203241eca8daa010VgnVCM100000ed730ad1RCRDapproved/patient/ASCO Resources/Ask the ASCO Expert/Transcripts/2004 TranscriptsCancer Clinical Trials

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National Cancer Institute

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Food and Drug Administration

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National Coverage Decision

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Food and Drug Administration

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National Cancer Institute

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National Cancer Institute

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www.cancer.net

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American Cancer Society

http://www.cancer.org/

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cancer.gov

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<center>Cancer Clinical Trials Chat Transcript Featured Expert: Richard Schilsky, MD Monday, February 2, 2004 2:00 3:00 PM ET</center> 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 Richard Schilsky, MD. During this hour, Dr. Schilsky will answer as many questions as possible. Due to an increasing number of chat participants and number of questions submitted for each chat event, time simply does not allow us to address all of your questions, and we encourage you to consult your doctor and cancer care team. Some questions may be adapted so that Dr. Schilsky's answers can help as many people as possible. Dr. Schilsky will take questions from 2:00 to 3:00 PM ET. As you prepare your questions, please keep in mind that Dr. Schilsky is unable to give individual medical advice in this setting, nor is he able to address questions that include information specific to one person's medical profile. The information presented here is for informational and educational purposes only and is not intended to substitute the professional medical advice or treatment recommendations provided by your doctor. This forum is neither intended nor appropriate to serve as a means of obtaining a second opinion on cancer diagnosis or treatment. In response to questions about specific drugs, Dr. Schilsky's comments will focus only on the state of current research and clinical trials. It is advised that you do not delay seeking professional medical advice based on any information received during this chat event. The chat is governed by all terms and conditions of the Cancer.Net website. Participation in this chat event means that you fully understand and agree to abide by the terms and conditions of the Cancer.Net website. Good afternoon and welcome. Thank you for joining us. Dr. Schilsky will now begin taking questions. Dr. Schilsky is Professor of Medicine and Associate Dean for Clinical Research, Biological Sciences Division, University of Chicago. An international expert in gastrointestinal malignancies and cancer pharmacology, Dr. Schilsky has served on a number of peer review and advisory committees for the National Cancer Institute (NCI) and has recently completed a term as Chair of the Oncologic Drugs Advisory Committee for the U.S. Food and Drug Administration (FDA). Dr. Schilsky currently serves as a member of the NCI Board of Scientific Advisors. Since 1995, Dr. Schilsky has served as Chairman of the Cancer and Leukemia Group B. He is a member of the external advisory committees of several comprehensive cancer centers, including the University of Alabama at Birmingham Comprehensive Cancer Center, the Mayo Clinic Cancer Center, and the Cancer Institute of New Jersey. He has also served as a member of the Selection Committee for the Bristol-Myers Squibb Award for Distinguished Achievement in Cancer Research. Dr. Schilsky is an Associate Editor of Clinical Cancer Research and Cancer and a member of the editorial board of Seminars in Oncology and the Journal of Cancer Research and Clinical Oncology. He has published more than 170 articles and book chapters in the medical literature. Dr. Schilsky, thank you for taking the time to join us today. Would you like to make any opening remarks? Dr. Schilsky: Clinical trials are the tools used by physicians and researchers to develop new drugs and devices for cancer treatment and prevention. A clinical trial is an experiment involving people with cancer or individuals at risk of developing cancer that seeks to learn about the side effects, effectiveness, and benefit associated with a new cancer treatment and to determine how to best integrate a new treatment into standard medical practice. All standard cancer treatments were considered experimental at one time in their development and only became standard when they were proven, by clinical trials, to be safe and effective treatments. Participation in a clinical trial is completely voluntary but should always be considered as an option in the care of people with cancer. It is appropriate to consider a clinical trial whenever a decision is made to begin or change cancer treatment. Different types of trials are more or less appropriate for patients with different types of cancer, different stages of cancer, and different functional levels. Newly diagnosed patients may wish to consider the option of a phase III, or randomized, clinical trial that compares standard treatment to a promising, but as yet unproven, alternative. Patients who are no longer benefiting from standard cancer treatment might wish to consider the option of a phase II or phase I trial. These studies usually test new drugs to determine whether they can shrink or slow the growth of cancer and what their side effects are. Patients may or may not directly benefit from participation in a clinical trial. Participation in a randomized clinical trial generally assures that patients will at least receive the currently accepted standard of care administered under the most carefully controlled circumstances. Participation in early phase clinical trials gives patients the option to receive a new treatment that may or may not ultimately be proven to be effective but which would not otherwise be available. Since there are many safeguards built into clinical trials, the risks of participation in a trial are rarely greater than those associated with receiving standard cancer treatment. Most cancer clinical trials are developed by physicians and researchers working collaboratively with the <a target="_NEW" href="http://www.cancer.gov/">National Cancer Institute</a> or by experts in the pharmaceutical industry who work under the oversight of the <a target="_NEW" href="http://www.fda.gov/">Food and Drug Administration</a>. These trials are widely available at cancer centers, community hospitals, physician networks, and individual physician offices. It is now uncommon for patients to have to travel far from home to find an appropriate clinical trial for their type of cancer. Patients should speak with their physicians about the availability of clinical trials in their communities. Many reliable Internet sites also provide information about clinical trials and where to find them. Among the most useful are: <a href="http://www.cancer.net/">http://www.cancer.net</a> <a target="_NEW" href="http://www.trialcheck.org/cancertrialshelp/cancertrialshelp.aspx">http://www.trialcheck.org/cancertrialshelp/cancertrialshelp.aspx</a> <a target="_NEW" href="http://www.clinicaltrials.gov/">http://www.clinicaltrials.gov</a> Clinical trials are vital to developing new cancer treatments. Rapid enrollment of trials will lead to answers more quickly about which treatments work and which should be discarded because they are not effective or have too many side effects. Although precise numbers are hard to come by, it is estimated that more than 50,000 people with cancer participate in clinical trials each year that are offered by thousands of oncologists at locations across the country. The options for people with cancer are greater than ever before, and patients should learn as much as possible about their options before deciding on a treatment program. Patients have little to lose by selecting the option of a clinical trial and there is much to be gained by completing trials as quickly as possible so as to increase the rate of progress in finding new and better treatments for patients living with cancer. hollyh: Why do so few adults participate in cancer clinical trials? With such low numbers, how can new treatments be tested with the accuracy it takes to become approved? Dr. Schilsky: Sometimes patients do not meet the criteria for entry into a trial, or find that their social and family commitments would make it difficult for them to meet the requirements of participating in a trial. It is important that as many patients as possible participate in studies so that we can get answers as quickly as possible. DohBoy: Can you comment on the role of placebos in clinical trials? Why would a patient enroll if there were a high likelihood that he/she would receive a placebo? Dr. Schilsky: It is rare that placebos are used in cancer clinical trials. In almost all studies, patients can be assured of receiving active treatment. On some occasions it may be necessary to use a placebo to determine whether a new drug adds to the effectiveness of standard treatment, but even in those cases, patients will always be receiving the standard treatment for their disease. ff3565: Can you please speak to the safety of cancer clinical trials? What special considerations are made for children? Dr. Schilsky: There are many safeguards in clinical trials. Most clinical trials are developed by experts and carefully reviewed by regulatory agencies such as the <a target="_NEW" href="http://www.cancer.gov/">National Cancer Institute</a> or the <a target="_NEW" href="http://www.fda.gov/">Food and Drug Administration</a>. During the conduct of clinical trials, patients are carefully monitored for adverse events and, in many trials, independent data and safety monitoring boards review data from the trial to be sure that patient safety is not jeopardized. There are many cancer clinical trials designed specifically for children that take into account the unique physiology and behavioral characteristics of children. Guest30: I want to participate in clinical trials, but my insurance company will not cover all of the costs. Are there any agencies that help defray the out-of-pocket costs to patients? What about travel expenses? Dr. Schilsky: Most patient care costs in clinical trials are reimbursed by insurance companies. Specific experimental drugs are often provided for free. President Clinton issued the <a target="_NEW" href="http://cms.hhs.gov/coverage/8d2.asp">National Coverage Decision</a>, which requires that Medicare cover the cost for participation in clinical trials. Some national agencies like the <a target="_NEW" href="http://www.cancer.org/">American Cancer Society</a> may offer services to patients to help defray some of their expenses for participating in clinical trials. Guest33: Can you please explain informed consent? Dr. Schilsky: Informed consent is a process during which researchers discuss with patients the pros and cons of participating in a clinical trial. The doctors describe what treatment will be used, what the side effects will be, what the alternatives are to participation, and what recourse patients have if they have been injured during participation in a study. After this discussion, patients are asked to sign a consent form that contains all of the information about the trial. This form has been reviewed and approved by a committee called the Institutional Review Board (IRB). The IRB is a committee of physicians, lawyers, clergy, and lay people that reviews the risks and benefits of a clinical trial and gives approval to conduct the study. Guest18: A recent article hypothesized that drug companies are in ultimate control of the cancer cures and hold back when releasing drugs so as to control the money aspect and become richer and richer. The article said that there could be more cures available now if the drug companies would release information. What is your opinion on this? Dr. Schilsky: Drug companies have little incentive to withhold information about new cancer treatments. Their goal is to bring safe and effective treatments to the market as quickly as possible. They have an obligation to conduct high quality clinical trials and to make the results known as soon as possible after the trial is completed. The FDA carefully monitors the clinical trials conducted by drug companies to be sure that they are done properly. Guest0: Are there clinical trials for rare types of cancer? And, if my cancer is so rare that my physician has to refer me elsewhere, how can I become involved in a clinical trial? Dr. Schilsky: It is difficult to conduct clinical trials for rare tumors simply because there may be too few patients with that kind of cancer to complete a trial in a timely fashion. Drug companies have relatively little incentive to conduct studies of rare tumors because the potential market in those diseases is small. However, other government-funded research groups, like the cooperative groups, will often study rare tumors because of the importance of finding new therapies. Guest71: Are there any services where patients can post their medical information in the hopes that clinical trials coordinators will seek them out? Dr. Schilsky: Not that I know of, but there is a website called <a target="_NEW" href="http://www.trialcheck.org/cancertrialshelp/cancertrialshelp.aspx">www.trialcheck.org</a> where patients can enter their clinical information to find a clinical trial that is appropriate for their case. pdavis: If I participate in a clinical trial, what happens after the trial ends? How will my normal treatment resume? Will my regular doctor be notified of my results or progress? Dr. Schilsky: Patients usually continue to participate in a study until their disease progresses or they complete the required course of treatment. Once the trial is over, patients should discuss with their doctors whether or not any additional treatment is necessary. Doctors learn the results of clinical trials by attending medical meetings, by reading medical journals, or by participating in various medical education programs. Sometimes, the research group that has conducted the study informs doctors directly about study results. Veronica: There have been reports that state that older patients do not receive as aggressive treatments as younger patients. What is your view on this issue? Dr. Schilsky: It is true that older patients may not be treated as aggressively as younger patients, but the reasons for this are largely due to misconceptions by physicians. Where it has been studied, it is clear that older patients benefit as much as younger patients from chemotherapy. Sometimes older patients have slightly more side effects than younger patients, so they need to be monitored closely during treatment. But the available evidence suggests that fit older patients should be offered chemotherapy and are likely to tolerate it well. del: I want to be in a clinical trial, but I'm not sure how to interpret the eligibility requirements. What can I do to understand this language better? Dr. Schilsky: Eligibility requirements are a list of criteria that patients must meet to participate in a clinical trial. These criteria generally include blood test results, information about previous treatment, and an assessment of the patient's functional status. Eligibility criteria are necessary for the safety of patients and to help researchers interpret the results of the study. CateB: Is it possible to be too sick to get into a clinical trial? Dr. Schilsky: Yes. Sometimes patients who are very sick are at high risk of severe side effects from cancer treatment. Since clinical trials often study new drugs, whose side effects are not well known, it may be unsafe for very sick patients to participate in a study. Guest2: My mother's physician has recommended that she participate in a clinical trial, but she is concerned that she will not receive any individualized attention. How can I ease her fears? Dr. Schilsky: Nothing could be further from the truth. Because clinical trials are so carefully monitored by various regulatory agencies, patients who participate in trials often get even more attention than is customary to be sure that the protocol is followed correctly and that patient is monitored carefully for side effects. Guest35: How can someone currently living outside of the United States participate in a clinical trial in this country? Dr. Schilsky: That's difficult. There are clinical trials available in many countries around the world; drug companies sponsor some of these, others are sponsored by local government agencies. There are some US clinical trials that are available to collaborators in Europe. The US <a target="_NEW" href="http://www.cancer.gov/">National Cancer Institute</a> will have a list of such trials. MarthaW: Can healthy people participate in cancer clinical trials? Dr. Schilsky: People who are at high risk of developing cancer but who do not have cancer are good candidates to participate in cancer prevention trials. Many such trials are going on for prevention of breast cancer, prostate cancer, colon cancer, lung cancer, and skin cancer. David01: Can you explain the different phases of a clinical trial? Dr. Schilsky: Certain information is necessary to develop a new cancer drug. The first thing we need to know is the right dose and the side effects of the treatment. Phase I trials are designed to obtain this information. Next, we need to know if the drug can either shrink tumors or slow down their growth. This information comes from phase II trials. Finally, we want to know how a promising new drug compares to the current standard of care. This information comes from randomized phase III trials. Once a new drug completes all phases of testing, we know whether FDA should approve it for widespread use. Guest93: I am in a clinical trial right now and am convinced that I have been given the older drug being tested as opposed to the newer drug other participants are on. What can I do? I am considering removing myself from the study and seeking another alternative to assure I get the best treatment. Dr. Schilsky: The older drug most likely represents the current standard of care, so you can be assured that you are receiving the best currently available treatment. While the newer drug seems promising, the purpose of the trial is to prove that the newer treatment really is better than the standard. We can't know that until the trial is completed. If you are uncomfortable with receiving your current treatment, you should discuss other options with your doctor. otto: Can you be involved in more than one trial at a time? Dr. Schilsky: Sometimes. Usually, you can only be in one treatment trial at a time. Sometimes it is possible to participate in a treatment study as well as a study of new supportive care medicines, or a study of quality of life while also participating in the treatment study. m4treetment: Where can I find more information about specific clinical trials? Dr. Schilsky: First, consult with your physician. There are various Internet sites that provide information about cancer clinical trials, such as <a href="/vgn-ext-templating/v/index.jsp?vgnextoid=4327438bc8957110VgnVCM100000ed730ad1RCRD" alt="trialcheck.org">Trialcheck.org</a>, or <a target="_NEW" href="http://www.cancer.gov/">cancer.gov</a>. You can also call the Cancer Information Service at 1-800-4-CANCER. 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. We want to thank Dr. Schilsky for lending us his time and expertise. TRANSCRIPTS: The full text of today's chat will be available on Cancer.Net (<a href="http://www.cancer.net/">www.cancer.net</a>) tomorrow by 12:00 PM ET. To receive a copy of the transcript by e-mail, please send a message to <a href="mailto:contactus@cancer.net">contactus@cancer.net</a>. SAVE THE DATE: Please join PLWC for a live chat about Cancers in Women on Thursday, February 19, from 3:00 to 4:00 PM ET. The featured expert is Maurie Markman, MD, Vice President for Clinical Research, M.D. Anderson Cancer Center. The chat room is now closed. Thanks again for joining us.

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