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Clinical Trials

Clinical Trials
Today, we have better and more effective cancer drugs and therapies because of research. As a result of these newer treatments, survival rates have increased, quality of life has been improved and treatment side effects are fewer for thousands of people with cancer. Many of these drugs and therapies would not be available today if it were not for cancer research programs and cancer patients willing to participate in clinical trials. Some people feel that participating in a clinical trial gives them an opportunity to help other people with cancer through the knowledge gained from the study.


What is a clinical trial?
A clinical trial is a research study designed to answer one or more questions about how a certain drug, treatment or medical device affects a disease such as cancer. There are potential benefits to participating in a clinical trial, as well as potential risks. These benefits and risks are different for each clinical trial. You should discuss them with your own doctor, as well as with the clinical trial's research team.
 
Is participating in a clinical trial right for me?
The treatment you receive during a clinical trial may help you. Clinical trial participants receive either the most effective known treatment available or the new drug or treatment being considered. Newer therapies may lead to better results. On the other hand, they may not be any better, or even as good as, the standard treatment already available.
 
How do we enroll people in clinical trials?

Clinical trials usually evaluate very specific new treatments for very specific conditions. Therefore, they have very strict criteria about who is and who is not a candidate for each study. To ensure you have the broadest possible range of treatment options available, our research nurse will review your case during the diagnosis stage to see if you may match any of the criteria for the clinical trials in which Beaver Medical Group is participating.

If you are eligible for a current study, a research nurse will provide the details of the study to your oncologist, who will then ask you if you would be interested in learning more about participating in the clinical trial. Participating in a clinical trial will require some extra time on your part. The research team will want to monitor you closely during the trial and collect follow-up information. This care is in addition to the care you will continue to receive from your oncologist and medical team.

Contact the Clinical Research Coordinator at Beaver Medical Group, Oncology at (909) 425-3372 for information.


If you are interested in a clinical trial, here are the steps you will need to take to enroll in the study:


1. Receive a 15- to 20-page form on the study from your oncologist to take home and review. Informed consent is critical for a good clinical trial, so even if you are sure that you would like to do the study, you must take the information home and review it before you can sign up. The form, which is called an informed consent form, will include answers to the following questions:

a. What is the purpose of the clinical trial?
b. How long will the trial last?
c. What is required of you to participate in this study?
d. What treatments or drugs will you receive during the trial?
e. What treatments, tests and/or procedures will be required during the study? How many and how often?
f. Which treatments, tests, medications and/or procedures will be paid for?
g. What are the risks and benefits of participating in the study?
h. What treatment would be recommended for you if you do not participate in the trial?


2. Meet with the research nurse who will review the contents of the form with you again and show you the areas on the form  that you need to sign.


3. After the research nurse registers you with the study, you will be randomly selected for either a "control" group that receives the standard treatment or a "trial" group that receives the new treatment. Cancer patients are never given no treatment, like in the sugar-pill "placebo" groups in old science text books. Instead, the tested treatment is compared to current treatments. In some instances you will not know which group you are in, and neither will your doctors or the researchers, until the study is over.  In other instances you along with your doctors and the researchers will know exactly what you are receiving.


Participation in clinical trials is always voluntary.
You will never be enrolled in a clinical trial without your permission, and you can change your mind about participating in the clinical trial at any time after signing the informed consent forms. To stop participation in a study, simply talk to your research team.  Results can vary for individuals involved in a clinical trial.  Participants enrolled in clinical trials must have clear and realistic expectations based on their individual health status and diagnosis.

Current Trials – Oncology: Open to Enrollment

  • A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) (Shingles) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)  (Solid Tumor Arm Closed to Enrollment)
  • A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (HER2+ Metastatic Breast Cancer Patients
  • Symptom Burden and Quality of Life Outcomes in Advanced NSCLC Patients Treated in the Community Setting (Patients will complete questionnaires before each chemotherapy treatment and at each scheduled follow up for a year)                                            
  • Randomized Open-Label Study of INCB047986 in Subjects With Primary Myelodysplastic Syndrome (MDS) (Transfusion dependent, unlikely to respond to Erythropoiesis-Stimulating agents; ESA's)
  • Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia
  • Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer (Postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received nor prior therapy for advanced disease). Visit www.lee011.com  for more information on this trial.

 

Current Trials - Oncology CLOSED TO ENROLLMENT:

  • A multicenter, open-label, phase 2 study to evaluate the safety and efficacy of NKTR-102 (PEG-Irinotecan) when given on a Q14 or a Q21 day schedule in patients with metastatic or locally advanced platinum-resistant ovarian cancer -Enrollment is limited to platinum refractory patients. Platinum-refractory ovarian cancer defined as: Clinical or radiographic progression on 1st or 2nd line platinum-based therapy within 3 weeks of the date of the last platinum treatment; patients must have received a minimum of 2 cycles of platinum treatment on the most recent line of platinum-based therapy. Patients with progression based upon CA-125 assessments only are not eligible.
  • A randomized phase II study of Human Anti-PDGFRa Monoclonal Antibody (IMC-3G3) with Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Previously Untreated Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
  • A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
  • A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
  • An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin administered in combination with Rituximab compared to Defined Investigators Choice Therapy in Subjects With Relapsed or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma who are not Candidates for Intensive High-Dose Chemotherapy
  • A Phase 3, Randomized, Double-Blind, Phase 2, Efficacy and Safety Study of MDV3100 VS Bicalutamide in Castrate men with Metastatic Prostate Cancer
  • An Open Label Assessment of an Alternative Dosing Strategy of Ruxolitinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis and Post-Essential Thrombocythemia-Myelofibrosis
  • A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer
  •  A Phase III Randomized, Multicenter, Two-Arm, Open-Label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2 Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
  • Phase 2 Study of HM10460A or Pegfilgrastim (Neulasta) Use for the Management of Neutropenia in Breast Cancer Patients (Newly Diagnosed, eligible for T-C chemotherapy)