Anyone participating in the ATHENA clinical trial?

jobo

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. 

Flowergirl

Hello @jobo... welcome to the chat site and thank you for sharing your story. How are you feeling now that you have finished your treatment? Do you have access to support at your cancer centre to assist you with your decision making (like a NP/nurse educator or psychosocial support)?

Flowergirl

@Marilyn - can you offer any info on the Athena Trial?

jobo

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.

Flowergirl

Hello again @jobo - thank you for sharing the update. That seems like good news that the Ottawa hospital trial site is now open... we are in such hopeful times now as there seems to be many changes on the horizon for treatment and trial options. 
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. 

Joanne

I am in the Athena trial. Im in cycle 12. I would love to talk to you about your experiences. It has definitely been worth while.  I travel to the centre every 28 days. Monitoring is amazing. Let me know if you have any questions. I believe there is one other person in the trial here... not sure how many there are of us. Thanks for reaching out. XOXO 

jobo

Hello @Joanne.  Thanks for getting in touch with me.  I had joined several forums looking for people on the ATHENA trial - CancerChat.ca (nothing) Ovidialogue (nothing until you!), and Smart Patients.  On Smart Patients, I found 1 person who was on the trial (started last July), 1 person who had been on the trial but left if when she got a recurrence after 6 months, and 1 person who is just nearing the end of her chemo and probably joining the trial.  

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.  

Flowergirl

Hello @jobo and @Joanne - great you have both been able to connect here!
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!

Joanne

 Hi Jobo great to be in touch!!  I'm living an hour and a half from Kelowna the trial site. I had nausea from rucaparib which lasted for months however my body has adjusted to it and no side effects now.  The nivo gave me a bit of a rash in the beginning . Now I feel very tired the first week after the IV then better. I've always had migraines and I'm finding headaches are worse that first week. However everything has been possible to manage.  It was a very difficult decision to join because like you I was concerned about the side effects.  And really didn't want to continue with chemo once I had finished my 6 rounds. I'm grateful now to be in this as not everyone is a candidate.  I found the videos of the women on this sight extremely helpful and uplifting. Ovarian cancer can be pretty grim.  
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. 

jobo

Hi @Joanne.  I was glad to hear from you.  Well, I saw the gyne-onc on Tuesday, and we made some decisions - I hope they were the right ones!

I'm off the nivolumab for good.  She thought that my body reacted to it too strongly and felt there was no point in further challenging it.  I'm back on the rucaparib or placebo,  though at a reduced dosage.  I hear about so many people who tough out their parp inhibitors at the full dose, and I'm wondering if reducing dose right away is really the best way to go.  Plus, I was never as sure as they were that it was the rucaparib that was causing the nausea rather than the nivolumab, since it didn't really start until after my first infusion of the nivo. Anyway, it was a whirlwind visit to a hospital on lockdown and doctors and staff feeling stressed and wanting to make decisions and move on, so I perhaps didn't question things as much as I should have. 

It also turns out that they are not going to accept any more new patients into the trial at this site.  They feel that as it's a maintenance trial and hospitals are dangerous places now, it's not worth putting people through the risk of all the hospital visits and screenings they would have to do at this time.  So I'm the one and only here!  And since I'm now in cycle 3, and no longer on nivolumab, I will only have to visit the hospital once a month from now on, except for scans and things like that.  

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

Joanne

I think they made the right decision regarding your medication. At this point there is no one best way.. and quality of life is also very important.  People had to keep reminding me.. especially my husband I was still recovering from the whole experience starting from diagnosis to operation to chemo then right into the trial. Of course you are tired and that's perfectly normal. I am just starting to feel stronger after a year on the trial. Our bodies need time to heal. We have to accept that. Take naps. And walk. And be good to yourself. The Kelowna center is still open I go in twice a month. Once for blood tests and to see the CT nurse and oncologist then next day the Nivolumab. Honestly I was considering quitting many times.. the pills were making me feel so sick.. however it was always manageable.  They dont fool around with immunotherapy.  I am able to go for a hike now and can feel.myself getting stronger. You're right this is now very complex as to why we are feeling tired or sick.. I find social situations tire me out and I was learning to pace myself. One day busy one day resting. 
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

jobo

Hi Joanne.  Thanks for your message.  Actually, I'm feeling quite well now.   I think it's partially the prednisone they gave me for the nivo side effects which I am still on (once you start, you have to do a six-week taper).  It gives you super powers.  In the last 2 days, I have rearranged my garage, swept it out of all the accumulated debris and mud of winter, reorganized my kitchen trash to separate compostibles from garbage (and actually put on rubber gloves and went through my existing disgusting trash making the distinction), baked cookies, fixed a really annoying technical problem I was having with the streamer for my hearing aids, found a bottle of 70% isopropyl alcohol in among my gardening stuff, fitted it with a spray nozzle and cleaned all touching surfaces in my car and my house, gone for 2 lovely walks and worked out to my beginners exercise video, did a video chat with my cancer support group, and on and on.  The only problem, the prednisone makes me ravenously hungry at all times, and keeps me awake at night.  

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

Joanne

Hi Jody.. so sorry.. I just saw this.. however it was wonderful to hear your progress and level of energy. Way to go! There are 3 of us now in the trial conversation. I hope you are continuing to feel well. I go this week for the ct scan blood work doctor visit and treatment.  Im now in cycle 14.. which seems amazing. Time flies when having fun. 😘. So far I'm doing well. All manageable ... 
Looking forward to hearing from you. XOXO  

Flowergirl

Hello again @Joanne and @jobo - glad you were able to connect and it is nice to hear you are managing ok @Joanne
Thank you for sharing your experience to help others.

jobo

Hi @Joanne.  Well, my news has changed.  I've been taken off the trial.  Have been having lots of side effects, even after I was off nivo and on rucaparib only at the intermediate dose.  My site doctor felt that in her clinical opinion, the potential benefits did not outweigh the risks.  I tried to convince her to let me go back on rucaparib at the lowest dose, but she felt my body had already been through too much.  

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

Joanne

OMG... that is unbelievable.  Yes definitely stay off the trial. I have a feeling you will be carefully monitored and who's to say what works best... we are all so different. Hope all your tests are looking good. Yes a very stressful time. Talk again soon. XOXO 

Flowergirl

Thank you for sharing your situations @jobo and @Joanne ... - sorry you are having those difficulties and hope they can get resolved for you.

jobo

Hi @Joanne.  Good news.  Got the oral results yesterday from my CT scan and blood work last week - no evidence of resurgence of cancer!!  My CA125 is still creeping upwards, but the doc said it's the CT scan that counts.   I was so relieved and elated that I slept for 2 hours.  Then ordered dinner in to celebrate

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 

Joanne

Great news. Im so thrilled. Yes I also got a clear scan too. Great news for us both. 

jobo

Yay!!

sdwway

I am soon to finish chemo and was just advised by the London Cancer Clinic that the Athena study is closed to new accruals. Has anyone heard why, and if it's temporary?

jobo

I can't answer for the study overall, or for the London Cancer Clinic.  I was told that in Ottawa they decided not to accept any more subjects (I was the first and only one) due to the pandemic.  They felt that the risk to patients of all the hospital visits they would have to make was too great for what they called "only" maintenance.  

sdwway

Thanks, maybe they'll open it up again if the situation improves.