OVATURE Trial

• By zircons
• Posted March 14, 2009 at 6:38 pm
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What is the Ovature trial? Chemo?

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• By tex2step
• Posted March 14, 2009 at 10:23 pm
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Here is some information on the OVATURE Trial.
I hope that this helps......
A new clinical research study called OVATURE (OVArian TUmor REsponse) is underway in the U.S., Europe and Australia. Patients in the trial will receive an experimental treatment regimen consisting of weekly carboplatin. Half of the patients in the trial will also receive the investigational drug phenoxodiol. The other half will receive a placebo so that neither researchers nor patients can tell which arm of the trial the patient is in.

All patients on the trial will be receiving therapy that researchers hope may be helpful. This is because a change from an every third week to a weekly carboplatin regimen has been reported to provide tumor response in some heavily pre-treated patients with recurrent ovarian cancer.1 In addition to learning more about the efficacy of phenoxodiol, researchers will learn more about the efficacy of weekly carboplatin.

Patients may also access more information on the OVATURE trial through www.clinicaltrials.gov (type OVATURE in the search box).

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• By aquilega
• Posted March 15, 2009 at 7:51 am
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I have been on this trial for over four months but have not really come across anybody else who is also on the trial.

Recruitment has been going on for sometime now across the world including quite a number of hospitals in the US and consequently had hoped that somebody on this site would also be on the trial.

The eligibility for the trial is quite strict which can make it difficult, nevertheless I would recommend it to anybody who is facing a relapse less than six months after a carbo/taxol type treatment.

Aquilegia

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• By JanP
• Posted March 15, 2009 at 6:49 pm
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I agree. i think it is an excellent trial but as you say it is extremely difficult to meet the criteria.
I tried to get on it. I started looking for it on Dec 22nd Unfortunately I made the big mistake of having a scan on Jan 6th which did not include the lungs/chest. Here in GB you cannot get a further scan within a month and the requirement of being no more than 6months from previous platinum therapy expired on Feb 8th

A scan on Feb 17th showed that I would have actually qualified.

So if you want to do it. Be very careful and watch out for dates!!!

I have a friend who is doing very well on it. I know she looks here sometimes so she may reply herself.
JanP

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• By Aqua
• Posted April 3, 2009 at 3:43 am
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aquilega,

I'm glad you are doing well in the OVATURE trial - there is an excellent chance you are in the phenoxodiol arm.

I have followed phenoxodiol for many years. Your oncologist might be interested by a recent paper written by Professor Morre of Purdue University, which says in part:

"A particularly striking example of chemosensitization is that encountered with the synthetic isoflavene phenoxodiol where patients with taxane- and/or platinum-resistant ovarian carcinoma once again become sensitive to these drugs following treatment with phenoxodiol. The latter appears to be a true chemosensitization in that the phenoxodiol need not be co-administered with the taxane or platinum drugs. Sensitivity is retained many weeks after the phenoxodiol has been cleared from the system".

http://www.scipub.org/fulltext/AJPT/AJPT3119-29.pdf

In plain English, this means that any cancer cells that remain after phenoxodiol/carboplatin treatment is finished may be sensitive (again) to taxane treatment, even though phenoxodiol is no longer being used.

This is not just an abstract concept - it has already happened in the clinic.

http://www.marshalledwardsinc.com/index04.cfm?id=158&section=04&status=2

"Following completion of the phenoxodiol therapy because of disease progression, a number of the patients were re-challenged with standard chemotoxic drugs in order to test what effect phenoxodiol therapy had on their sensitivity to standard anti-cancer drugs. Because all patients had recurrent disease despite being heavily treated with chemotherapy, a clinical response to further chemotherapy was considered unlikely.

In 10 patients who received paclitaxel, 8 of the 10 responded with an immediate and marked decline (average 64%) in their CA125 levels; the other 2 women failed to respond and showed progressive disease. Five of the 10 women treated with paclitaxel were previously considered either resistant or refractory to paclitaxel (that is, their disease previously either had recurred within 6 months of paclitaxel therapy, or continued to worsen despite paclitaxel therapy). However, after treatment with phenoxodiol and subsequent treatment with paclitaxel, 4 of these 5 patients showed a marked response in their CA125 levels, and 3 remain alive after an average of 292 days."


If you raise this issue with your oncologist now, s/he would have time to contact Professor Morre to clear up any points. Just a thought...

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• By momanderson920
• Posted June 19, 2009 at 5:31 am
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I am having a recurrence after 11 months since my last chemo of taxol/carboplatinum. I have serous papillary epithelial ovarian cancer. I am most interested in the Ovature trial. I would like to know the criteria for eligibility as well as how it works, side effects, etc. Also where you are receiving it. Thanks for sharing as I feel I have to act quickly as I am experiencing pain and figure that means the cancer is coming back fast. Thanks again!

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• By momanderson920
• Posted June 19, 2009 at 5:32 am
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Oh, almost forgot...I was diagnosed Stage III3C

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• By JanP
• Posted June 20, 2009 at 3:15 pm
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Hi

You must have a measurable tumour of at least 1 cm.
You must start on the ovature trial within 6 months of your previous chemo.
I think it is more than 6 months since your last chemo?

Both these requirements are very difficult to fulfill. Also I am almost sure that the trial is now closed. Certainly in UK but not sure about USA.

It is a very good trial and if you don't qualify then keep your eyes open for the drug coming into main line chemos. That is what I am doing having failed to get on the trial last February.

Best wishes JanP

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• By Shearaw
• Posted June 20, 2009 at 4:07 pm
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I think that the company sponsoring the OVATURE trial has decided to stop recruiting, and focus on its newer trials. I think that the newer trials might be run at Yale in the US.

Sheara

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• By aquilega
• Posted June 21, 2009 at 12:32 pm
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Hi Momanderson

I am so sorry to hear of the return of your symptoms. Have you had a scan yet to check what is actually happening?

Like others have said the OVATURE trial is now closed and therefore no new patients can be taken on. They will be announcing the results of their initial analysis in the next few months, and then I would imagine that if it looked good then they would hope that the drug could be granted a licence. However only 141 people were on the trial and that may be considered to few to draw any firm conclusions.

I do hope that there are some other options that your oncologist can suggest for you.

With very best wishes

Aquilega

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• By momanderson920
• Posted June 21, 2009 at 1:18 pm
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That is ashamed that they may not be able to license it as it sounds like it had great success. If you hear anything on it, keep me posted. Thanks, Cindy

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• By aquilega
• Posted June 21, 2009 at 1:24 pm
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Of course, from what I can see the drug phenoxodial shows great promise, and what is more it seems to reduce the side-effects of the regular chemo drugs which is brilliant.

Much love to you Cindy

Liz xxx

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