[00:00:00] Speaker A: Foreign.
[00:00:08] Speaker B: My name is Nancy Farrow, also known as Mama Lu and I'm the founder of Epic Experience.
Epic Experience mission is to empower adult cancer survivors and thrivers to live beyond cancer.
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This is beyond cancer.
[00:01:14] Speaker A: Hello everyone. This is Gail, aka Sunshine.
Welcome to episode two of our special two episode series where we're discussing clinical trials with two medical professionals. So I want to welcome back Dr. Liu and Dr. Wilke. I appreciate you both joining us again.
[00:01:33] Speaker C: Thanks for having us.
[00:01:34] Speaker A: And today I am going to ask, instead of asking for your background, since we got that, I'm going to ask for one fun fact.
Anything, anything at all. Dr. Wilkie, I am going to ask you to go first.
[00:01:47] Speaker C: I actually majored in music in college as an undergraduate and played piano and did all that before I wound up going to med school.
[00:01:57] Speaker A: Awesome. That.
I love it.
Dr. Liu, how about you?
[00:02:01] Speaker D: We're gonna have to have Dr. Wilkie play the piano.
[00:02:04] Speaker A: Exactly.
[00:02:05] Speaker D: So my second kid, when she was born, we actually got discharged from the hospital. My wife was in labor and actually delivered her on the highway.
[00:02:15] Speaker C: Oh no.
[00:02:18] Speaker D: That girl is now 11 years old, which is crazy. But that was, that happened at midnight. That was super fun.
[00:02:24] Speaker A: Wow. Yeah.
Both of those are firsts, so thank you very much for sharing those.
So today we're going to drive dive a little deeper into specifics about clinical trials. Our first episode, in case you missed it, was a more general, high level overview. And this time we're going to get a little more specific. So the first question I want to ask is when should someone consider a clinical trial? In other words, when on their individual cancer journey, is this something that they might want to start considering? Dr. Wilkie, I'll let you go first.
[00:03:02] Speaker C: My short answer is at every step in the patient journey, frankly I am biased, but I am very, very passionate about clinical trials. And I really think that all patients should be explained about what a clinical trial is and what those options are, starting from diagnos.
It's true that early on where patients may have like localized disease and that can be addressed with standard chemotherapy, radiation, surgery, something like that. Like, yeah, it may, there may not make a lot of sense to sort of deviate from standard treatment when you're on a curative paradigm. But certainly for patients who have been told you have stage four cancer and Right now, we don't have a treatment that can cure you. That should cue discussions about not only standard of care options, but also any potential clinical trials that are available at that point.
And the different types of clinical trials may change depending on where exactly you are in the journey. But always the right answer is, are there clinical trials that I might be a candidate for, in my opinion.
[00:04:09] Speaker D: I couldn't agree more. I think that it's a question that you can ask your doctor anytime. And just like Dr. Wilke said, sometimes we do something like it's an early stage cancer and this cancer gets cut out and then you're just done. And you might be meeting with a doctor just to make sure the cancer stays away. But even in that situation, it's okay to ask about, are there clinical trials that are out there for prevention? Because we know that there are clinical trials that investigate obviously new therapies in the metastatic setting, but there are also clinical trials to try and keep cancers from coming back. And so just like Dr. Wilke said, just ask your doctor at any part of the journey, of your cancer journey. Are clinical trials right for me, what's available out there? And is that something that you would recommend? You ask those three questions every single visit.
I promise will not be annoyed by that. And you're just really advocating for your own care to get the best that's out there right now.
[00:05:06] Speaker A: Yeah.
One thing I'm wondering, because I've never personally been part of a trial, is what is it like? Like, what is the day to day journey of a clinical trial and how is it different from the standard chemo radiation course of action that someone might take?
[00:05:26] Speaker D: So when you think about entering into a clinical trial, you'll have this discussion, much like we're talking about on this podcast. But what, you know, what would entail getting into a clinical trial? If you do agree or think that you want to be involved with a clinical trial, the first thing that will happen is actually signing the consent form and what we call a screening visit. And when you sign the consent form, this is usually a fairly large document that goes in, why are we doing the trial? What are the risks? What are the benefits? What are the calendar of events? So how many times will I have to be at the hospital to do certain tests or procedures or even to receive treatment? And so you'll sign that consent form and then you'll undergo what we call screening procedures. And all this is is essentially trying to meet what we call the eligibility of a clinical trial. What are the parameters that I have to have in order for me to participate in the clinical trial. And so you'll get some labs drawn.
This may include an EKG as well, including potentially an ultrasound of your heart.
We sometimes require biopsies on clinical trials and so you may get a CT scan, may get a biopsy. Every clinical trial is different. And so sometimes these screening procedures can be a lot, sometimes they can just be as simple as just grabbing some labs and then you're done. But after that, and this process usually takes about one to two weeks, one and one and a half weeks and then after that you get started on treatment. And one of the nice things about being on a lot of therapy clinical trials is that you get something called the clinical research coordinator and the clinical research coordinators kind of like concierge medicine. It's kind of like your Sherpa, right?
Where to go and what to do and what's really nice. And it's, it's just improves the communication.
Clinical trial research coordinators can be another member, a valued member of your team.
And I think that this is one of the reasons why patients do better on clinical trials even when they're just investigating standard of care chemotherapy because you have somebody who's guiding you through the process, navigating you through the process. And I think that communication can sometimes honestly improve patients health and the care that they receive. But that's essentially how you get started on a clinical trial. So we just wanted to give people that type of information.
[00:07:41] Speaker A: Today's episode is brought to you by Lilly. Cancer changes lives. Clinical trials can change cancer. To learn more visit cancer clinicaltrials.lilly.com that's cancerclinicaltrials.lilly l I l l y.com.
[00:08:00] Speaker C: Yeah, I think that patients love being on a clinical trial because they get not just their doctor or they get the extra PAs or the nurse practitioners who might be seeing the patients as part of the, and they get their coordinators but then they might meet extra pharmacists because every, there's like this whole other level of oversight and just you know, making sure and double checking that every single detail is being followed according to this protocol which is essentially a set of instructions as to how the treatment should be given, what is the monitoring that's required, what are the criteria to be treated or not to be treated, all of those things. But it's, it's much more stipulated than, than there might be with other types of treatment. And so what that means is then on follow up visits you're going to see your doctor more Frequently you're going to get asked about every single side effect and every single thing that happened to you since the last time you were here. Whether that was, oh, you know, I got in a tussle with my dog and I scraped my arm up. You know, we, we actually capture that we care about that because these are our patients who are on a potentially a brand new drug that's, that might not have ever really been studied in people before. Right.
Learning as we go about everything.
And that may mean longer days than you might have if you were on a standard treatment. That might mean a few more extra EKGs as we monitor and check your heart and make sure that the drug is not having any weird effects on the heart. So there it is. Every trial is a little bit different, but at the end of the day you are contributing to research is something that has not been known before. And we make the most, we try to learn as much as we can from every single patient.
[00:09:42] Speaker A: Yeah. And you may have just answered this question, but how long do trials usually like this, this day to day Sherpa ing along the trial and all the, the extra EKGs and the blood work and all those things.
Is there a typical length for a trial or does it really vary from cancer to cancer person to person?
[00:10:01] Speaker D: It really will vary from person to person. I will say to Dr. Wilkie's point, a lot of these procedures that we have to do, they're really front loaded. And so, you know, after the first month or so, the time requirements to be on a clinical trial really start to decrease.
We tell patients is oftentimes the clinical trial will go for as long as either two things happen. The patient wants to continue, it's going to keep going. And then number two, the cancer is not getting any worse. If the cancer gets worse, then we certainly want to get somebody off clinical trial, try something different. But also again, to bring home the point that the patient is always in control. So the clinical trial can stop at any time that the patient wants.
But if the, if the drug is working, if the cancer is getting better, that trial is going to go.
[00:10:42] Speaker A: Yeah.
[00:10:43] Speaker C: Okay.
[00:10:44] Speaker A: Okay. And then I want to shift a little bit to go into a specific kind of trial called investigator initiated trials. And first I'd like to know what those are and how they differ from the pharmaceutical sponsored trials. And Dr. Wilke, I'll start with you on this one. Sure.
[00:11:03] Speaker C: So I am again also very, very passionate about, about investigator initiated clinical trials. And I'll tell you just a little bit about how they're different so, so when clinical trials are designed and funded, what a lot of us think of are pharmaceutical companies that are trying to get a drug to market, for example. So let's say they've done a lot of research or they may be some smaller studies. The drug looks promising and we're trying to get that as an approved option where your doctor can write for that for a particular type of cancer.
Those studies are led by largely the pharmaceutical companies who meet with the Food and Drug Administration or the fda. And there's a lot of strategy that kind of goes into that about, you know, which particular patients will the drug be designed for and how many patients do you need to go on the trial. But those are sort of, you know, bigger picture trials that are led a lot of the time by the market or where the priorities are for the development of that particular country or company, not country.
An investigator initiated study could be a doctor who's just seeing patients in clinic here and makes an interesting observation, or a scientist who's in the lab who's been studying X type of cancer for decades and finds that, hey, you know what, I used this drug that was formerly used, I don't know, to treat a bacterial infection. And when I treat the cancer cells in the lab with this drug, wow, I'm seeing a lot more cancer cell kill than I would have expected.
And so an investigator initiated study can be designed to follow and to test a unique idea that comes out of either a clinical doctor's observations or from the laboratory and then can go into be tested in patients. And there's a lot of different variations of this, but the idea with these is these are the ideas, these are the light bulbs that go off in the day to day of our jobs and they can actually really have dramatic impact on patients. They're typically small studies where maybe just a few patients are being tested. These are never going to be, you know, designed to go to approval at the first stages. Right. Like, you know, I'm, I'm not going to develop the cure for pancreas cancer while I'm sitting here in clinic, you know what I mean?
[00:13:22] Speaker A: Right.
[00:13:22] Speaker C: But they are the first ideas and they're the pilot ideas, the high risk, high reward ideas. So these can be incredibly exciting. And as part of my job, we have a group here at the cancer center that's designed to help foster and nurture those new ideas that are coming out of the lab or coming out of investigators in clinic to make those reality so that patients can participate in those studies.
So I think it's A really cool idea and a different way to do research. That's really important.
Chris, I don't know. You were the IIT guru long before I was.
[00:13:55] Speaker D: I think that's put perfectly.
A lot of times investigator initiated trials are really based off of data that's produced locally to where you live. And what's really neat about that is that these are some of the best ideas that researchers have in your area that have led to then a clinical trial that's a lot of times only being done in your area. So it's a very, very neat type of trial. And if you ever hear investigator initiated trial, that should provide some excitement for you.
[00:14:24] Speaker A: And yeah, ask again. As we've been saying, ask, ask about it.
So why are initiator. I'm sorry, Investigator initiated trials important for innovation in cancer treatment and how do they impact patient care?
I think there are. It seems like there's a particular niche there because they are local, right?
[00:14:46] Speaker D: Like, absolutely. I think that sometimes investigator initiated trials really address some of the issues that people are having locally. Right. Because we know cancer can be even different across regions or some of the things that people struggle with or have challenges with may be specific to a region. Investigator initiated trials can really address some of those more regional or local issues. The second part of this is that a lot of times this is really data that's coming out of laboratory studies that really aren't being funded by pharmaceutical companies, which means that they're really just following the science, which is really, really neat because sometimes these ideas really come out of just learning more about the human body. And then you learn something and you say, okay, well we might be able to use this to treat or prevent cancer. That is super exciting. And so when you see these IITs or investigator initiated trials come through, they're really being driven a lot of times out of the science and the observations that are being made in the local laboratories.
[00:15:46] Speaker C: Yeah, especially for rare tumors sometimes. Again, I'm a sarcoma doctor, so rare cancers are my thing, but we don't always make the top priorities. Right. So sometimes. And sarcomas are over a hundred different diseases, each of which are unique. So that's very, very hard for a pharma company to kind of run a big sarcoma clinical trial sometimes. But we can if I have an idea and you know, we have a study that we think might be effective for X type of sarcoma. You know, it may. I've had patients travel from all over the country for a study that's only available here in Colorado, because for whatever reason, I got this wild hair brained idea and we're doing a clinical trial to test that. Right. And so it's, it's, it's again, sort of an opportunity for patients who might not have options in bigger, more standardized studies to still be a part of clinical trials.
[00:16:37] Speaker A: Yeah. That is fascinating. Well, thank you both so much. Is there anything I haven't asked you about clinical trials? And specifically the specifics, the details that someone might be wondering?
[00:16:53] Speaker D: I think the biggest thing that we want people to take home are really maybe two things. Number one, we want people to hear the excitement about this. I think, again, the most exciting time ever in cancer medicine. And that's really being driven by clinical trials. But then number two, the biggest thing to remember is just ask. It's okay to ask. You'll never be annoying anybody. And it just is going to lead to a much better conversation, even if that doesn't lead to a clinical trial.
[00:17:17] Speaker C: Yeah, yeah. The other thing I would just say is sometimes it's really hard to find information about clinical trials online. So if you are a patient and you're trying to comb through something called ClinicalTrials.gov, which is this massive database of every clinical trial that's out there, you can drive yourself a little bit crazy because it's just the system is confused, confusing, and sometimes not all the information's there to know if you're a candidate or not. So absolutely. Ask your doctors. Like, we spend our days thinking about clinical trials, going to meetings and networking with other docs in our field about what studies are out there or might be coming down the pipeline. So just, just ask us and, and again, we will, we will always support, you know, you've. Knowing all of your options and, and helping you guys make the best possible decision.
[00:18:01] Speaker A: Thank you.
Well, the most important question. Well, maybe not the most, but one I'd love to close with marshmallows over a campfire. Slow and steady or flame and crispy?
Dr. Wilkie, I'm gonna start with you.
[00:18:15] Speaker C: Okay, so this is really. So what I like to do is melt mine indirectly first, and then at the very end when it's huge and exploding and gooey, then you scorch it. You gotta have like that crisp, that fire smoked thing on the outside at the end.
[00:18:29] Speaker A: Love it. Love it. Dr. Liu.
[00:18:32] Speaker D: So this is probably why I'm not a surgeon, because I strongly prefer slow and steady. That is the right way to do it. It's extraordinarily important. But to that point, mine usually catch on fire.
[00:18:43] Speaker A: Yes, in the effort of slow and steady, flaming often happens. This is. Yes.
Well, thank you both Dr. Wilkie and Dr. Liu for joining us. Thank you for sharing your insight and your enthusiasm. It is. It's clear that you both are very passionate about this, which is really neat.
And those of you listening, until the next time we gather around the campfire, keep Living Beyond Cancer.
Thank you for listening to this episode of Campfires of Hope, Living Beyond Cancer. For more information about Epic Experience and our programs, or to donate, please visit our
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[00:19:48] Speaker C: Time.
