OVATURE Clinical Trial Recruiting in the US

[jthmpsn]

I could not find any contact information for a moderator of MedHelp. I don’t usually post this information myself, so if someone is in charge and reading, please email me so I can coordinate with you in the future.  My address is below.

I’m writing to inform ovarian cancer patients about a Phase III clinical trial for women with recurrent ovarian cancer called “OVATURE,” which stands for OVArian TUmor REsponse.  I work on behalf of the sponsor of the trial, the biotech company Marshall Edwards, Inc.  

Our new website, www.OVATUREtrial.com is designed to help ovarian cancer patients seeking information about the OVATURE trial.  The website includes a page dedicated to answering patients’ questions, and a page to locate trial sites.

The trial seeks to recruit 235 women in the US and a total of 470 women globally.  All patients on the trial will receive carboplatin weekly, in doses lower than that given when carboplatin is administered in the more typical once every three or four week dosing regimen.  A change from receiving carboplatin (or cisplatin) every two to three weeks to a weekly carboplatin regimen has been reported to provide a tumor response in some patients with recurrent ovarian cancer.*  In addition to learning more about the efficacy of phenoxodiol, researchers will learn more about the efficacy of weekly carboplatin.

If you have additional questions, you are welcome to email them to me at ***@**** and I will do the best I can to get the questions answered in a timely manner.  Thank you.


* Piura B and Meirovitz M.  Weekly single-agent carboplatin in heavily pretreated patients with recurrent ovarian, peritoneal and fallopian tube carcinoma.  Eur J Gynaecol Oncol. 2005;26(4):386-90.

[Diane B]

I was on Carbo/Taxol as my first line treatment back in 2003 then I was in remission for 18 months which I did Carbo/Taxol again but weekly for three treatments which put me back in remission for 4 months.  Then the spring of 2006 it came back again so I did 4 rounds of Doxil and it didn't do anything.  Then I did 2 rounds of Topoteacan before that stopped working.  Then of course I did weekly Taxol and I did 1 rounds of weekly Carbo then was added Taxotere.  So today I start Avastin and Cytoxan.  I just hope this will keep working for a long time.  

Alan, I hope your Mother does well on Doxil.  

Thanks, Diane

[Kimchi]

I have been on taxol/carbo every month for 10 months (had a 7 weeks break between 9 and 10 due to scheduling of ct scan, dr.,next chemo).  Think I might be developing some kind of reaction although once I asked that the speed of the drip be slowed down, things went back to usual.I am  scheduled for 2 more treatments than another scan. Yesterday my 3 inch long hair started to shed due to that 7 week break!!! back to the turbans!

[alanpvegas]

I think Carbo/Taxol, as a combination, is only given during first line treatment...it is rarely given as a combination again.  This is due to the cancer learning to protect itself against that treatment. Evolving, if you will, to protect itself by coating itself with a substance (I forget exactly what).

There is nothing against doing weekly Carbo or weekly Taxol.  Both have shown effectiveness.  My mom's oncologist is stopping her weekly taxol and we are now going to Doxil because the counts are too high again.

[Diane B]

Thanks Alan,  I wonder how many time you can do Carbo/Taxol.  I did the combination twice and then I did weekly Taxol which only worked for about eight weeks.  Doxil along didn't work for me but maybe the combo would.  Thanks for other options.  I really wish and pray they come up with something much better real soon.  

How is your Mother doing?

Thanks again,  Diane

[alanpvegas]

Oh and here is another benefit, recent study shows it can even be used to prevent neuropathy:

http://www.alanpeto.com/ovarian_cancer/blogs/72/Newly-Published-Research-Indicates-the-Potential-of-Phenoxodiol-to-Protect-Against-Neuropathy.html

It's the little pill that can... :)

[alanpvegas]

Hi Diane,

Marsall Edwards (the pharm company) has as part of the Phase III Phenoxodiol trial two arms with one being the drug (Phenoxodiol) and weekly carbo or a placebo and weekly carbo.  A study (I think back in 2001) showed that weekly carbo can produce an effect even in platinum resistant ovarian cancer.  It's impressive that they are doing this instead of just doing a placebo and that's it.  I think it shows that not all Pharm companies are alike and the trend to actually helping the patients in clinical trials (esp Phase III) is important.

Phenoxodiol is an analog of the soy isoflavone Genistein.  Genistein has alway shown anti-cancer activity, mostly by chemosensitizing platinum resistant ovarian cancer cells.  Marshall Edwards and Novogen (I hope I'm spelling that company name right), turned Genistein into a more targeted version and call it Phenoxodiol.  It is given in tablet form.  While it can be used as monotherapy (alone), it's always been promoted with use with a chemotherapy agent (such as carbo).  

Here is more info on my site about Genistein:  
http://www.alanpeto.com/ovarian_cancer/articles/6/1/Genisteinthe-cure-for-platinum-resistance/Page1.html

Now here is the neat stuff:  It works with lots of cancers...but ovarian is giving them fast track status (not fast enough though).  It can work before the cells become resistant...yet that won't get them fast track status, they need to do it this way.  So in the future, this may be given along with Taxol/Carbo.  Imagine that...your first line chemo along with Phenoxodiol....imagine the possible success rates?  :)  Now imagine the FDA holding this up again.  :(   It needs to be given the status Taxol was given in the 90's where it could be prescribed outside of the trial while in Phase III.  Period.

So, this is the best one coming out so far but they just started PHase III this year...too long a wait for the majority of people, especially my mom.  The other one to look at is combinations (if you can tolerate it) such as Doxil and Eloxatin (more info:  http://www.alanpeto.com/ovarian_cancer/blogs/69/DoxilEloxatin-May-Provide-a-Treatment-Option-in-Advanced-Recurrent-Ovarian-Cancer.html )

[Diane B]

Alan,

I am not sure I understand this because my cancer center at Lankenau Hopsital is doing a weekly carboplatin regimen not sure what dose.  But it didn't work for me so we added taxotere to the regimen and it worked great for 12 weeks before the cancer started spreading again.  Tomorrow I start avastin and cytoxan in hope it will work a lot longer then the carbo/taxotere.  Do you know of any new drugs coming out, I just feel I need to start looking for my next options when this one doesn't work anymore.

Thanks Diane

[alanpvegas]

Marshall Edwards needs to do what 'Taxol' did before it was approved.  They got approval from the FDA to sell the drug despite it still being in Phase III trials.  This meant even those not in the trial could still get the drug.  I have no clue why they haven't done this...fast track status is anything but with the FDA.  What, something like 10,000 women will die while this drug is in Phase III trials...heck it's just starting recruitment.  We can't wait that long.

[freshair]

Too bad. I would have liked to be in this trial. I found out through the website that I can't because I am on Carboplatin/Taxotere now. I have had it 3 times. Once every 3 weeks. I live in Long Island and could have easily driven up to Yale.

[jthmpsn]

Great. Thanks Alan. People are welcome to send questions to:
info -at- ovaturetrial.com

[alanpvegas]

You can put your email in this format:

myemail  -at- somewhere.com

[jthmpsn]

I just noticed that my email address isn't allowed to be posted so I'll be monitoring the forum periodically to check for questions or comments.

[alanpvegas]

This is the Phenoxodiol trial everyone ;)  Get on this train if you qualify!  It needs to go to market right now IMHO.