.

Do you mind telling me what trials you are considering or what drugs? Do you know what mutations you have?

Takingcontrol58
Taking control of your cancer is how you survive

 

 

 

 

 

 

 

 

Trials

Thanks, John23 - I am not a candidate for surgery as there are too many mets in too many places.  They wouldn't even remove my liver mets last year while they were still small enough to be manageable because I had three of them and another tumor in my calf.  Unfortunately, I know nothing about Chinese herbal medicines and don't feel I have enough time to spend trying to learn about them now. 

Takingcontrol58.  I did read, with great interest, your post on the Metformin and asked my doctor about it today.  He was non-committal and suggested we wait and see what my next CT shows in two weeks, but he was open to the idea.  I think he is open to just about anything because the conventional chemos don't seem to do anything.  I was looking at a trial of Pembrolizumab, but my doc said that is basically the same thing as the Nivolumab (Opdivo) that I did last year.  Another trial is at MDAnderson combining metformin and Temsirolimus, unfortunately its only a Phase I trial, but Temsirolimus is one of only two drugs that the Foundation One (genetic testing) thought might help.  That testing came up with five mutations, but they are all strange labels, nothing like the KRAS or the BRAF(?) that people talk about.  I have mutations of genes TP53, which is commonly associated with pancreatic cancer (I've got anal cancer),  NTRK1 associated with thyroid cancer, PIK3R1 - uterine cancer and glioblastoma and a couple of others.  The only other drug Foundation One suggested was Everolimus, also known as Afinitor, which is FDA approved for treatment of breast cancer and kidney cancer.

I am really pleased for you that the metformin worked so brilliantly and I am trying desperately to find something that will do the same for me, but the only thing that has worked so far has been radiation.  I've got to find something systemic that kills all of the cancerous cells no matter how they have mutated nor where they are hiding.  I am going to MDAnderson for a CT in two weeks and if Dr Eng tells me that the Erbitux isn't working then I will ask her about combining Afinitor and Metformin and see what she has to say about it.  In the meantime, my local oncologist has said he will check on trials for me and see if there is anything suitable coming up.

MS2014

annalexandria said:

I am the admin for a crc FB group

and we have one member who is a cancer researcher (also a stage 4 patient), who is very knowledgable about these issues.

You do need to have a FB account to join.  If you're interested, the name of the group is Colorectal Cancer Survivors Unlimited.

Question for annalexandria

Good morning annalexandria

if you don't mind, could you talk about the metformin therapy with that person in the group that ha knowledge about cancer and please post us his reply

Could be interesting for this forum

BR

takingcontrol58

Cazz,

I am glad to hear your doctor is open to metformin.

I also had genomic testing through Foundation One.  One of my mutations was PlK3R1, just likeyou.
This mutation is part ofthe Pl3R1/akt/Mtor pathway, which is one of the most mutated pathways in
many cancers, not just uterine cancer like me. T53 is a tumor suppressor gene on this pathway that
is suppressed in many cancers. 

My Foundation One report also recommended Affinitor and Temsirolimus for me.
My integrative oncologist who put me on metformin also recommended I take Affinitor as well but
I refused because I had such miraculous results with just the metformin.  Why take on unneeded risk
if you don't have to.  If the metformin hadn't worked, maybe I would have tried the Affinitor. But I
understand that Affinitor targets the Mtor part of the pathway (our mutations our on the other part of
the pathway). Metformin inhibits the entire pathway.

My theory is that if you can try a non-toxic drug first that might work, I would do that before getting more chemo drugs.
These targeted drugs have side effects just like chemo.

Just so you know, the results with Affinitor and Temsirolimus haven't been so great. You can read the
medical studies.

If it was me, I would ask your doctor to put you on metformin now for the next two weeks so you can see if it
has any effect before your next CT scan, and not wait.  I had major results in just one month. You never know.

Do you mind telling me your other mutations? My other 3 mutations were CTNNB1, RB1and SF3B1. No drugs
exist for these 3 mutations but I found out metformin targets a key pathway tied to the CTNNB1 mutation.

I think the reason all these targeted drugs are not working is because they only target one mutation, and like you
indicate, you have many mutations.  If the drug targets the mutation that caused your cancer, then you win, but
so far their results are limited.

Takingcontrol58

 

 

annalexandria

MS2014 said:

Question for annalexandria

Good morning annalexandria

if you don't mind, could you talk about the metformin therapy with that person in the group that ha knowledge about cancer and please post us his reply

Could be interesting for this forum

BR

I asked our resident cancer researcher, his reply was...

"There is a scientifically plausible chance it could help as a potential immune booster and/or impacting insulin/IGF1R driven CRC growth. It has been on my "to-do list" for a long time but kept falling through the cracks (not for a good reason - just kept falling through). I just recently asked for a prescription myself - picking up the bottle this weekend and as of right now I plan on starting to take it. Not medical advice but my personal choice... Here is the relatively recent immune paper:  http://www.pnas.org/content/112/6/1809.abstract

 

Other group members also commented, one said she took it for a while but had side effects that were bad enough to lead her to stop th drug, and one pointed out that she has been taking it for years for diabetes and still ended up with stage 4 cancer (tho it sounds like the dosage was half that given to cancer patients). 

So perhaps not a "magic bullet", but it does sound like it would be worth adding, so long as the SEs are tolerable.

 

Hope that helps!

MS2014

annalexandria said:

I asked our resident cancer researcher, his reply was...

"There is a scientifically plausible chance it could help as a potential immune booster and/or impacting insulin/IGF1R driven CRC growth. It has been on my "to-do list" for a long time but kept falling through the cracks (not for a good reason - just kept falling through). I just recently asked for a prescription myself - picking up the bottle this weekend and as of right now I plan on starting to take it. Not medical advice but my personal choice... Here is the relatively recent immune paper:  http://www.pnas.org/content/112/6/1809.abstract

 

Other group members also commented, one said she took it for a while but had side effects that were bad enough to lead her to stop th drug, and one pointed out that she has been taking it for years for diabetes and still ended up with stage 4 cancer (tho it sounds like the dosage was half that given to cancer patients). 

So perhaps not a "magic bullet", but it does sound like it would be worth adding, so long as the SEs are tolerable.

 

Hope that helps!

Thanks so much Annalexadria

and please

I don't want to be rude asking and asking but just if you have the time, and the researcher 

Could you ask him the following?

What would be the regular dose for a person without cancer (diabetic or insuline resitant I guess)?

What could be the potentally good dose to help chemo get rid of mets? (Just your thoughts, but your appetiation would be better than mine)

What could be the potential side effects for a no diabetic person that uses mertformin?

For granted it is not medical advice but a way to share knowledge that ...who knows could be a bullet to use just in case.

My mother has many medical issues right now, but I allways have a  B, C, Plan, Metformin as you say is in the list

Thanks again for your help

 

annalexandria

MS2014 said:

Thanks so much Annalexadria

and please

I don't want to be rude asking and asking but just if you have the time, and the researcher 

Could you ask him the following?

What would be the regular dose for a person without cancer (diabetic or insuline resitant I guess)?

What could be the potentally good dose to help chemo get rid of mets? (Just your thoughts, but your appetiation would be better than mine)

What could be the potential side effects for a no diabetic person that uses mertformin?

For granted it is not medical advice but a way to share knowledge that ...who knows could be a bullet to use just in case.

My mother has many medical issues right now, but I allways have a  B, C, Plan, Metformin as you say is in the list

Thanks again for your help

 

The person who is taking it for diabetes

is taking 750 mg 2x per day, while another member who is taking it for cancer is at 1500 mg 2x per day.

The NIH has a good overview of potential side effects.  I would def want to talk with a doctor before taking this (or any!) drug.

https://www.nlm.nih.gov/medlineplus/druginfo/meds/a696005.html

MS2014

annalexandria said:

The person who is taking it for diabetes

is taking 750 mg 2x per day, while another member who is taking it for cancer is at 1500 mg 2x per day.

The NIH has a good overview of potential side effects.  I would def want to talk with a doctor before taking this (or any!) drug.

https://www.nlm.nih.gov/medlineplus/druginfo/meds/a696005.html

Thanks for the reply

Great information

Hope it is one step for all of us

John23

Cazz said:

Trials

Thanks, John23 - I am not a candidate for surgery as there are too many mets in too many places.  They wouldn't even remove my liver mets last year while they were still small enough to be manageable because I had three of them and another tumor in my calf.  Unfortunately, I know nothing about Chinese herbal medicines and don't feel I have enough time to spend trying to learn about them now. 

Takingcontrol58.  I did read, with great interest, your post on the Metformin and asked my doctor about it today.  He was non-committal and suggested we wait and see what my next CT shows in two weeks, but he was open to the idea.  I think he is open to just about anything because the conventional chemos don't seem to do anything.  I was looking at a trial of Pembrolizumab, but my doc said that is basically the same thing as the Nivolumab (Opdivo) that I did last year.  Another trial is at MDAnderson combining metformin and Temsirolimus, unfortunately its only a Phase I trial, but Temsirolimus is one of only two drugs that the Foundation One (genetic testing) thought might help.  That testing came up with five mutations, but they are all strange labels, nothing like the KRAS or the BRAF(?) that people talk about.  I have mutations of genes TP53, which is commonly associated with pancreatic cancer (I've got anal cancer),  NTRK1 associated with thyroid cancer, PIK3R1 - uterine cancer and glioblastoma and a couple of others.  The only other drug Foundation One suggested was Everolimus, also known as Afinitor, which is FDA approved for treatment of breast cancer and kidney cancer.

I am really pleased for you that the metformin worked so brilliantly and I am trying desperately to find something that will do the same for me, but the only thing that has worked so far has been radiation.  I've got to find something systemic that kills all of the cancerous cells no matter how they have mutated nor where they are hiding.  I am going to MDAnderson for a CT in two weeks and if Dr Eng tells me that the Erbitux isn't working then I will ask her about combining Afinitor and Metformin and see what she has to say about it.  In the meantime, my local oncologist has said he will check on trials for me and see if there is anything suitable coming up.

metformin

 

Everything has it's price. Side effects can be costly.

http://www.askapatient.com/searchresults.asp?searchField=Metformin

 

 Best wishes fr best health,

John

 

Cazz

takingcontrol58 said:

Cazz,

I am glad to hear your doctor is open to metformin.

I also had genomic testing through Foundation One.  One of my mutations was PlK3R1, just likeyou.
This mutation is part ofthe Pl3R1/akt/Mtor pathway, which is one of the most mutated pathways in
many cancers, not just uterine cancer like me. T53 is a tumor suppressor gene on this pathway that
is suppressed in many cancers. 

My Foundation One report also recommended Affinitor and Temsirolimus for me.
My integrative oncologist who put me on metformin also recommended I take Affinitor as well but
I refused because I had such miraculous results with just the metformin.  Why take on unneeded risk
if you don't have to.  If the metformin hadn't worked, maybe I would have tried the Affinitor. But I
understand that Affinitor targets the Mtor part of the pathway (our mutations our on the other part of
the pathway). Metformin inhibits the entire pathway.

My theory is that if you can try a non-toxic drug first that might work, I would do that before getting more chemo drugs.
These targeted drugs have side effects just like chemo.

Just so you know, the results with Affinitor and Temsirolimus haven't been so great. You can read the
medical studies.

If it was me, I would ask your doctor to put you on metformin now for the next two weeks so you can see if it
has any effect before your next CT scan, and not wait.  I had major results in just one month. You never know.

Do you mind telling me your other mutations? My other 3 mutations were CTNNB1, RB1and SF3B1. No drugs
exist for these 3 mutations but I found out metformin targets a key pathway tied to the CTNNB1 mutation.

I think the reason all these targeted drugs are not working is because they only target one mutation, and like you
indicate, you have many mutations.  If the drug targets the mutation that caused your cancer, then you win, but
so far their results are limited.

Takingcontrol58

 

 

Taking Control

Great handle, by the way!

The other two mutations they came up with were NF1 and PIK3R1.  They suggested Afinitor for both as well as temsirolimus aka Torisel, never heard of them either.

I won't start on metformin or anything else until we see the results of the CT scan in two weeks.  I suspect that it will be very depressing and stuff will have grown and new ones started up all over the place - this is based on an MRI I got last week that showed that the tumor in my calf that I had radiated away in November 2015 has recurred and is at 7 x 4.7 x 3.2 cm already, this despite being on Erbitux for the last 7 weeks.  I am hoping that what really happened is that they just didn't get it all and don't want to admit it.

So I really need to get the CT done and see what Dr. Eng has to say about it all.  I will definitely mention the metformin to her, but she said that she was hoping a new immunotherapy trial would finally open up as she wants to get me in that, and obviously, I wouldn't be able to take anything that doesn't mesh with the trial.

Carol

Sue_2015

I'm wondering too,

I'd like to follow along here.  I'm at the point where my doc says no chemo treamtents are working since I have new liver mets and a probably lung mets (biopsy next week for that.)

I'll be looking into clinical trials too but wouldn't know how to begin.

The Y-90 (SIRT) procedure did shrink my largest liver tumor (on the right side) somewhat and now they want to do the procedfure on the left side where new mets are.  I'm all for it.  Although, currently, I'm in a state of limbo and more confusion.  Whenever I ask after resection of the colon or liver tumors all I get is "we have to shrink all the tumors first before surgery can be done."  Sigh

Good luck and best wishes on this journey.  Please keep us posted.

Sue