PARP vs Doxil Clinical Trial

Hello beautiful girls.

I'm Sue and I'm from Australia. I've been visiting the forum on and off since about November last year but I've finally decided to post! I love visiting this site and listening to all your stories and I realize I'm not alone. I am encouraged by all your testimonies and I love reading all your posts.

As you can see from my profile, I was dx with OC stage 3C in March 06. Since Oct 08 I have been enrolled in a Clinical Trial comparing PARP inhibitors and Doxil.

I have the BRCA1 mutation.

Well, I was assigned to the Doxil arm (IV chemo every month). I was extremely disappointed and depressed as I wanted the PARP inhibitors because I was sick of needles and wanted the tablets instead!!

Has anyone else been on the trial, or on the trial right now (whether receiving PARP tablets or Doxil)??? Furthermore, has anyone actually switched over from the Doxil to the PARP drugs... I think it's gonna be a battle switching over to the tablets since there's this horrible requirement for tumors to have increased by 20% in order to classify as progressive disease to switch over to the other drugs. As for me, I've had 4 doses/cycles of the Doxil since October and it appears that my CA125 is rising again and that the disease is progressing. My CA125 has gone from 550 to over 1,000 after remaining at 400-500 for a couple of months. A CT scan last week showed a small increase in the size of a tumor in my lower abdomen. (I have a number of nodes/tumors in my lower abdominal cavity).

My heart is heavy for us women who are on clinical trials, fighting for life saving drugs that may help but we are prevented from trying them because of big pharma requirements and bureaucracy. I especially feel sorry for women who are on placebo drugs and they don't even know if they're getting the drugs they need.

Anywho, sorry to carry on like this, but I was just wondering if there are any others on this clinical trial I'm on... or anybody with any problems trying to get onto clinical trials, etc.

Love and God bless you all,

Sue

By Mish_E
Posted January 31, 2009 at 12:46 am
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Hi Sue,

I too are on the Parp trial and I am also Aussie. I am from Melbourne and I started the parp trial Dec 08. It was not easy getting on to the trial. They had very narrow parameters. Ironically, to get onto the trial that I hope will add years to my life, I had have a come out of remission (which I was in for about a month), then once I had a scan wait a month to see if the disease had progressed further. Luckily and unluckily it had!! But only "just" enough to get into the trial...

They say there will not know a result for three months but they have slipped in a CA125 test and it is on the way down. So so far so good. There are no placebo's on the trial I am in, the control group is the Doxil group. I was glad to know that they were not going to quietly watch you die while not getting treated at all!!

So, which part of Oz are you from? Are they going to switch you on to the Parpy if Doxil is not working?

Mish

By viki
Posted January 31, 2009 at 1:49 am
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I am an Israeli, they have the same trial running here and I am trying to get in. The results of the several women who are getting Parp-inhibitor seem to be really good, CA125 went down in most - and in the worst case - one disease stabilization. As one of you notes - instead of just giving it to as many women as possible they give it only via those trials, to a limited number of women who qualify stringent criterions..

By sueoz
Posted January 31, 2009 at 2:32 am
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Hi Mish,

Great to hear somebody whose on the trial in Australia. I'm from Sydney (at North Sydney). I would love to keep in touch with you to see how you are going on this.

Feel free to email me at suebogdan@yahoo.com and, if you like, we can chat on the phone.

And as with anybody else, whether in Australia or overseas, do the same as I love to chat on the phone with other women who are going through this awful disease so that we can support each other and get through this together.

Peace!

By Terrafly
Posted January 31, 2009 at 6:37 am
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Hi Sue

Im start on the the parp (iv) mon 9th after waiting for my tumour in my aortic lymph node to show up on the scan (it was 1.7 cm on 29/12).....My onco nurse said she's never seen anyone wanting to see disease return like i was lol.

As it gets nearer I'm feeling more nervous wondering if it will work for me, so Viki and Mish, your words are really encouraging :).

I havent had doxil yet but was thinking of it for an alternative if I dont respond to the PARP drug, 1 thing at a time huh ;). Thank goodness this is a trial where everyone on it gets the drug!....before i threw my dummy out the pram they were going to put me onto the icon6 trial, but i was horrified by possibly being put in the placebo group, and said that i would only be willing to do that as a last resort.

I really admire anyone who does take part in this trials but i wish the trial designers would try and do the trials differently as I think the 'placebo' thing seems really cruel to me, and am not convinced it is always necessary .

Anyway.......I hope we can support each other :)

Anita

By JanP
Posted January 31, 2009 at 6:25 pm
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Dear Sue and others on this trial'
Thanks for raising this trial. I am being considered for it but as I am feeling well at the moment despite rising CA I am very nervous about it. I really do not want to be in the Doxil arm and I am horrified to hear you have to stay on Doxil until you have a 20% rise in tumour size before you can move to the AZD 2281 tablets.

Of course Sue you could always leave the trial if you are really worried, but then what?

Anita I was going to pm you tomorrow re yr trial. Is it all AzD tablets or what is the other arm? How large to your tumours have to be? or is getting larger since last scan, sufficient? When does yours close?

Are there any ppl in US on this trial?
Viki, thank you for sending details re surgery for tumours. I'm still investigating that.
Do hope you can find some good treatment. Israel does seem very advanced in research.

Did you all see the post a few days ago re prozac enhancing chemo's effectiveness? I am very tempted to have caelyx away from a trial and get prozac from my GP.

Keep in touch buddies. Continue to share our knowledge.
JanP

By sueoz
Posted January 31, 2009 at 11:44 pm
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Hi Anita and JanP,

Thanks for your replies.

Anita, I never realized that the PARP-inhibitors were given as an IV treatment. The international trial that I'm on (which I'm assuming we all are on) is comparing 3 groups of people: the first and second are getting 2 different doses of PARP-inhibitors orally (200mg twice daily or 400mg twice daily ) and the third group is on the IV Doxil monthly.

For more, see http://www.clinicaltrials.gov/ct2/show/NCT00628251?term=ovarian+cancer+AND+ PARP&rank=6

My consent form says there will be "approximately 90 patients like you in approximately 31 centres in 9 countries).

Anita, is this the same clinical trial you're on as well? I think I remember reading that you were going to be getting IV Parp daily and that you were going to have a port put in (not looking forward to that myself, since my veins are giving up on me and I'm trying to delay that as much as possible).

Anita, you're exactly the same as me... my nurse was also bewildered that I was almost wanting my disease to progress so that I could get PARP tablets. At this point, I'm not likely to be able to switch over to them.

Keep in touch and continue with the posts my BRCA sisters.

Sue

By Mish_E
Posted February 1, 2009 at 5:45 am
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I think I was the only person the Familial Clinic had seen who was happy I had a BRCA1 mutation so I could get on the trial! It was quiet funny ..

By Terrafly
Posted February 1, 2009 at 6:54 am
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Hi all

Heyy Jan...Yeah feel free to pm me anytime :), that goes for all of you on this thread, you are all on my friends list x.

Yes my trial is open end so everyone on this trial receives the drug (AG014699) as a single agent, you can find all the details on the cancer research uk site (trial 10 under clinical trials for ovarian cancer).

It closes in Dec 09 and is multicentre, the only 2 i know off hand are at Newcastle and UCLH but am sure other centres are listed.

Im having a port fitted on Thursday and then the following Monday i begin by receiving a 30 minute infusion of AG014699 which i will get everyday for 5 days, then this repeats every 21 days, so no pills for me sue

The criteria asks for 'measurable disease' on the scan and so i take that to be anything the radiologist can pick up on the ct. Hope this is helpful :)

Jan I havent seen the multi arm trial they are talking to you about so am interested to know.

Mish I hope I respond to it as well as you have so far so am keeping everything crossed ;)......Prof Lederman has told me not all women respond and they are trying to figure out why.

Love and hugs to you all

Anita

xXx

By Terrafly
Posted February 1, 2009 at 8:19 am
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OMG you are all probably so sick of me lol !

Just had to share this link....it makes for very interesting reading :

http://www.medhelp.org/posts/show/514624

Promise i wont post for at least another few hours lol

xXx

By dollycat6
Posted February 1, 2009 at 10:34 am
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I love your responses Terrafly so don't feel "bad" remembering something you forgot to put in it could be pertinent to one of us out here!

dollycat6

By JanP
Posted February 1, 2009 at 3:06 pm
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I am delighted to see all your posts however often!!

The trial Sueoz and others are talking of is the one with 3 arms. One has IV caelyx. No 2 has 200mg tablets of atz 2281 . No. 3 has 400 mg tablets of atz 2281. It is the trial that is mentioned in your link. [Sorry the numbers may not be exactly correct]
They are doing it at the Royal Marsden London. Closing date very soon.

I am much more interested in your trial of a very similar PARP drug where everyone gets some version of the Parp drug even if it is IV. Am going to google it now especially cos it may be available in Manchester- my usual hospital. My consultant keeps very quiet about trials. Like you Anita we have had to search all this ourselves.
You would think a hosp would love you to go on a trial as all the expenses are borne by the drug companies!!

That link you put led me to another which suggested that the most successful outcomes were with patients who had not had many previous different chemos.

They seem very reluctant in GB to put people on maintenance. I am beginning to wonder whether that is because of cost implications!! What is the situation re maintenance in Oz?
Keep posting the info girls. We'll beat the system too if we have to.
JanP

By KellyRilla
Posted February 1, 2009 at 7:33 pm
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My counts just went up to the 600's and climbing. The PARP trial was mentioned as maybe something we would try since I'm BRCA1. I really don't know too much about it. The one I read about was a phase I trial. Not really what I would like. Phase II sounds good to me.

By Brandi
Posted February 2, 2009 at 12:27 am
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I want to tell all of you ladies that I am hoping for very good things for you. I am in the US. I am Ov IIIC BRCA 1 + and am hoping that I am still in remission. I finished treatment in May 2008 but my last CA-125 was increased over the prior one. I have been looking into PARP trials too in the event that I need more treatment. Thank you for sharing your information and experience. My heart goes out to all fighting the fight.

By Terrafly
Posted February 2, 2009 at 2:22 pm
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Heyy all :)

thanx Dollycat i needed that reassurrance lol, im just sharing any info i can get coz you never know, if it helps just 1 person then i know im doing the right thing ;D

Jan Im gonna pm you soon, bear with me coz I have a busy week on with appts at hospital and stuff but will get there :)

As you've prob gathered some of the info i've put up is for the UK but have a look at these links for one that I hope is nearer to you in the US :)

http://www.biparsciences.com/000013.html

and

http://www.clinicaltrials.gov/ct2/results?term=bsi-201

See ya soon evryone........will keep updating and hope to hear from you all soon with your updates :)

Anita
xXx

By Farah
Posted February 2, 2009 at 2:58 pm
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Dear JanP and others,

Is the PARP inhibitor only for Braca 1 and 2 women? I don't have either, and I'm looking for a clinical trial that does not include Avastin. Anyone know of any promising trials on the US eastcoast?

As always, thank you all.

Farah

By sueoz
Posted February 2, 2009 at 8:11 pm
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Hi everyone,

Great to see there are so many of us who are watching this space. Anita I really love your posts, keep them coming and dont think twice about posting as many posts as you'd like because I certainly learn lots from them, as we all do. I really wish you all the best with your PARP trial and pray that it keeps you in a very long remission or dare I say it, cures you and all of us who are trying to get onto them now or in the future!! I've learnt so much from all you sisters... I can't thank you enough.

JanP, in Australia, I dont think it's protocol to put us onto maintenance therapy if we are considered to be in remission though I have come across some breast cancer women on maintenance... but not ovarian. I think many doctors are against maintenance (apart from the obvious costs, chemo doesnt come cheap as you've said) because they dont want us to develop allergies to the drugs (like I did with carboplatin the second time around) or even resistance, not to mention that staying on chemo without really needing it only lowers our immunity.

KellyRilla sorry I haven't responded to you. Great to hear from you! The trial I'm on is Phase II. There are a number of PARP trials going on as Anita (Terrafly) and JanP have posted, many of which are also taking place in the US though I dont know if close to where you live.

As for me, my clinical trials nurse told me yesterday that the latest scan I had which showed a "slight" increase in the size of a lymph node/ lower abdominal cavity tumor wasn't "enough" for me to switch over at this stage to the PARP tablets which has annoyed me. As I've posted before, there's this RECIST criteria that says that either existing tumors must have increased 20% or new tumors must have popped up (as long as they're not ones to disqualify you from the trial) in order to switch over to the PARP drugs if you were originally assigned to the Doxil arm like I was. It's only a matter of time that I am, of course, because my CA125 keeps on increasing.. I'm now over 1,000 (from mid 500s last month). Having a scan done next week... I wonder what this one will show.

Until next time, love you all and you're all in my prayers.

Sue

By Terrafly
Posted February 6, 2009 at 8:51 am
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Hi all :)

Im feeling a little deflated today after a busy week of very early mornings and numerous hospital visits. Have got there in the end though and it was nice to find out that i do have a heart after all LOL. My port is now fitted and im all ready to start treatment on Monday.

Im feeling a bit deflated because......I didnt see the prof today, i saw the nurse and a registrar, my scan results werent ready and i forgot to ask about my CA125 count. Also I have found that there are many mutations of the brca1 gene (im heterozygous for the brca1 mutation - c.3756_3759delGTCT) and have read conflicting information from research studies.

One paper says that heterozygous brca1 mutations benefit from PARP inhibition and a few others say that heterozygous brca1 mutant carriers show no increased sensitivity to PARP1 inhibitors. I asked about this at my appt but they didnt know either.

I know i read too much and am gonna just have to wait and see (which really feels sucky right now :)

Maybe some of you know your particular mutation, I would love to know what they are :)

Anyways, At least I've got the weekend to relax before i have to trapse (dunno if thats a real word lol) down to London everyday next week.

Heres hoping the snow has cleared up and the schools stay open :D

love you all

Anita

xXx

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