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  #1  
Old 07-31-2008, 08:45 PM
MikeHi@anon.com
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Default My next step, Trials options.



Hi all,

Went for my first appointment to my new medical oncologist (SJ -
thanks for the push). He was away on holiday. I was so surprised, that
I said, 'Oh, dear me', this being the regular lot of any NHS patient
seeing 'their' consultant. My new doc went about seeing what trials
might be available to fit me into, which is exactly what I wanted.

I appear to qualify for only one trial - "Stampede". Briefly, I would
have to take standard androgen suppression, plus a) any one of Zometa,
Taxotere or Celecoxib, or b) plus a combination of Zometa with either
Taxotere or Celecoxib. The aim is to assess which of the five combos
could make AS benefits last longer. The computer allots at random.
The control arm is standard AS (though we can agree what exactly with
doc.). (It all sounds very kh'ish.)

At 80 years of age but still suspiciously alive, my info sheet (me,
not the info sheet, is old) reads: "It is expected it will take six to
ten years to complete the study". H'mm.

And as my readers will be aware I have heartily supported Scardino,
who suggests with total conviction (podcast) that toxic HT/chemo which
becomes refractory and then opens up new Pca pathways, is on its last
legs. (See my notes on his podast in my post June 25th. Or listen for
yourself at:
http://www.researchtopractice.net/podcast/feed/PCU.xml )

The logic which now screams at me, which is totally mashing me, peeing
me off big time, makes me want to tear out the rest of my hair,
foiling my attempt to grow it into a fashionable pony tail at the
back, is as follows:

If there are therapies in late stages of development which might be
the replacement for HT toxics (e.g. abariderone, white cell
immunotherapies, and Lipitor + Celecoxib all discussed recently, to
name a few), then…

.....WHY THE **** ARE THERE NO TRIALS WHERE THE CONTROL IS THE
STANDARD HT AND THE TRIAL IS THE REPLACEMENT FOR THE HT and all its
side effects????/????? here's a few more???????? ?? SOMEBODY PLEASE
EXPLAIN.

Current abariderone trials for example will tell us if the drug will
renew therapy after chemo has failed. That's fine. And a correct
priority. But why are there no parallel trials to establish if it
could help those with advanced cancer and poor prognostics *instead*
of the toxic stuff? And my reading of the research report on AA
(discussed here also very recently) confirmed its efficacy against
cancer tumors whether or not they'd already been subjected to
HT/chemo.

THAT is what should be available, surely, somewhere, NOW. I would
prefer not to have years of toxic side effects, some of them permanent
while being quite certain in my heart that these are the last days of
current HT treatment. Of course I also realise, and it is what is
pointed out to me, that currently only AS is available as a known way,
for all its faults, of hampering metastastic disease, which I have,
from taking off and becoming rampant.

If I don't accept the trials I'll get HT anyway, it seems. Ain't
nothing else in the kit. So, to save my coiff, at this moment in
writing I will probably accept to go on the trial. These are five
trials all at once - and so they should well prove something useful if
one of them turns today's temporary HT improvements into something
more permanent. I guinea-pigged G9 HIFUs twice, and in three years of
an aggressive condition still haven't any of the very difficult
side-effects reported by guys who've had RP and radiation to attack
their primary source. So it will give me a certain amount of
enjoyment to continue dancing round the miserable microns of the Pca
army, sticking it to them as an ongoing labrat. And in the time given,
wait with confidence for their final slaughter by the new stuff.

I go back in a week, to sign up. In that same time the docs will have
another look and confirm I'm accepted. I've got all details and I
seem to fit the parameters.

I'll start reading through kh all over again and get some of his food
stocked. (Wonder if they'll accept a suggestion to have kh's menus as
a trial arm?).

My very best wishes to everybody.

MikeHi
"Exponential lightspeed". Def: The discovery of the cure for Pca at a
speed which defies Einstein.



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  #2  
Old 08-01-2008, 09:48 PM
Alan Meyer
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Posts: n/a
Default Re: My next step, Trials options.

MikeHi@anon.com wrote:
> ...
> ....WHY THE **** ARE THERE NO TRIALS WHERE THE CONTROL IS THE
> STANDARD HT AND THE TRIAL IS THE REPLACEMENT FOR THE HT and all its
> side effects????/????? here's a few more???????? ?? SOMEBODY PLEASE
> EXPLAIN.
> ...


Hi Mike,

I'm not sure there are no trials like that, but I think I
know why they are rare.

When you have a treatment that works, and the side effects
really aren't too bad, it's not considered ethical to
to give a trial treatment to someone that might not work
at all, or might not work as well as the standard treatment.

HT does work. It suppresses the cancer for a variable
period of time which can be a long time for some men. In
my personal view, the side effects are irritating, but
manageable. Some men suffer more with them, some less,
and some who do suffer more can get relief from other
treatments aimed at the side effects, or from self-help
through solid exercise and diet programs.

The sad fact is that the great majority of new drugs that
go into trials don't work, or don't work as well as HT.
That's why the newest treatments are usually given to men
only after they have failed HT. Once the treatments have
shown themselves to be successful, then they start getting
used at earlier stages in the disease.

Alas, there are other aspects to the whole problem as well.

When I was diagnosed with cancer and started researching
treatments, I was a little surprised to learn that what
seemed like an emergency to me didn't seem to affect other
people. My doctors didn't stop going on vacations or
going out to dinner. The researchers at the National
Institutes of Health didn't drop everything and come up
with a solution to my cancer. Brilliant young people
didn't cancel their plans to enter law school and go into
medical research instead. It was shocking!

Alan
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  #3  
Old 08-01-2008, 09:48 PM
Steve Jordan
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Posts: n/a
Default Re: My next step, Trials options.

On August 1, Alan Meyer wrote:

Quoting MikeHi

>> ....WHY THE **** ARE THERE NO TRIALS WHERE THE CONTROL IS THE
>> STANDARD HT AND THE TRIAL IS THE REPLACEMENT FOR THE HT and all its
>> side effects????/????? here's a few more???????? ?? SOMEBODY PLEASE
>> EXPLAIN. ...


Alan replied, in pertinent part:

> I'm not sure there are no trials like that, but I think I
> know why they are rare.


There are also trials with a built-in "crossover" feature. Thus: if the
experimental med appears to have excellent results, the cohort on the
placebo are moved over to the experimental med side.

I think it's something about which to inquire if contemplating entry
into a trial. I'm unsure of the details, just that there are crossover
provisions in at least some clinical trials.

Regards,

Steve J
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  #4  
Old 08-02-2008, 04:03 AM
Steve Kramer
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Posts: n/a
Default Re: My next step, Trials options.

<MikeHi@anon.com> wrote in message
news:gr2494l2sf5jkom2c8aii5p6jr0af3tpen@4ax.com...

> At 80 years of age but still suspiciously alive, my info sheet (me,
> not the info sheet, is old) reads: "It is expected it will take six to
> ten years to complete the study". H'mm.


Hell, I'd take that one at 53 years of age. I'd take anything that gave me
six to ten years!



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  #5  
Old 08-02-2008, 04:42 AM
J
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Posts: n/a
Default Re: My next step, Trials options.

MikeHi@anon.com wrote:

>
> I appear to qualify for only one trial - "Stampede". Briefly, I would
> have to take standard androgen suppression, plus a) any one of Zometa,
> Taxotere or Celecoxib, or b) plus a combination of Zometa with either
> Taxotere or Celecoxib. The aim is to assess which of the five combos
> could make AS benefits last longer. The computer allots at random.
> The control arm is standard AS (though we can agree what exactly with
> doc.). (It all sounds very kh'ish.)
>
> At 80 years of age but still suspiciously alive, my info sheet (me,
> not the info sheet, is old) reads: "It is expected it will take six to
> ten years to complete the study". H'mm.


http://www.cancerhelp.org.uk/trials/...p?trialno=6888
A trial looking at hormone therapy with zoledronic acid, docetaxel or
celecoxib for prostate cancer (STAMPEDE; MRC PR08)

Hormone therapy is often used to treat prostate cancer that has spread
outside the prostate gland. It can work very well, but the cancer often
starts to grow again at some stage. Doctors think that using other
treatments at the same time as hormone therapy may work better. But they
are not sure yet how well they will work.

Trial design

This is a randomised trial. The research team have completed the pilot
study, and are now recruiting a total of 3,300 men to the full trial. The
trial has 6 groups. The men taking part will be put into treatment groups
by a computer. Neither you nor your doctors will be able to decide which
group you are in.

All men taking part will have hormonal treatment. This could be hormone
injections, tablets or implants. Or an operation to remove both testicles
(an orchidectomy). The hormone testosterone is made the testicles, so if
they are removed, the level of testosterone falls dramatically. If you are
in group 1, you will not have any other treatment.

* Group 1 will have hormone therapy or an orchidectomy
* Group 2 will have hormone therapy or an orchidectomy, plus
zoledronic acid (zoledronate or Zometa)
* Group 3 will have hormone therapy or an orchidectomy, plus docetaxel
(Taxotere)
* Group 4 will have hormone therapy or an orchidectomy, plus celecoxib

* Group 5 will have hormone therapy or an orchidectomy, plus
zoledronic acid and docetaxel
* Group 6 will have hormone therapy or an orchidectomy, plus
zoledronic acid and celecoxib

If you are in group 2, 5 or 6, you will have zoledronic acid as an
injection into a vein once every 3 weeks for 18 weeks. Then once every 4
weeks for up to 2 years.

If you are in group 3 or 5 you will have docetaxel into a vein once every
3 weeks for 18 weeks. You will also take steroid tablets called
prednisolone every day during this time. If you are in group 5, you will
have zoledronic acid and docetaxel as separate injections on the same day,
every 3 weeks for the first 18 weeks. You then have zoledronic acid every
4 weeks for up to 2 years.

If you are in group 4 or 6 you will take celecoxib tablets twice a day for
up to year.

You will fill out a questionnaire when you start treatment, then again at
6 weeks, 3 months, 4 months, 6 months and 1 year. And then once a year
after that. The questionnaire will ask you how you are feeling and about
any side effects you have had. This is called a quality of life
questionnaire.


http://www.stampede.bham.ac.uk/
STAMPEDE
Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of
Drug Efficacy A multi-arm multi-stage randomised controlled trial (MAMS
RCT)

Background
A number of newer treatments have become available and have shown initial
promise against prostate cancer. Newer treatments are usually used in
prostate cancer when hormone treatment is no longer effective and the
cancer has started to grow again. An alternative approach would be to
investigate the use of experimental agents at an earlier stage, at the
time of initiating long term hormone therapy; patients would be fitter,
may be better able to tolerate them and there is the possibility of having
a larger effect.

Objectives
STAMPEDE is designed to assess the safety and efficacy of 3 very different
drugs for the treatment of locally advanced or metastatic prostate cancer.
These drugs are docetaxel (chemotherapy), zoledronic acid (bisphosphonate)
and celecoxib (cox-2-inhibitor) and are given in various combinations to
patients starting long-term hormone therapy.

The trial is divided into five phases – Pilot and Efficacy Stages 1-3 and
Efficacy Stage 4. The primary outcome measures are safety + feasibility,
failure-free survival and overall survival, respectively.

Trial Status
STAMPEDE’s Pilot phase is now open to recruitment at 20 chosen pilot
sites. The Pilot phase is estimated to recruit for 12-18 months, after
which we will open up recruitment to all other interested centres in the
UK and internationally

Patient Information
Study Investigators/Health Care Professionals Information

For general enquiries about the trial or website please e-mail

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  #6  
Old 08-02-2008, 09:47 AM
safire
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

Steve Kramer wrote:
> <MikeHi@anon.com> wrote in message
> news:gr2494l2sf5jkom2c8aii5p6jr0af3tpen@4ax.com...
>
>> At 80 years of age but still suspiciously alive, my info sheet (me,
>> not the info sheet, is old) reads: "It is expected it will take six to
>> ten years to complete the study". H'mm.

>
> Hell, I'd take that one at 53 years of age. I'd take anything that gave me
> six to ten years!
>



Learn to read. It doesn't say it'll give you six to ten years.

BTW: the average life expectancy of a Brit aged 80 is 86 years.
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  #7  
Old 08-02-2008, 11:25 AM
MikeHi@anon.com
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

In my post I had written:

>MikeHi@anon.com wrote:
>> ...
>> ....WHY THE **** ARE THERE NO TRIALS WHERE THE CONTROL IS THE
>> STANDARD HT AND THE TRIAL IS THE REPLACEMENT FOR THE HT and all its
>> side effects????/????? here's a few more???????? ?? SOMEBODY PLEASE
>> EXPLAIN.
>> ...


On Fri, 01 Aug 2008 16:16:42 -0400, Alan Meyer <ameyer2@yahoo.com>
wrote in his usual considered way:

>Hi Mike,
>
>I'm not sure there are no trials like that, but I think I
>know why they are rare.
>
>When you have a treatment that works, and the side effects
>really aren't too bad, it's not considered ethical to
>to give a trial treatment to someone that might not work
>at all, or might not work as well as the standard treatment.


But could that really be argued now about, e.g. abariderone, for
example? Not ethical?
>
>HT does work. /


Big Snip

Yup, agreed, and that's why despite my ******* I've concluded that I
will enter the trials.

>Alas, there are other aspects to the whole problem as well.
>
>When I was diagnosed with cancer and started researching
>treatments, I was a little surprised to learn that what
>seemed like an emergency to me didn't seem to affect other
>people. .....


more on same lines. concluding:

>..... Brilliant young people
>didn't cancel their plans to enter law school and go into
>medical research instead. It was shocking!


Honest Alan, I don't really expect the world to stop, either to let me
off, or concentrate on my problems. But, as a layman, I see an
inbalance between the new speeds of discoveries and the standard
systems of clinical trials.

As I commented in my adjacent post about the Australian trials
starting - the researchers there recognise there is a timing problem
between discovery, and getting new and better drugs to patients -
which they believe in their case they have overcome. That there is a
problem is also recognised by the new practice in the UK (don't know
about USA) of offering new drugs to terminally- ill patients with
nothing to lose.

And if a doc was to say to me, 'Look, ethically we can't offer you x
(maybe abariderone?) or y (maybe white cell immunotherapy?) and here
are the reasons why - including it may shorten your life, cf HT and
chemo - but are you willing to take it?,' and other docs asking the
same question of scores of others with bad prognostics ???

After all, in the standard trials I'm going for, they write that if
the drugs aren't working out, they will stop them.

Kind regards

Best wishes to all

MikeHi
"Exponential lightspeed". Def: The discovery of the cure for Pca at a
speed which defies Einstein.
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  #8  
Old 08-02-2008, 01:58 PM
Steve Kramer
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

"safire" <safire@telenet.com> wrote in message news:g70vfn$jr6$1@aioe.org...
> Steve Kramer wrote:
>> <MikeHi@anon.com> wrote in message
>> news:gr2494l2sf5jkom2c8aii5p6jr0af3tpen@4ax.com...
>>
>>> At 80 years of age but still suspiciously alive, my info sheet (me,
>>> not the info sheet, is old) reads: "It is expected it will take six to
>>> ten years to complete the study". H'mm.

>>
>> Hell, I'd take that one at 53 years of age. I'd take anything that gave
>> me six to ten years!
>>

> Learn to read. It doesn't say it'll give you six to ten years.
>
> BTW: the average life expectancy of a Brit aged 80 is 86 years.


Ha! Been having a problem with my Motzarella (or ISP). Tried doing some
things just to see if it helped. I emptied my kill file. And, just as I
do, my old friend Safire is there to greet me.

I apologize to you for the joke. I generally aim my humor at a level that a
person with and average intellect can grasp. You never had a chance. I
suggest you kill-file me. That way you won't have to beat yourself up
wondering why you don't get the next one.

BTW, in looking into my kill-file, I was reminded of another turd from many
years ago on this NG; a guy calling himself Wolfgang. His messages emanated
also from that oft-defeated country you apparently call home. Is it
possible (I know the odds are long) that you two are one in the same?


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  #9  
Old 08-02-2008, 03:29 PM
safire
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

Steve Kramer wrote:
oft-defeated country

wars SS-obersturmbannfuhrer's Kramer new country has lost:

Canada
Vietnam (because Kramer and his comrades weren't smart enough)
Somalia
Afghanistan
Iraq
Poverty
Drugs

But no, I don't live in the U.S.




>

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  #10  
Old 08-03-2008, 04:56 AM
J
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

Steve Kramer wrote:

> "safire" <safire@telenet.com> wrote in message news:g70vfn$jr6$1@aioe.org...
> > Steve Kramer wrote:
> >> <MikeHi@anon.com> wrote in message
> >> news:gr2494l2sf5jkom2c8aii5p6jr0af3tpen@4ax.com...
> >>
> >>> At 80 years of age but still suspiciously alive, my info sheet (me,
> >>> not the info sheet, is old) reads: "It is expected it will take six to
> >>> ten years to complete the study". H'mm.
> >>
> >> Hell, I'd take that one at 53 years of age. I'd take anything that gave
> >> me six to ten years!
> >>

> > Learn to read. It doesn't say it'll give you six to ten years.
> >
> > BTW: the average life expectancy of a Brit aged 80 is 86 years.

>
> I apologize to you for the joke. I generally aim my humor at a level that a
> person with and average intellect can grasp. You never had a chance. I
> suggest you kill-file me. That way you won't have to beat yourself up
> wondering why you don't get the next one.


That was not a heart-felt apology; Just an excuse to insult him.

J

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  #11  
Old 08-03-2008, 08:22 PM
Steve Kramer
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

"J" <xewsnswex@nalid;"no> wrote in message
news:4895275A.AB1ADE21@execulink.com...

>> I apologize to you for the joke. I generally aim my humor at a level
>> that a
>> person with and average intellect can grasp. You never had a chance. I
>> suggest you kill-file me. That way you won't have to beat yourself up
>> wondering why you don't get the next one.

>
> That was not a heart-felt apology; Just an excuse to insult him.


That is correct.


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  #12  
Old 08-04-2008, 09:00 PM
Alan Meyer
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

Steve Jordan wrote:
> ...
> There are also trials with a built-in "crossover" feature. Thus: if the
> experimental med appears to have excellent results, the cohort on the
> placebo are moved over to the experimental med side.
> ...


Yes. I've seen some trials descriptions that offer this.

Alan
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  #13  
Old 08-04-2008, 09:00 PM
Alan Meyer
Guest
 
Posts: n/a
Default Re: My next step, Trials options.

MikeHi@anon.com wrote:
> ...
> Honest Alan, I don't really expect the world to stop, either to let me
> off, or concentrate on my problems. But, as a layman, I see an
> inbalance between the new speeds of discoveries and the standard
> systems of clinical trials.


I understand Mike. I didn't mean it as a personal comment,
just that all of us who have seen the grim reaper in our
path acquire a different outlook.

> As I commented in my adjacent post about the Australian trials
> starting - the researchers there recognise there is a timing problem
> between discovery, and getting new and better drugs to patients -
> which they believe in their case they have overcome. That there is a
> problem is also recognised by the new practice in the UK (don't know
> about USA) of offering new drugs to terminally- ill patients with
> nothing to lose.
>
> And if a doc was to say to me, 'Look, ethically we can't offer you x
> (maybe abariderone?) or y (maybe white cell immunotherapy?) and here
> are the reasons why - including it may shorten your life, cf HT and
> chemo - but are you willing to take it?,' and other docs asking the
> same question of scores of others with bad prognostics ???
>
> After all, in the standard trials I'm going for, they write that if
> the drugs aren't working out, they will stop them.

....

I don't have a settled answer to your point. I think you
might be right. I also think you might be wrong. I just
don't know. There was an article about this recently in
the Sept. 2007 issue of _Scientific American_. Your local
public library may have it (mine did).

Strong arguments were presented on each side. The arguments
for your point of view were made even stronger by parents of
a 21 year old girl who died of a disease when an experimental
drug _might_ have saved her.

It's worth noting however that, here in the U.S., there are
laws that permit dying patients to get experimental drugs
under some circumstances, yet they're still hard to get. The
makers of the drugs have no interest in distributing them
before the trials are complete, and are under no legal
obligation to do so.

Remember, GlaxoSmithKline, Merck, Pfizer, AstraZeneca, and the
rest of them aren't in business to cure disease. They're in
business to make money. If they can make more money from an
impotence drug, or a wrinkle cream, than they can from a
cancer cure, guess which one they'll invest more money in.
I'm not saying that's right or wrong, I'm just saying that's
the way it is. I personally like to think that the work I
do helps people, but I have to admit that if I wasn't paid
to do it I'd almost certainly go into another line of work.

There's really no incentive for drug companies to give a drug
to people outside of a trial. If people taking their drug
die, and weren't under strictly controlled trials conditions,
what impact will that have on the company? It can't be
positive.

So we're not dealing with a strictly legislative problem
here.

Alan
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