Cancer Clinical Trials

Cancer Clinical Trials Live Chat with Robert L. Comis, MD
Monday, March 17, 2003, 4:30 - 5:30 PM ET

Moderator:On behalf of the American Society of Clinical Oncology (ASCO), welcome to the Cancer.Net chat on cancer clinical trials, a live question-and-answer session hosted by Robert L. Comis, MD. During this hour, Dr. Comis will answer as many questions as time permits. Some questions may be adapted so Dr. Comis's answers can help as many people as possible.

Dr. Comis will take questions from 4:30 PM to 5:30 PM ET. As you prepare your questions, please keep in mind that Dr. Comis is unable to give individual medical advice in this setting. In answering questions about specific drugs, Dr. Comis's comments will focus on the state of current research and clinical trials.

Good afternoon, and welcome. Thanks for logging on. Dr. Comis will now begin taking questions.

Robert L. Comis, MD, President and Chairman of the Coalition of National Cancer Cooperative Groups, Inc., is Professor of Medicine and Director of the MCP Hahnemann University Clinical Trials Research Center, Philadelphia, and the Group Chair of the Eastern Cooperative Oncology Group (ECOG). A leader in national clinical trials research since 1977, Dr. Comis has been actively involved in increasing the awareness of the pivotal role cancer clinical trials have in cancer treatment.

Dr. Comis holds an elected position on ASCO's Board of Directors. He was appointed Chair, Clinical Trials Team of the National Dialogue on Cancer (NDC) and was elected to the Board of the American Radium Society (ARS) and the National Coalition for Cancer Research (NCCR). Dr. Comis is a Diplomate of the American Board of Internal Medicine, a member of the International Program Committee of the American Radium Society, and Chairman of the Nominating Committee of the American Association for Cancer Research, Inc.

Dr. Comis, thanks for making the time to join us today. Please begin by telling us a bit about why cancer clinical trials for adults and children with cancer are so important.

Dr. Comis: I really appreciate the opportunity to participate in this live chat. Clinical trials represent the engine for the discovery of new treatments for cancer. As a result, increased participation is really critical. Right now, it appears that only 3%-5% of adult cancer patients participate in trials. There are over 400 new compounds/drugs available for testing. If adult participation remains at such a low level, it will take a long time to bring new treatments to patients in the United States and throughout the world.

Interestingly, participation of children with cancer through the good graces of their parents is remarkably higher than the adult level, probably closer to 60%-70%. Many of us, including pediatric oncologists, believe that the tremendous increase in survival seen in pediatric cancer is very much linked to the clinical trials process and opportunities.

Toby: I work for a county health department, and I know a lot of people who are worried about placebos. Can you comment?

Dr. Comis: This is a very important question because there is a great misconception on the role of placebos in cancer clinical trials.

In treatment-oriented clinical trials, we would never design a study that uses a placebo in lieu of the best available standard of care. At a minimum the "control arm" always includes the best available standard of care. I run a clinical trials group called the Eastern Cooperative Oncology Group (ECOG). Less than 10% of our trials include a placebo. When it is used, it is always in conjunction with the best available standard of care and compared to the best available standard of care with a new approach.

It's a little different for cancer prevention trials, where we are trying to establish where effective means of cancer prevention occur. Often times, the initial trials might use a placebo, but once a cancer prevention method is found to be effective, that new method becomes a standard for which everything else is compared. The best example is the use of tamoxifen in the treatment of breast cancer.

The same will now be true with aspirin in the treatment of colon cancer, which has been unequivocally shown in the last few weeks to be able to prevent colonic polyps.

Brendan: What is a phase I trial? Do people ever actually get better from being on these trials?

Dr. Comis: A phase I trial is primarily designed to determine the side effects of a particular dose and schedule of a new drug or treatment. Probably only about 5%-10% of those who enter trials are entered under phase I studies.

Those patients tend to be the ones that the best available treatment is no longer effective. The way the studies are designed is to use the fewest patients to get to the right dose and schedule so that patients who have a better risk profile can be treated in a phase II trial, where the activity of the treatment is desired.

All phase I studies are performed with drugs or new treatments with a lot of promise, but the primary purpose is to establish the side effects and safety profile. In the past, it has always been pretty unusual for patients to respond in the phase I setting. Recently we have had unusual experiences with drugs such as the new signal-transduction inhibitors for the treatment of chronic myelogenous leukemia (CML), for instance.

Tom: My father, who has stage IV pancreatic cancer, was told that he didn't qualify for a clinical trial because he has had chemotherapy before. Why might that have happened?

Dr. Comis: In recent years, some types of treatments including chemotherapy have been approved for use in pancreatic cancer. These include 5-FU and more recently gemcitabine. Because of these Food and Drug Administration (FDA) approvals, many doctors and patients decide to use such treatments first.

This is part of the delivery of the best existing standard of care. Many clinical trials that try to establish a new first-line approach to treatment of necessity exclude patients who have already had first-line treatment.

On the other hand, there are treatments being developed for patients who have already had first-line therapy. There is a excellent pancreatic cancer support group called PanCAN, which works very closely with our Coalition of National Cancer Cooperative Groups, which tries to match pancreatic cancer patients with appropriate cancer clinical trials. Their website is www.pancan.org.

Guest105: I've been following the story of the gene therapy trials in France. Are those trials stopped? Are similar trials being done in the United States?

Dr. Comis: To my knowledge the trials have been suspended both in the United States and France.

roscoepjones: Do you have to live near the National Cancer Institute (NCI) to be in a trial?

Dr. Comis: This is a question which is so important. It represents a huge misperception on the part of the public relative to the availability of cancer clinical trials. In the United States Cooperative Group system, we have over 6000 doctors and staffs throughout the country performing cancer clinical trials. These trials are performed in excellent community centers as well as in academic centers.

For patients who are eligible for phase III studies (85% of all), trials are available in many, many communities throughout the country. Over 60% of all patients entering clinical trials in the United States are treated in excellent community practices.

So, it is important to ask in the community setting whether or not your team is involved in clinical trials. Also, there are certain websites where you can try to find trials in specific regions. Right now, the major site is http://clinicaltrials.gov.

We in the Coalition will be launching a search engine called TrialCheck® for the public within the next few months. Also you can use Cancer.Net (www.cancer.net) to link with our site and other sites.

AnneL: Do drug companies have to follow the same rules when conducting research as in universities or National Institutes of Health (NIH)-funded studies?

Dr. Comis: Once again, this is a great question. Drug company trials for new approaches to cancer are required to have FDA approval, so the FDA tends to be the primary governing agency involved in the oversight of these trials. That oversight is extensive and very similar to the oversight that occurs in government-sponsored studies.

The pharmaceutical industry is an extremely important cancer drug development force for our nation and the world. The most important thing is for a patient and his or her family to determine who the sponsor of the given clinical trial is and what type of oversight is involved in that clinical trials process.

HannahGrace: What is happening with the Study of Tamoxifen and Raloxifene (STAR) trial?

Dr. Comis: The STAR trial continues to accrue patients at an excellent rate. As I understand it, about 3000 more patients are required to complete entry onto the trial. It's very important that the momentum continue. Sometimes the hardest part in the accrual process occurs towards the end so we all remain extremely committed and interested in making sure that the STAR trial is a success.

suem: Can you tell us a little bit about the Coalition and its accomplishments?

Dr. Comis: We established the Coalition of National Cancer Cooperative Groups about five years ago. The major cooperative groups are not-for-profit foundations together under the banner of the coalition. We did this in order to more effectively interact with the multifaceted interested clinical trials and cancer community.

We have launched several major programs in those five years. We are now in our third year of a major national awareness campaign trying to bring a strong and balanced educational message in partnership with Newsweek and The Washington Post Corporation. Another initiative is the development of our search engine, which provides the only search engine capability that can link doctors and their patients with IRB- approved sites. This is called TrialCheck®, and it was made available first to doctors, next to patient advocates, and finally will be available to the public within the next two months.

As part of our educational web-based approach we launched an educational website called cancertrialshelp.org. You can get there either directly or through Cancer.Net.

The third major initiative was to engage the patient advocacy community in an important collegial way. Currently over 30 patient advocacy groups are associate members of the Coalition. We have established a new patient advocate training program and this will soon be available on the web for the public.

roscoepjones: What happens if I get sicker during a trial?

Dr. Comis: Participation in a clinical trial represents an important pact between the doctor and the patient. Before entering a trial there is a process called the informed consent process. This is to ensure that the participant is aware of the potential risks and benefits of treatment.

If in the course of a clinical trial a patient, or the patient and his or her doctor, decides that the side effects of the treatment are severe or are associated with significant discomfort, the patient can decide to no longer be involved in the trial.

The research participant always has the option of withdrawing at any time. It should be emphasized, though, that there are certain reasons that the decision was made to participate in the beginning. Once again, it is a key discussion and decision-making point for the person participating in the trial and his or her doctor.

lakerfan: What is "IRB?"

Dr. Comis: I'm sorry that I'm using jargon. IRB is an abbreviation for Institutional Review Board. These boards are comprised of individuals of varying backgrounds who review, approve and monitor clinical trials at an institution. In order for a trial to be approved for use, IRB approval must be obtained.

For all federally sponsored trials, the IRB and its activities must be approved by a government agency called the Office for Human Research Protection, under the Department of Health and Human Services.

Jamie: How can I find out the results of a clinical trial I participated in?

Dr. Comis: One avenue of approach is to ask the doctor who was involved in your treatment whether the results are currently available to the cancer research community and public. In the cooperative groups, we are developing methods to provide exactly that information to patients who have participated. This is a work in progress.

I think that there is a growing interest on the part of the cancer research community to provide this information. The patient advocates involved in cancer clinical trials research have been a major source to help move this issue along.

Julia: I have stage III breast cancer and seem to be eligible for several trials. Is there a limit to the number of programs I can join?

Dr. Comis: There are certain eligibility requirements that are associated with the entry into any clinical trials. The reason for such requirements relates to the need on the clinical research side to address a specific problem in a specific patient group, and also to make sure that there aren't any undue side effects associated with treatment.

In general, an individual can only participate in one treatment trial at any given time. The problem, particularly in the information age, is that a person may have a long list of trials and not be certain which one might be most appropriate for them. In the end, it has to be a decision between you and your doctor. Getting that advice and counsel is very important.

The search engines that we are trying to develop are trying to help narrow the list and point individuals to trials that are most appropriate to them. We're trying to do that in a way that is simple.

Guest157: Are trials conducted on children different than those conducted on adults?

Dr. Comis: The clinical trials process and the phases of clinical trials development are pretty much the same in children and adults. The parents are obviously key in the decision, along with the child. That's a major difference. Another difference that might appear subtle, but is probably very important, is that most developers of new drugs design the initial trials with adults in mind.

Often times, the newer drugs are not made available in the initial phases to childhood patients and their doctors. The entire children's clinical cancer research community is committed to making sure kids have the same opportunities as adults.

Cara: My mother (she has colon cancer) worries that because they will use a preset drug regimen on a clinical trial, she won't get personalized care. Is this true?

Dr. Comis: No. In fact, the treatment regimens that are laid out in a clinical trial represent an important standardized approach to care. In addition, in a clinical trial there is a very well defined method for following both side effects and therapeutic effects so adjustments can and are made throughout the course of treatment. As well, the doctor can make adjustments at any time he or she considers it in the best interest of patients. So, if anything, the clinical trials methodology helps standardize the quality of care throughout the country.

Moderator: The chat is now ending. Thank you for your thoughtful questions. We hope this discussion has been valuable, and we regret not being able to answer every question. Dr. Comis, thanks again for lending us your time and expertise.

TRANSCRIPTS: The full text of today's chat will be available on Cancer.Net (www.cancer.net) by 5:00 PM ET tomorrow. To receive a copy of the transcript by e-mail, please send a message to contactus@cancer.net.

For more information on cancer clinical trials, visit the Coalition of National Cancer Cooperative Groups, Inc., at www.cancertrialshelp.org. Cancer.Net (www.cancer.net) also has information on cancer and clinical trials.

SAVE THE DATE: On April 11, 2003, Cancer.Net will feature Bernard Levin, MD, for a live chat about cancer prevention. The chat will be from 2:00 to 3:00 PM ET. Dr. Levin is Vice President for Cancer Prevention at the University of Texas MD Anderson Cancer Center.

The chat room is now closed. Thanks again for joining us.