OVdialogue – consider joining our team in the role of Community Champion. Over a few hours each week, you would be part of a team that helps connect people, support conversations and are thought leaders for OVdialogue. This is your opportunity to give back to those who have/continue to support you through the tough times, share your unique experiences, and help celebrate successes. For more details of what this entails, please reach out to @Mfallis (mfallis@ovariancanada.org).
Stay tuned for more details, and feel free to share your thoughts below. Let’s make this community even stronger!
Best Of
Re: clinical trials
Artistry-7 Trial update!
Trial Arm 1: Nemvaleuken Alfa +
Pembrolizumab
Cancer: High-Grade Serous
Ovarian Cancer
Selection Process
Going back in time…there are many things to consider when you are exploring clinical trials. I want to provide some details regarding the selection process specific to Artistry-7.
TIP: Start a list...write down everything that crosses
your mind when you first consider applying for a trial – the list will be very
useful to begin your conversation with the oncologist.
Clinical Trial Team
When I decided it was time to begin a trial, I was switched from my surgical oncologist to a medical oncologist. At my first appointment, I was introduced to my clinical trial team: Oncologist, Nurse Practitioner, Nurse, and Trial Coordinator.
Medical Team
If you are experiencing something worrisome and depending on the severity, either go to the hospital immediately or contact someone on your medical team.
Trial coordinator
The trial co-ordinator will work directly with you to help you navigate the world of trials and to keep the trial process moving and on track. The trial coordinator is a very valuable resource during the entire process. They are your first-line contact for anything trial-related. They ensure that the trial process is followed and they work with both your oncologist and the lead trial investigator to explore and/or resolve any issues that arise. You can contact them directly with any questions related to the trial. They cannot answer/resolve medical questions. You will see your trial coordinator regularly throughout each cycle. Blood work taken for trial purposes only is not available on your health portal. However, you may ask the trial coordinator to share results with you.
Trial Inclusion/Exclusion Criteria
Discuss the trial inclusion/exclusion criteria with your oncologist to determine if there are any red flags that may preclude you from participating. If you are experiencing any issues that you think may affect your participation in the trial, you, your oncologist or the trial coordinator will contact the lead investigator for the trial directly to get answers and determine your eligibility. The trial uses the grading system for adverse toxicities to determine eligibility (continuation), so do not assume that you will be excluded until you have investigated the issue.
If you are currently on medication, discuss with your oncologist and trial coordinator to ensure that it will not interact with any of the trial drugs.
Pre-trial paperwork
a) Pre-Screening Informed Consent Form (6 pages) – essentially, permission to obtain your tissue sample. The form also contains pre-trial information regarding your choice to participate; what you are being asked to do, why the study is being done; risks and benefits of providing a tissue sample; privacy and confidentiality of your personal information and test results; and conflict of interest. Read the release you are signing and be sure that you understand everything it contains. Contact the trial coordinator if you have any question.
b)
Study
Information and Informed Consent Form (24 pages) – your agreement to
participate in the trial. This form outlines, in detail, everything about the
trial. Read the release you are signing and be sure that you understand
everything it contains. Contact the trial coordinator if you have any
questions.
Pre-Trial Tests
You will undergo several tests to obtain a baseline prior to beginning the trial.
a) Blood work – to obtain pre-trial baseline. The first blood draw is massive – there were at least 15 vials. I have a “Power Port” (port-a-cath) which made the blood draw a lot easier for me. If you are having a vein draw and think you may have issues with the draw, ask the trial coordinator if you are able to split it up over a couple of days. The trial coordinator was present at the draw and was handed the vials directly for trial purposes.
b) Tissue sample – either from archival tissue or a fresh biopsy. I opted for a fresh biopsy. The biopsy was ultrasound-guided and I only experienced a bit of discomfort following the procedure. I opted for a fresh biopsy because I wanted to be certain that they had enough viable tissue samples for not only the trial, but a couple of biomarker studies I had also signed up for. The trial coordinator was present during the procedure and was handed a tissue sample directly for trial purposes. Your PD-L1 biomarker will be tested from this tissue sample. Your results will not preclude you from participating – this information will be entered into the trial database for research purposes. FYI: My PD-L1 count was very low.
c) CT scan – to obtain pre-trial baseline.
d) ECG – to obtain pre-trial baseline and to ascertain that you meet trial parameters for participation.
Of course, your overall health
is the priority throughout the trial. If you require any tests outside of the
trial schedule, they will be done.
Randomization
The trial protocol states "Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine." This means that your oncologist can select any of the four standard of care drugs for the randomization process. Discuss the options with your oncologist so that an informed decision regarding this option can be made.
For me, Caelyx (PLD) was off the table. In discussions with my oncologist, I knew that her choice for the standard-of-care option in the randomization process was going to be Gemcitabine.
Protocol Flexibility
I have provided details in previous posts but, with 20/20 hindsight, I realize that some of these things can be dealt with before the trial begins
a) Trial drug(s) – there is some wiggle room in trial drug dosing. Nemvaleukin Alfa can be reduced to no more than 50%. I do not know about Pembrolizumab, I am still receiving maximum dose.
b) OTCs – each drug has its own cocktail of pre-treatment meds. Pre-treatment medications fall outside of trial protocol and are the responsibility of the oncologist. So, if you are aware of your sensitivity to any of the pre-treatment OTCs, it would be wise to negotiate changes with your oncologist prior to beginning the trial.
c) Treatment scheduling – may be adjusted to accommodate for statutory holidays that fall in your treatment week. You will receive treatment the following week.
- There is a 72-hour timeframe from oncologist exam and blood work to Day 1 treatment. I have not explored alternatives yet, so am not sure what the trial protocol will tolerate. There may be a workaround in order to keep treatment on schedule.
- The trial coordinator does not work on statutory holidays (there is always an oncologist available and chemo is open). The trial coordinator is required on Day 1 due to the blood work requirement. I have not explored alternatives yet, so am not sure what the trial protocol will tolerate. There may be a workaround in order to keep treatment on schedule.
- When you are made aware of your potential start date, sit down with a calendar and mark off the three-week cycles to see if you run into any delays due to Statutory Holidays (Mondays and Fridays) and address them before the trial begins. You can adjust your start date to try to avoid some delays, receive treatment at week 4 when a delay is encountered or try to negotiate a workaround with the oncologist and trial coordinator to keep treatment on schedule.
This brings me to a couple of other things I would
like to point out…
Blood work outside of treatment weeks – blood draws for trial purposes only are required on
Day 15 (and Day 22 if treatment was delayed). The dates and times are scheduled
directly with the trial coordinator (no oncologist appointment required). I
believe this is flexible and can be adjusted (or even missed if necessary).
CT every six weeks – with the state of the health care system, it is
very difficult to get appointments for imaging.
- Ask your oncologist to submit a request for your next CT on Day 1 of the cycle immediately following your last CT.
- If you have special requirements, i.e., port, ensure the oncologist marks this clearly on the requisition so that a nurse can be available to access/de-access the port for the IV contrast. I also have to add a note that my appointment needs to be within chemo hours so that they do not book me when a chemo nurse is not available. (My local hospital is a chemo satellite site and the hours are limited.) I have also had an emergency nurse come down to either access my port or find a vein for the IV contrast.
- I also have oral contrast for my CT scans and always ask my oncologist to add this note to my requisition. The rules seem to differ across hospitals, and I have been caught with it not being noted on my requisition, then being told that I do need oral contrast for the imaging they are doing and then having to sit in the CT waiting room to drink the oral contrast and then wait two hours before the CT can be done.
I
tried to keep this as concise as possible (really, I did!) and on-topic. I apologize
if I wandered, am off-topic or missed anything. I will keep my journalling
going, so there may be new tidbits as I move through this trial process. If you
have any questions, let me know.
GloHo
Re: Let's get started! Come and introduce yourself
To all the ladies
On this topic it can be so diverse in what we feel and where we are with acceptance there of. I, personally, would recommend the book "Hope for the Best, Plan for the Rest" OR go to their podcast series thewaitingroom.com
Here you will find a wealth of info as they delve into what it means to be palliative and the myths around it. It will empower you to see the info they provide is helpful in finding ways to have discussions about the hard conversations with yourself, your health care team and your family. It is something that has been missing in our care journey for a long time. I urge you to check it out in whatever form is best for you. I think you will find it enlightening and may help take away the stigma around "palliative" or for some of us the "recurrence" part and what that can mean for us. It will open up dialogue that should be discussed at some point in time and give you pointers on how to do that in a meaningful way for yourself and your supports. The podcasts have a lot of valuable info to and reflect some of the book as well. If you can I urge you to check it out. It may just give you that peace of mind you are looking for and support to be able to open up this very sensitive subject that has become almost taboo in many households.
It doesn't mean that family won't still have their own reactions etc or denials but it may help you. My hubby has a hard time discussing any of that but when I take steps to ensure that all my T's and I's are dotted should I pass, he doesn't question me and just does as I ask. For truly, I am trying to make it as simple as I can should anything happen to me. All decisions will be made and there will be no hiccups with financials etc because I have planned ahead for them. As always, I am open to discuss any aspect of this with any one of you as I face my own hurdles especially if it will help you in the long run. I face an uncertain prognosis and live with it daily. In the meantime I try my best to live every day for what it is while still planning ahead with all my Legacy work. I get it and I get that some of this is heavy info to intake and process. I am here for you wherever you sit. Just open up and ask.
I wish you all the best and hope you take a look at the info I provided to assist you next on your journey. 💕
Re: TEAL THURSDAYS - Sign in and CLICK HERE TO ENTER LIVE DAYTIME ONLINE CHAT (1pm EST)
I am posting early today as I am not sure where I will be when we begin OV Dialogue today. I am to accompany my girlfriend and her little one today to the local Play with Clay to obtain footprints in clay. Should be an adventure and know the person doing it is experienced and will be quick at it. The wild card is the little one and how she will interact with it all. Mom doesn't leave the house often so she doesn't see a lot of the outside world or other people. Thankfully this is a quick endeavour and I have every faith it will go as smoothly as it can! So, if I am not on right away when we are to begin, please go ahead and start the conversation. I will join when I can! ;)
I thought this quote fitting for this week. For HOPE is what we all have no matter where we are on this journey or what we are experiencing. We have to have the hope to pull us through the multi facets of our journeys and how they affect us emotionally, mentally and of course physically. The challenges we face both as individuals and in our inter personal relationships as we navigate the course of treatment set out in front of us. We face scanxiety as we await our testing and what that may reveal for our next steps for our journeys. Wondering all the while if we will reach NED status and when we do how long that will last. Never prepared for the emotions that go along with that which can include feelings of guilt for feeling good while others are not. Knowing we are able to carry on with our lives and make plans again while we read that others just aren't there and have no idea when they might be able to. To be accepted for trials that are out there and have your health team on board with all that brings including the hope that it works and they have figured out that "magic" formula for you specifically and what your disease is doing to your body. Hope that we find the courage every day to continue on despite any negative news including being informed that there is nothing more they can do for oneself. What does that look like for you and how would you handle it? Well, one doesn't know until you get there and the state of mind you are in at the time. At that stage one can only hope that your team is there for you to mitigate your symptoms as they creep up and make you as comfortable as can be. That one can stay where you want to be for as long as you can pain free and as symptom free from whatever creeps up. Hoping that our bodies cooperate and listen to us as we talk to them and bargain for this or that to get through the day. Hope that the family understands your choices you have made throughout your treatment and thus far and will continue to support whatever decisions you have made for the end. Hope is a four letter word that carries so much weight and meaning in it that we need to make sure we don't take it for granted and cherish the hope we find along the way to help us through our own personal journeys. So take a moment and reflect and don't ever forget what HOPE can mean and do for any single one of us on any given day. As the book says, "Hope for the Best, Plan for the Rest". It is really the only thing within our control.
On a lighter note, what has been going on in anyone's world and how has treatment been? I haven't heard from many of you in awhile and hope that is a good thing. I am curious as to how our @babs272 is doing and if she could give us an update. Any of you that haven't posted in awhile, why not give a shout out and let us know where you stand today, good or bad and let us share in your journey. Just reach out and let us in…..that is all it takes……you would be surprised the support you will receive and possibly what might "pick you up" today. It may be all that you need to help you carry you through your day! 💕
Re: TEAL THURSDAYS - Sign in and CLICK HERE TO ENTER LIVE DAYTIME ONLINE CHAT (1pm EST)
@Hooodith How did the visit with your friends go yesterday? Were you able to go? How was the smoke and your hubby's asthma as a result of the smoke? It is incredible what the fires will and can do and the devastation it wreaks on nature and families alike. Shows us Mother Nature still is the boss lady.
The one time chemo session sounds promising. How do you feel about it as an "in between" as you await until after the wedding to resume any "normal" type of treatment. Sorry and sad to hear you have been unable to really mourn the passing of your friend like you should have been able to do. Joining the grief group sounds like it could be very helpful to yourself and all you mourn for your own illness and also the loss of your friend you were unable to process at the time. You are taking all the right steps to healing and that is amazing in and of itself. Big steps if you ask me because you are not only finding them but following through with them too which is the biggest step of all. Proud of you! Keep up the good work you are doing on yourself!
Good for you for initiating the turkey tail mushroom powder on your own even if your Oncologist is a bit skeptical about it all. All I know is that we don't have much on the table and it is harmless enough why not. Especially if it doesn't interfere with conventional treatments either. One never knows what will happen and what it will or won't provide for us inside and our healing journeys. Something to have faith in when we can sometimes feel there is nothing left.
Today is Sunday and the last day of the weekend in my home. Hubby has offered to take me for a walk and to get an ice cream later. He has surprised me because this is something I usually do with the kids and not him at all. But I will take what he is offering and embrace the memories we will get from it. Us waiting in line in the heat, him sweating, him commenting on how many people are there and then the walk to where the geese are all over the place. LOL Something I am used to but will be nice just the same. I think he has pulled some fish out for dinner which will be nice and hopefully my tummy will agree with it too. So far it is back to behaving itself but who knows how long it will last. I take every day for what it is and pray it accepts what I put in it gracefully and without incident. It feels good to feel good and I just pray it lasts longer and longer each time.
Whatever you get up today, enjoy it and whatever the weather brings along with it! 💕
Re: TEAL THURSDAYS - Sign in and CLICK HERE TO ENTER LIVE DAYTIME ONLINE CHAT (1pm EST)
@Sandi6
So glad you’ve found a trial!
The EPOCH study is actually one I was looking at! Unfortunately, I have had so many treatments now, I’m finding I meet more exclusion criteria than inclusion criteria for most trials now 😵💫.
GloHo
Re: TEAL THURSDAYS - Sign in and CLICK HERE TO ENTER LIVE DAYTIME ONLINE CHAT (1pm EST)
@Strongwoman
Sorry to hear you have the doldrums! That creeps up on me once in a while too.
I just woke from an unusually long nap - guess I must have needed it. I am finding that I am more tired the week before my next treatment. Just made myself an iced coffee…yum!
Not much new with me.
I should be starting to get things together for the cottage at the end of next week, but am having a hard time getting going on that…I haven’t even started my list yet!! 🤣 We are going to a cottage in Quebec and we’re thinking of leaving a day early and stopping about halfway to sleep over. That way, I don’t have to do the 6-hour trek in one day. Have to find a pet-friendly place and some sightseeing detours along the way.
I did my car windows and some interior car dusting last week [lots of construction(dust) out this way], vacuumed the car today (well over due!) and will give it a good wash another day. Can’t do it all at once anymore!
I have, hopefully, treatment next week. Then we head off to the cottage. After that, I have a CT scan. My results have been so whacky that I don’t know what to expect with this one 🤣🤣.
I still have a lot of things I want to do around the house…donate stuff…sell some stuff…most of my paperwork is in order but still a few wishes I have to put on paper.
What’s important is that I still, amazingly, feel okay after 5 years of being diagnosed. So grateful and thankful to the 😇😇😇 watching over me. 🙏
GloHo
Re: TEAL THURSDAYS - Sign in and CLICK HERE TO ENTER LIVE DAYTIME ONLINE CHAT (1pm EST)
I am in A Study of 23ME-00610 in Patients with Solid Malignancies. It is a Phase 1/2 trial.
The other trial you mentioned is Study Looking at Biomarkers in Ovarian Cancer (BIODIVA). Here is a brief summary about the study:
This is a sample study that will collect biological samples (blood, tumor tissue, ascites, and/or other fluids) from gynecological cancer patients for biomarker research. In addition, the results of the testing done on the samples will be given to the participant's treating physician who may use the information to guide treatment decisions.
I believe quite a few of us have participated in this one to determine if we have a mutation or biomarker that would benefit from a drug developed or being developed (trial) that would target the specific mutation/ biomarker.
I, myself, did not have any biomarker or mutation out of the norm so continued on standard of care regime - with a couple of trials along the way 😁.
Let me know if you have any other questions.
GloHo
Re: Last chemo delayed due to low platelet count
I probably should have said that "my Oncologist" allowed this. It may be dependant on the Oncologist - they may have different rules or preferences. Sorry. Hope it works out for you.
GloHo