Anyone participating in the ATHENA clinical trial?
I've recently completed first-line chemo for stage 3b carcinosarcoma, and was looking for anything that might reduce or delay recurrence. I am BRCA-negative, so a PARP inhibitor may not be of any benefit to me. My gyne-onc referred me to the Princess Margaret Cancer Centre in Toronto and they suggested that I might be eligible to participate in the phase 3 ATHENA trial. It's a bit complicated, but basically this trial is a 4-arm double-blinded trial of a combination of rucaparib (a PARP inhibitor) and nivolumab (immunotherapy - a checkpoint inhibitor).
The process seems to be quite onerous - they tell me I would have to stay in the Toronto area (I live in Ottawa) for the first couple of months of treatment, and then would have to go there for up to 3 nights every month for about 2 years. There are many potential side effects, some of which have very low probability of occurring but very high consequence if they do - things like heart inflammation, brain inflammation, kidney failure, etc. And of course, there's a chance of being in the placebo group and going through all the hassle for nothing.
I have to make a decision really soon, and I'd love to hear if anyone else is in this trial or has considered it.
The process seems to be quite onerous - they tell me I would have to stay in the Toronto area (I live in Ottawa) for the first couple of months of treatment, and then would have to go there for up to 3 nights every month for about 2 years. There are many potential side effects, some of which have very low probability of occurring but very high consequence if they do - things like heart inflammation, brain inflammation, kidney failure, etc. And of course, there's a chance of being in the placebo group and going through all the hassle for nothing.
I have to make a decision really soon, and I'd love to hear if anyone else is in this trial or has considered it.
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I guess there aren't a lot of OVdialogue folks in the ATHENA trial. I thought I'd post an update on my decision, just in case someone else searches for conversations on this trial.
The doc at the PM in Toronto was quite discouraging and scary - she went on at great length about the possible dangers of the clinical trial drugs, how they can cause permanent changes to the body, like heart or kidney damage, and how if that were to happen they wouldn't be able to treat me with chemo if my cancer recurred. She didn't talk about how the study might benefit me at all. Since I would have to start the trial before the site in my hometown (Ottawa) was up and running, I had been told by my gyne-onc I could easily transfer from the PM to The Ottawa Hospital later. But the doc at PM said that transferring my participation to a different site would be very difficult and maybe impossible. I know they have to go over the potential risks, but I almost felt she was discouraging me from participating in the study. I said that to the nurse afterwards, and she agreed.
Yesterday I had an appointment with the doctor who's the site lead at the Ottawa Hospital, just to get her perspective on what the doc at PM had to say. They had a big surprise for me - the Ottawa site officially opened that day! I had been told they would be opening in February/March, too late for my start deadline. This news takes away a huge burden around the logistics of participating and having to be in another city, and leaves only issues of potential risks and benefits. The doc here talked about the risks too, but emphasized how closely they would be monitoring me for side effects, and reminded me that my type of ovarian cancer is much more aggressive than "standard" oc is and much more likely to recur sooner, and that this study is trying to prevent or delay recurrence.
So, after a pretty sleepless night, I called them this morning to say I'm in. We still have the timing issues with the tissues sent to the lab in the USA and other screening test results having to be in on time, but if that works out, I will be starting in the trial by the end of this month and continuing on for 25 months if all goes well.
Yes, that is the one great part of being in a trial is that you are closely monitored. (my guess/understanding is that you could choose to leave the trial at anytime and make other choices best for you on continued care or alternatives).
Hoping you are feeling well this week and wishing you the very best experience as you begin this trial. If possible- please let us know how you are managing with the process.
I am glad you're doing well and in cycle 12. Where are you located and where is your treatment site? I had a very bad reaction to the nivolumab in cycle 2 (i.e. the first time it was administered). They took me off all trial drugs and gave me high doses of prednisone. My side effects have diminished, and I'm feeling good at the moment (still off CT drugs and on prednisone), but next Tuesday will have blood test and see doc to decided next steps vis-a-vis clinical trial. Apparently, options are: off trial, continue trial, continue only rucaparib, continue with lower doses of one or both. I'm so glad the trial is working well for you, and I'd love to stay in touch as things develop.
Wishing you the best outcome possible. Hope you are both feeling well and managing today.
That is the one comfort of the trial participation, the monitoring!
I have to admit I was also in shell shock from all this and it was almost too much to think of 29 more months of a trial. I am finally feeling like I can move forward. We, my husband and I, go hiking as often as possible and I'm starting to feel my strength returning. It is not easy to find much on ovarian cancer so I also appreciate hearing from you. There is one other person in Kelowna on the trial. Sounds like you are not on placebos which is good... they are most concerned with the immunotherapy... sounds like you are in good hands.
Lets keep in touch...
Since we both know exactly what each other is going through.
And as Sunshine Girl said.. may we all have the best possible outcome.
I imagine that this whole coronavirus thing is going to affect lots of clinical trials. I was due to do the questionnaires on Tuesday, and of course, some of the questions no longer made sense - things like are you able to do all the things that you normally do, etc. I'm going out for a walk everyday, and following an on-line exercise program, but still spending more time sitting around the house than I would ordinarily do. My fatigue in the past would manifest itself when I was out and about running around, and then I'd get home and find myself tired to the point of nausea. Naturally, I can't tell if that would still be the case.
Joanne - I'm so glad we've found each other, and I'd like to hear how you're doing, and how the current coronavirus is affecting you and your situation.
Jobo
I am also very grateful we have found each other. Take this time as a gift and believe everything is in it's right place at the right time.. after all just the fact that we were diagnosed is a miracle...
Stay healthy and let's stay in touch.
Joanne
Since I started back on the rucaparib on Tuesday, the only thing I notice is a slight worsening of the neuropathy, and changes in my taste buds. All of these things are on the Mayo Clinic list of rucaparib side effects, but I'm not sure how the prednisone interacts with that. Last night I had a bit of nausea, but I thought it might have been because I ate too much chocolate!
Stay well, my friend.
Jody
Looking forward to hearing from you. XOXO
Thank you for sharing your experience to help others.
As it turns out, I'm now thinking she made the correct call. Right after she made the decision, my vision started to go. It turns out I have developed autoimmune bilateral uveitis, which both the site lead and the Eye Institute doc feel is probably related to the nivolumab. Interestingly, I only had 1 infusion of nivo, and that was at the end of February. It seems that it can have nasty delayed effects. I am typing this without being able to see either my keyboard or my screen. When I'm done, I'll put my nose right up to the screen to proofread. It's been about 2 weeks so far, although thankfully, there are signs of improvement! My optometrist told me this week it can be a month or two until my vision returns to normal.
I'm glad the trial is working out well for you. I hope the results of your CT scan and bloodwork this week are good. It can be very nerve-wracking waiting for results. I have an upcoming CT scan on Friday and bloodwork on Monday too. I wish us both good news!!
Jody
My vision is still improving, but they say it will be about another month before it's back to normal. All other side effects have resolved. Next CT scan and bloodwork will be in about 3 months. I am feeling really happy that they are continuing to monitor me so closely.
I know you had a CT scan and bloodwork last week too. Is everything all right? Please keep me posted. XOXO