Wilshire Oncology Medical Group, Inc. This consent form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision. Introduction This consent form describes the purpose, the number of subjects, procedure, benefits, possible risks, discomforts, and precautions associated with the study. It describes alternative treatments that are available to you and your rights as a subject. No guarantees or assurances can be made regarding the results of this study. It is essential that you be completely truthful about your past health history and any symptoms you may experience during the study. If you are not truthful, you may harm yourself by participating. Background Purpose Number of Subjects Study Treatments Study Procedures It is possible that after these tests are reviewed, you will not be able to take part in this study. If you are not eligible, your study doctor will discuss other treatment options with you, If these first examinations show that you are eligible for the study, and you decide that you wish to participate in this clinical study, you will be given BMS-247550. All subjects who receive an infusion of BMS-247550 will be given medications before the infusion to try to prevent an allergic reaction. These medications may include diphenhydramine (Benadryl®) and Tagamet® or Zantac®. All subjects will receive treatment as an outpatient. A temporary plastic catheter (tube) will be inserted in a vein in your arm for receiving BMS-247550. In some cases, your study doctor may use a central venous catheter or port (a tube-like device usually inserted into a large vein in the chest that allows fluids to flow into the vein and blood to be taken out). If your study doctor recommends a central catheter be placed, it will be discussed with you in a separate consent process. Before each treatment, you will have a physical exam, including a nervous system, vital signs (blood pressure and pulse rate), and blood work. You should report any side effects that you may have noticed since the previous appointment. You will need to have routine blood work (about 2 tablespoons) weekly. If you have low blood counts, your study doctor may ask you to have blood work done more often until they are normal. This can be done near your home. CT scans, MRIs, x-rays, and/or ultrasound appropriate to evaluate your disease and safety of the treatment, will be done after every two cycles of treatment until the end of your treatment. Your study doctor may decide to do some tests more often in order to monitor safety or to evaluate treatment response. Before and during the administration of BMS-247550 your vital signs will be monitored. You may continue to receive your treatment until there is evidence that your disease is becoming worse or you are experiencing severe side effects from the study treatment. Typically, the maximum length that you will be receiving therapy will be approximately one year. Additional information will be collected about your disease status and any other treatments. The expected length of your participation in this study will be approximately 2 years. After you have stopped your treatment, you may need to return to your study doctor for any unresolved side effects. These visits may include laboratory testing or other appropriate tests. The study staff will also continue contacting you after the study is over to evaluate your cancer status and any cancer treatment you may be receiving. Your Responsibilities At each visit: Additionally, over-the-counter medications or medications prescribed by other doctors may affect how you react to study medications. Therefore, it is important that you inform your study doctor involved in this study of all medications as well as any herbal or natural products you are taking before entering the study, as well as any medications you may need to start taking while you are on the study. You should report any side effects or discomforts to your study doctor. Many times, your study doctor can prescribe medications to help control some of the side effects described below. Most side effects will subside once treatment has been completed. Risks/Possible Adverse (bad or harmful) Drug Reactions If you experience severe side effects associated with BMS-247550 your study doctor may prescribe medication, future treatments may be delayed, the dose of study drug may be reduced, or treatment may be stopped permanently. BMS-247550 may cause the side effects listed below. This information is based on the use of BMS-247550 in subjects in other clinical studies. In addition, since BMS-247550 is investigational, there may be side effects that are not yet known that may occur. You should tell your study doctor or study nurse about any side effects you experience.
Your condition may not get better or may become worse while you are in this study. Risks for Women of Childbearing Potential: WOMEN You cannot participate in this study if you are or plan to become pregnant, or if you are breast-feeding. There may be unknown risks to you, the embryo/fetus, or nursing infant if you become pregnant during the study. You must be using adequate contraception for the length of the study. During the study you will have pregnancy tests done every third cycle until study completion. If you become pregnant, suspect pregnancy, if you have a change in your menstrual cycle, or in your contraception method, you should immediately contact your study doctor. Should you become pregnant during the study, you will be withdrawn from the study immediately and should seek obstetric care. The sponsor will not be responsible for providing routine medical care relating to your pregnancy. In the case of a pregnancy your study doctor will ask you to agree to allow access to your medical records and to the medical records of your infant for a minimum of eight weeks after delivery. It is not known what, if any, risk BMS-247550 presents to the embryo or fetus. You must not become pregnant during treatment with BMS-247550. If you are sexually active, you must practice effective birth control (your study doctor will discuss with you what methods of birth control are considered adequate, if appropriate). A pregnancy test will be done before you start receiving BMS-247550, and will be repeated periodically during the study. If you become pregnant during treatment with BMS-247550, treatment will be discontinued immediately, you will be referred for obstetrical care and the responsibility for obstetrical, and child or related care will be yours. You must let your study doctor or study nurse know immediately (see telephone number listed below), if you suspect that you may be pregnant (for example, if you have missed a period or have had a change in your periods), or if you are planning to change your method of birth control. In the event that you become pregnant during treatment, BristoI-Myers Squibb (the company sponsoring this research study) will require access to both you and your infant's medical records for a minimum of 8 weeks after delivery. Your study doctor will discuss these issues with you. New Findings Any significant new findings that develop during the course of research, which might change your decision to be in the study, will be provided to you. Benefits It is not possible to predict whether or not you will receive any personal medical benefit as a result of your participation in this study. This treatment decreases the symptoms associated with your disease, shrinks your tumor, and prolongs your survival; however, the likelihood of this benefit is unknown. No guarantee can be promised. Information obtained from this study may help others with cancer. Costs You will not be charged for the study drug BMS-247550. The laboratory testing (blood and urine tests), x-rays, ECGs, and scanning procedures done in this study are considered routine, standard testing for the treatment of your disease. You or your third party will be responsible for the costs of these standard procedures. Your health insurance company may or may not pay for these charges. During the study, some of the scanning procedures may be considered non-routine or non-standard. In these instances, the sponsor may provide coverage for these specific procedures. Treatments to help control side effects could result in added costs. Payment for Participation You will not be paid for participating in this study. Alternative Treatment You do not have to participate in this study to receive treatment for your condition. There are alternative treatments, such as Navelbine® or gemcitabine, available as a non-participant. The side effects of these may include low blood counts, vomiting, nausea, and diarrhea. Additional side effects may also be possible, so this, as well as the benefits of these two drugs, should be discussed with your study doctor. You may also decide on treatment of your symptoms only, with no further cancer therapy. Other investigational study plans with chemotherapy or alternative anti-cancer agents may be available for your disease- If you do not elect to continue in this study, your study doctor will discuss in detail with you the alternative treatments available for your disease and their possible benefits. Compensation for Injury Medical care will be made available to you to treat any physical injury you suffer as a direct result of the administration of the study medication or procedures, it will be necessary for you to cooperate in obtaining any proceeds from insurance or other third party coverage that may be available to you for such medical care. No money or other form of compensation (such as for lost wages or discomfort) will normally be offered to you for such injuries, however, you do not waive any legal rights as a research subject by signing this consent form. Your health insurance company may or may not pay for treatment of injuries as a result of your participation in this study. Voluntary Participation/Withdrawal Your participation in this study is entirely voluntary. It is up to you to decide whether to take part or not. Even if you do decide to take part, you are free to leave the study at any time without giving a reason. This will not affect your future medical care in any way at this site. Furthermore, your study doctor or the sponsor may withdraw you from the study without your consent if your cancer becomes worse, if side effects are too severe, or if you feel that this treatment is no longer in your best interest. Treatment may also be stopped if the sponsoring company (Bristol-Myers Squibb, BMS) decides to stop the study. Sponsoring Company The pharmaceutical company sponsoring this study is Bristol-Myers Squibb (including agents, contractors, or consultants). Your study doctor or hospital will be paid for including you in this study. Questions If you have any questions regarding the study, subject rights, or in case of study-related injuries, contact your study doctor. If you have any questions or concerns about the medication used in this study, you can contact study doctor Linda D. Bosserman, M.D. or a member of the research study staff at any time. The 24-hour telephone number is 909-865-9960. Please report any injury immediately to Linda D. Bosserman, M.D. or the research study staff. The 24-hour emergency telephone number is 909-865-9960. If you seek emergency care, or if hospitalization is required, inform the treating doctor that you are participating in a clinical study. |