Hello,
I was recently approved to participate in the Phase III trial. I am wondering if anyone has participated in the Phase II trial and what their experience has been.
Also, do you think participation may exclude me from future treatments?
clinicaltrials.gov/ct2/show...
Thank you.
Hi, I don’t know this trial but what I can say is that I have participated in 3 drug trials and it’s never stopped me from having treatment. Good luck x
I am also in a trial for Oregovomab with a 50/50 chance I am getting the actual drug. Are you noticing anything on the cycles that you may be getting the trial drug?
No, I didn't notice anything. I had a good overall response and my CA-125 steadily went down with each cycle but the percent decrease got smaller with each cycle. The cycles in which I was getting either the placebo or oregovomab did not cause my CA-125 to drop by a larger percent decrease.
I did get my tumor test results back mid-chemo and switched doctors. My new doctor wanted me on Avastin for my last two cycles and then go on maintenance Avastin/Lynparza for maintenance since my tumor tested positive for a brca1 mutation.
I do hope the trial works for you. I hope that I was getting oregovomab too while I was on it. The results of the phase 2 trial were incredible. Best of luck to you.
Thanks for your reply! So did you drop out of the trial as per your new doctor’s recommendation and if so would you mind sharing his or her rationale to do so? Decisions, decisions…..
Yes because my tumor tested positive for the brca 1 mutation and she wants me to follow the protocol of the previous Paola-1 trial (avastin w/ chemo and the avastin with lynparza for maintenance after chemo).
Once I switched and started receiving Avastin (between 4th and 5th cycle) my Ca-125 dropped by a larger percent (which I hadn’t experienced before) drop than the previous cycles so I’m happy with the progress. My Ca-125 was very high , 3,800 at diagnosis, and only dropped to 1,400 after surgery even though I was optimally debulked. Then it dropped to 350 after my first chemo. It’s currently at 23. The doctor who did my surgery didn’t think I needed avastin because I was optimally debulked but looking back I wish I had it. I also received two other second opinions (John Hopkins and Md Mercy Baltimore) that said Avastin wasn’t a must. My new doctor says she gives Avastin for stage 3 and 4 high grade serous with chemo.
However, there are other things you may want to consider such as overall survival or progression free survival results for phase 2 Flora-5 trial versus previous trials with avastin.
Ok Thanks. So the tumor tested positive for BRAC 1 even though the genetic testing was negative for BRAC? I’m assuming that because the trial requires negative BRAC 1 and 2 to get into the trial. I’m still trying to learn.
Have you had your tumor tested yet?
Even after i found out that I had the brca mutation in my tumor I stayed on the trial for two cycles. The clinical investigator didn’t even mention it even though it’s listed as an exclusion criteria.
I noticed that the trial I was on is now no longer recruiting (NCT04498117). There is another trial for oregovomab with neoadjuvant chemotherapy (NCT05605535) and I don’t see brca listed as an exclusion criteria.
I would get your tumor tested and also talk to your gyne oncologist to see what their recommendations are. There are other clinical trials that look good for frontline (sometimes you have to join the trial before you even have surgery). Many of these trials have 2-3 week screening periods too. It is a lot to manage right after diagnosis and surgery.
Thank you for all your good information. Good luck to you!
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