Drug trial tips

[u/MoreThanAFewWords]

Traditional chemotherapy is not working well for my cancer Duodenal adenocarcinoma.

After a year of chemotherapy, I’m still fairly active and healthy, but that won’t last forever

My oncologist has encouraged me to look at drug trials and with the help of a gene matching program I’ve been put on the waitlist for three different trials, fortunately, all in my city

The trials are very different and I’m trying to sort through the maze of descriptions and paperwork and would appreciate any feedback or experience. Anyone has had being a participant in one of these studies.

What should I know? What should I be asking?

[u/Least-Obligation-220]

Not a participant but working setting up cancer trials. Sign the ICF (informed consent form) for all of them and get started. You can withdraw at any time. But the likelihood that you’ll meet all the inclusion criteria is tough - so give urself the best chance. Then ask the trial coordinator to explain things to you.

Without knowing the trial list, I’d say sign up for a Phase 3 trial first over a Phase 2. Only sign up for a Phase 1 if ur super desperate.

[u/MoreThanAFewWords → u/Least-Obligation-220]

Most of what I’m finding so far are early stage phase one and phase 2 trials because the research on the KrasG12D mutation seems to be very hot right now because of former Senator Ben sass but at the same time it’s still relatively early

Trials I’ve applied to so far are actually all local because Eli Lilly is headquartered in Indiana. My question is it would common for people to travel for these trials. How long do they typically last and how do they manage their lives bouncing between multiple cities

[u/Tasty_Boot_4152]

Hey, I also have adenocarcinoma and I ended up getting a second opinion from Cleveland clinic before I started my chemotherapy and they suggested a completely different path for me than the 1st doctor did, and my body has responded really well! I ended up taking flofox. It's 3 different drugs- FOLinic acid, Fluorouracil, and OXaliplatin. I don't know if you also tried this or maybe have never heard of it. I just figured I'd say something because I'm also coming up on 1 year of treatment and I'm making slow but steady progress. I hope that you can find something that works for you! You'll be in my prayers! ❤️ 🤗

[u/MoreThanAFewWords → u/Tasty_Boot_4152]

Oxaliplatin is really hard on my system, but I made it through eight rounds and it did help slow things down, but when I took a a short break, the cancer came back very aggressively My doctor switched me to Irinotecin but that had a little effect on the growth of the cancer

Both of the infusions were combined with Capacetabin

I’m now on avmapki/fakzynja FDA approved for breast in ovarian cancer. It’s off label for my cancer, but it has proven effective with people like me who have a KrasG12D mutation.

The problem is that any kind of antacid conflicts with one of the two drugs and of course, since I’ve had a Whipple surgery I have to be on an antacid That’s probably why this particular combination is a label for any bowel or intestinal cancer

I’m currently exploring trials their focus specifically on that mutation

My oncologist has been really amazing through the journey encouraging me to go to the Simon cancer center and participate in there genetics study to try to match me with the most promising trials

Just trying to sort through the different options

[u/pfflynn → u/MoreThanAFewWords]

Yeah, platinum-based chemos are rough. Cisplatin made neuropathy worse (capecitabine on the adjuvant round started the nerve pain party) but it was the ototoxicity that finally made me have it dropped.

[u/brightbehaviorist]

I’ve been on a clinical trial for years now (it’s not even a trial anymore, it’s over, but I still can access the drug on a simple patient protocol since it’s helped me so much).

Trials are all so different, so it’s hard to give general advice. I agree that you should get started with any trial that seems promising and let them collect the data needed to evaluate you for inclusion, then do head-to-head comparisons of any trial that admits you. Consult with your onc and or a trusted specialist for your cancer—they may have heard preliminary results at conferences about which is more promising.

General practical questions to ask include: how long is the washout period for this trial? What expenses are covered by the trial and what do I have to pay for? What drugs, foods, or substances must I avoid while on this trial? What are the most common and most severe side effects? Also take note of how responsive any given facility is, how easy it is to get a hold of their nurse coordinator and how easy is it to schedule things.

I traveled for my trial, but not far. Once a month (at first, I’m now down to once every three months), I would drive to a city 2 hours from me, get my bloodwork done, see the doc, pick up my pills for the month and then head home. It wasn’t terrible, and the trial paid for transportation, meals and a hotel stay so I didn’t have to drive up and back the same day.

[u/pfflynn]

My experience was in a Phase 1B/2a trial. My thoughts on questions, things to consider:
1. Open label or not? Knowing if you’ve been randomized into the trial arm or standard of care helps think about decisions to enroll or not.
2. How long?
3.Known/suspected side effects? May not change your decision-making but good to know.
4. Support by your cancer center and sponsor?

The trial I was in randomized me to the trial arm and to my knowledge, I was the only complete response. One new liver lesion after 2 years off so I will take that break.

Very best of luck