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Phase I Clinical Trials: Advancing Cancer Treatment


Oct. 27, 2008 – A. Craig Lockhart, MD, MHS, leader of Siteman Cancer Center's developmental therapeutics program, discusses phase I clinical trials and how they are critical in bringing new approaches to treating cancer to current and future patients.

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On this edition of Cancer Connection, we will talk about developmental therapeutics: What the process is and how this research is leading to a more targeted approach to cancer treatment.

Host: Thanks for downloading this podcast from the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St Louis. I’m Jason Merrill. Just about every drug regimen used in cancer treatment started as a clinical trial. Oftentimes, developmental therapeutics plays a role in the process of bringing cancer therapies from the bench to the bedside. To tell us more is Dr. Craig Lockhart. He is director of the developmental therapeutics program at the Siteman Cancer Center. Dr Lockhart, thank you for joining us.

Lockhart: Thank you for having me.

Host: Well, let’s start at the beginning. What is developmental therapeutics?

Lockhart: Developmental therapeutics is a broad category of clinical trials. Clinical trials are studies in patients where we’re trying to evaluate new therapies. So in developmental therapeutics, we’re generally looking at new drugs and, first of all, how these drugs behave in the body, what kind of side effects they have and what is the safe dose of these drugs. Then later on, do these drugs really work in cancer? So as part of the developmental therapeutics program, we have what we call early clinical trials looking at brand-new drugs that have never been evaluated in people before. We also look at new drug combinations because when a drug is being developed, we have to find out whether this drug can be safely combined with other chemotherapies that are already out there. And so a lot of our studies are looking at these brand-new drugs or looking at these brand-new drugs in combination with some older drugs.

Host: And how do these studies advance cancer treatment?

Lockhart: So every cancer treatment that's out there has been evaluated in these early phase clinical trials or these developmental therapeutics clinical trials. If you go to your doctor and your doctor recommends a chemotherapy for you, this chemotherapy has been through the kind of testing that I’m now discussing. What we're trying to do in addition to just developing new drugs is trying to get the older drugs to work better for us. This is what we refer to as personalized medicine. Sometimes we do tests on the tumors to try to come up with pathways the tumor may use for growth and to see whether those pathways can be exploited so that we can target the tumor little bit better and treat patients in more of a customized way. So we're treating their tumor in a particular way and not just treating all tumors the same way. Also, sometimes we do genetic testing on the patient because sometimes that can also give a clue into what drugs may work best for that patient and also ways that we can possibly reduce side effects for those particular patients.

Host: These types of personalized care that you mentioned, how are they being applied now and will they be applied more often in the future?

Lockhart: So we’ve done a few studies here at Washington University looking at these personalized approaches to cancer treatment. I have one particular study right now where we draw blood and we test somebody’s genotype for particular protein that the chemotherapy drugs can work on. If you have a particular genotype, you may be sensitive to this chemotherapy drug, and it may be a good drug for you. If you have a different genotype, your tumor is likely resistant to that chemotherapy, so we need to treat you with something else. There are other similar studies like that that are ongoing.

Host: This really is an important area of cancer research, isn’t it?

Lockhart: Absolutely. We can't treat patients with a one-size-fits-all attitude. Cancer chemotherapy drugs have too many side effects for us to find the right dose through trial and error. And it's too serious of a disease for us to treat people with a drug that is going to be ineffective for them. So I think personalizing care is really a wave of the future.

Host: Overall, how important is it for a patient to enroll in clinical trials?

Lockhart: All the advances that we make in medicine are based on clinical trials. Things as simple as learning to use aspirin in patients who have had heart attacks required clinical trials. Every advance in medicine requires that we do these clinical trials, and so I think it's very important that patients participate because it helps us to advance science and helps us to advance treatments for every disease. And of course, my interest being cancer, it helps us to advance new drugs and new therapies in the fight against cancer.

Host: Dr. Lockhart, thank you for joining us.

Lockhart: Thank you for having me.

Host: For more information about cancer clinical trials, you can visit the Siteman Cancer Center online at or call 800-600-3606. Thanks for downloading. Until next time, I’m Jason Merrill.