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Clinical trials are often the key to advancements in treating ovarian cancer. As part of its “Speaking Out” video series, CURE® spoke with Dr. Debra Richardson about what patients should know about joining a trial.
Many advances have been made in treating ovarian cancer treatment, such as the development and use of maintenance therapy in the past decade. Clinical trials made these developments possible, and patient participation and awareness of clinical trials are vital to their success.
On behalf of the National Ovarian Cancer Coalition, CURE® spoke with Dr. Debra Richardson, a gynecologic oncologist at the Stephenson Cancer Center and associate professor at the University of Oklahoma College of Medicine in Oklahoma City, about clinical trials in ovarian cancer, and what patients should know if they are interested in joining one.
Richardson: There are lots of clinical trials going on right now trying to address every problem imaginable in ovarian cancer. We’re looking at screening tests. We’re looking at early diagnosis tests. We’re looking at better treatments, treatments that will hopefully result in better cure rates. We’re looking at new maintenance therapies. We’re investigating immunotherapy. So, really, every avenue of ovarian cancer.
For recurrent ovarian cancer, we separate patients into platinum-sensitive and platinum-resistant groups. And that has to do with how long it’s been since a patient’s last platinum (chemotherapy treatment). If it’s less than six months, they’re considered platinum-resistant. If it’s more than six months, they are considered platinum- sensitive. We’re investigating how to maximally treat those patients, as well, and find new drugs to get approved so that we can continue to treat patients with ovarian cancer.
The National Cancer Institute recommends that all patients with cancer who are eligible for clinical trial be offered one. Unfortunately, we know that’s not the case. And, in fact, about only 5% or so of (adult Americans with cancer) go on clinical trial. I think we have a lot to learn from our pediatric colleagues. More than 60% of children diagnosed with cancer go on clinical trial. If you look in the past, pediatric cancers were mostly lethal. Now there’s a more than 85% cure rate. And that is from high participation in clinical trials. That’s the only way to move the needle forward and find better treatments and increase the cure rate.
How can patients learn more about a clinical trial that they might be eligible to join?
(Patients) should definitely talk to their physician, and hopefully their physician can give them information about clinical trials. There’s also clinicaltrials.gov, where patients can put in their type of cancer, where they live and how far they might be willing to travel to see what types of clinical trials are potentially available. And then if they find some, they should contact the institution that’s running that trial and speak to one of the clinical research nurses and get more information.
Clinical trials are not a one-patient-fits-all (approach). (Patients) might find something online that you think is really exciting or interesting but is not the appropriate clinical trial for you, for whatever reason. Your physician will know about your particular case, your diagnosis and whether a clinical trial may be a good fit for you. (Your physician) can also put it in context of what is the current standard of care and what are the potential risks and benefits of that clinical trial.
The guinea pig (misconception is one) I hear a lot. But the truth is, guinea pigs don’t have any say, they’re just put in a cage and given drugs. Human beings have a say. We do what’s called an informed consent where we have a conversation about risks, benefits and alternatives. You have the right, if you participate in a clinical trial, to revoke consent at any time and withdraw from the trial if you don’t think it’s the right fit for you.
Now, obviously, we don’t want a lot of people to sign up for clinical trials and then not complete them. But there are certainly rights that are respected for humans participating in clinical trials.
Regarding the placebo (misconception), the only way that you would ever be randomized to a drug versus placebo is if the placebo is the standard of care. In other words, when we were first looking at maintenance therapy for ovarian cancer, the standard of care was that after you completed chemotherapy (you would) not get any further treatment. And that’s how it was ethical to give placebo only, because we didn’t know if the other drug would be beneficial. Drugs certainly have the potential for side effects. The only way to really investigate what is the benefit from the drug we’re giving you (is to use) a placebo because we know when we put people on clinical trials, they actually do better than patients (not on a clinical trial), even if they only get the standard care on the trial. They tend to do better on clinical trial than if they get sooner care off trial. We’re not entirely sure why that is, but it may be all the extra visits or monitoring that you get on a clinical trial that you may not get ordinarily, for example.
In clinical trials, when you’re talking about being potentially randomized, that means either a flip of a coin or, if there are three arms, it might be picking straws, in that you don’t choose and your physician doesn’t choose. It’s generated by the computer randomly so that we can try to control for factors that we’re not aware of that might affect the study’s outcome. The only way that you’re getting on a clinical trial such as that is if it’s standard-of-care versus our new drug.
I would say definitely discuss it with your physician. See what your options are. You’re given a consent form when you’re considering a clinical trial. They tend to be long, about 20 to 25 pages. I definitely recommend that you read through it. They are supposed to be written in a language that the average patient can understand. Involve your family members or your caregivers in that decision, as well. Make a list of questions and make sure that all your questions are answered to your satisfaction.
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