Responding to Roxanne, and to get conversation going again (it starts up every so often) about clinical trials, I'm going to write some stuff. But I want to start by emphasizing that it's different for everybody.
For starters, where are you at in your 'journey' as we say?
Is your doc offering and/or recommending a clinical trial at your institution? Is it a Phase 3? Is the projected total enrollment high? Like in the hundreds if not more? Typically, that means that there are two (or more) arms (variants), one of which is the current standard of practice, i.e., what you'd get it you didn't sign up for the trial. The other arm includes the experimental drug or technique or schedule. You don't get to choose which you're on. You're assigned at random to one or the other. Sometimes the trial is double-blinded, which means you don't know which arm you're on and neither does your doctor. Other times that isn't possible.
In principle that's the best kind of trial to be on, because it implies that there's lots of evidence supporting the new approach, as well as lots of evidence for its safety. But guess what: about half the time, it turns out not to be any better than the old approach, the standard of practice. Rarely does it turn out to be significantly worse. So whichever arm you get assigned to, you can feel that you're getting good care. And you can take some satisfaction in furthering knowledge that will help other women down the line.
I want to add one thing: I would be inclined to prefer a study that includes some kind of analysis of the cancer tissue, not just determining what type of cancer it is.
Remember, there are exceptions to every general statement I'm making here, and if I went into them all, this would be unreadable.
I haven't been in any Phase 3 studies. Why not: I wasn't offered one in my first-line treatment, nor after my first-line treatment was completed and I was NED (no evidence of disease), nor at my first recurrence, seven months later. Those are the landmarks when you're most likely to be eligible for a Phase 3 study. I knew nothing about clinical trials, and nobody told me anything. I wasn't on this listserv.
Most trials are Phase 1. These are studies designed to assess safety. And by the way, they might also see whether it helps anybody. Eligibility for a Phase 1 is much less restricted than for a Phase 3. Phase 2 studies are done if a drug makes it through Phase 1 with a good safety profile, and looks promising enough to move forward with.
I've been mostly in Phase 1 studies (9 of them, with some additional wrinkles), and one Phase 2. The Phase 2 was ineffective, and that drug never made it to Phase 3. That often happens. More of my Phase 1's were ineffective than effective, or I was dropped early because of what were considered serious enough Adverse Events (AE's). That ends up meaning that I didn't spend much time in trials that weren't working for me, nor in trials that were putting me at risk. I generally spent several months in the trials that did work, staying until my cancer became resistant to the trial regimen.
But that's me. I don't get remissions any more. My cancer finds a way around the treatment within a few to several months and comes roaring back.
And that's why I have 10 clinical trials under my belt, so to speak, and I think that's why I've just made my 8th cancerversary. It makes sense for me to try to lengthen the list of "options". If I buzz through the list of drugs FDA-approved for ovarian cancer: Carbo, Taxol, Doxil, etc, some of them working, some not - I get very quickly to the end of the list, and have gone through it too quickly to go back on the ones that worked, because my cancer's still resistant to them. It's generally thought that the longer it's been since your cancer has seen a particular drug, the better, especially platinum.
And it's more complicated than that, depending on your medical status, your particular genetics, the genetics of your cancer, drug combos, schedules, delivery methods (IV vs. IP .). But the upshot is that the list isn't long, and the list of the ones that have some likelihood of working is very short. So I'm motivated to look for Phase 1 and 2 (if can could get them) clinical trials. R asked, how do I look .
Occasionally the treating physician will recommend one. That happened to me once. It probably happens more now than it did in my early days.
My first move, when I suspect/know that what I'm on isn't working, is to go to the National Cancer Institute database. I go to clinical trials.gov. (note clinicaltrials.gov is actually the FDA’s database not the NCI’s but I didn’t want to change her original text)
Searching is pretty straightforward if you remember how to use AND's and OR's. You can restrict your search by geographical location (city, state, zip code), by institution name, condition, age group (e.g., NOT children), most things you can think of. If you're not comfortable, your local librarian, among others, will help you.
I evaluate whether I'm obviously excluded (more and more these days, I am, often because of number of prior treatments). And if I'm interested (more on that below) and not obviously ineligible, I email &/or phone. Sometimes the contact listed is at the company, and they'll refer you to the study site. You hope you get to an experienced trial coordinator/nurse. This is all assuming you're comfortable reading and evaluating descriptions of clinical trials. If you're not, find someone who is to work with you. Or put some time into it and develop your skills
What happens next varies, but if this trial seriously looks appealing to you, or the trial coordinator tells you about something else that looks appealing, it ends up with an evaluation at the institution where this trial is running, and recommendations for this and/or other trials at that place. It may be worth a trip out of town if you have the means or insurance coverage for travel, and it's an active research physician in an institution with lots of clinical research going on.
The best place to look at first is, of course, the major cancer treatment center where you're usually treated (or if you're not, the easiest one to get to). Most cancer centers now have Phase 1 departments, which could be called something like "Developmental Therapeutics" or "Phase 1" . You make an appointment and if it's your own institution, you don't need to go through gathering all your records because the Phase 1 doc already has access to them.
Here's an important point: the data base isn't up to date. Even if there isn't a trial that looks good to you at your own institution, go see the Phase 1 doc anyway. Maybe something is about to start or has just started or a slot has just opened up. Phase 1 slots are like Brigadoon. They appear and then disappear. This is because of how Phase 1 trials are structured.
(I once consented at lunchtime, and learned after lunch that the slot had been taken by someone at another institution). Quite normal. (I bolded this because I think it’s an interesting observation).
Same thing for other major cancer centers, especially the big guns, if you can consider going there for treatment (you fly a small plane, your cousin can put you up, you used to live there and all your old friends still do .). Get evaluated and then you will be made aware of what studies you might qualify for. Of course, studies AT the National Cancer Institute, in Bethesda, MD (Washington DC) have plane tickets paid for, at least once you're enrolled in a study, plus some defrayment of other costs.
Or, consider this a second opinion, see the famous guy at Famous Cancer Center, and get her/his recommendations for treatment plus referral to the Center's Phase 1 department. (Though sometimes famous guy just evaluates you for his/her studies, so find out whether there are other studies for which you might be eligible and find out what you need to do to be considered for them, if they interest you.)
Being seen at Phase 1 departments also helps get you on their radar, acquaints you with the nurse/coordinators, with the particular wrinkles of the institution (you know, there is only ONE way to do things and it's the way WE do it. Different everywhere you go.) Then you can call in the future to see whether/what studies that may interest you are going on/about to open up. If time has elapsed, you may need to be seen again to get on the waiting list. There are waiting lists for drugs that are 'hot', like PARP-inhibitors. Again, it isn't all represented in the data base, so talking to the trial coordinator, who knows you, is a faster route to finding out what's happening.
I keep saying "if it interests you". What I mean is I look at whether it's something that there's buzz about, or something that seems to be garnering interest in the literature, how long it's been going on (i.e., not going on, like in 6 years they've accrued only 4 of the 23 subjects they need), what the schedule of treatment is (you can't fly there three times a week, etc), what the side effect profile is, etc. Also where they are at.
Phase 1's enroll patients three at a time, if that functions ok, then three more . until they arrive at the Maximum Tolerated Dose (MTD). Then they enroll an "extension cohort", a number of people whom they give the MTD to. All things being equal, you'd prefer to be part of the extension cohort, just like you'd prefer Phase 2 to Phase 1. Does this study look at biomarkers or do genetic analyses or something besides just round up people who can put a check mark next to "ovarian cancer" or even just "solid tumor"? Studies on
patients with solid tumors (ovarian or lots of other things) could be helpful to you, but all things being equal, seems preferable to go for a study designed to address your type of cancer, or people with characteristics you share (such as a particular mutation).
Consent: Signing consent (aka Informed Consent, aka IC) doesn't obligate you to ANYTHING. It obligates the investigators not to request that you do something the consent says you don't need to. You are ALWAYS free to ditch the study. The PI (principle investigator) is always free to drop you from the study too. But the investigators WANT subjects. They'll only drop you if they determine that the study endangers you, or it clearly isn't working, or their funding is terminated . Of course, don't sign consent if you don't intend to participate in the study!
Before you sign consent, an investigator will tell you about the protocol (what they will and won't do). Listen and ask questions. All things being equal (right, they never are), you'd like a study that allows for dose reduction if needed, you'd like to get a sense that the study will be conducted with serious regard for your welfare. You need to make sure of what to do, whom to call in case of need.
As always, you want to feel confident in the doc and feel that you can communicate, understand and be listened to. Phase 1 docs are usually personable. They can't afford to turn off potential subjects.
This is immensely long, though far from complete, but I want to make sure to add: run the options past your own doc. If you have other docs who know you, a super-brief email asking them for their pick among 2 or 3 options (maybe 3 lines of text?).”
CT lost her life to ovarian cancer, which is a very difficult cancer to treat. Sharing CT’s wise guidance on sorting through clinical trial options.