Clinical Trials Currently Ongoing at White Plains Hospital
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy (B-43)
This study is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin) to breast radiation therapy. Radiation therapy is the standard treatment for patients with DCIS. This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-postivie DCIS.
A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer (B-47)
The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning. A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer. Another goal of this study is to find out how the drugs used in this study affect menstrual cycles and if these changes in menstrual cycles have any effect on breast cancer.
A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (S1007)
The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not. This study is being done in patients with lower Recurrence Scores (25 or less). Currently most women who have hormone receptor positive and HER2 negative breast cancer are treated with endocrine therapy (treatment that works with hormones). Many women also receive chemotherapy. No one really knows which patients with lower Recurrence Scores need to get chemotherapy. If the results of the study show that the benefit for getting chemotherapy is dependent on the Recurrence Score, the study may be able to identify a Recurrence Score level where chemotherapy should be considered (and a recurrence score level where chemotherapy may not be needed).
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer (E2108)
The standard treatment for metastatic breast cancer is the use of chemotherapy, anti-hormone pills, or other medication. When the cancer is no longer only in the breast and has spread to other areas of the body, surgery and/or radiation for the tumor in the breast cannot control the other areas of the cancer and are only used if the breast tumor is causing skin breakdown or pain. The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in the breast to the standard approach of continued treatment with the medication which is working to control the tumor. In this study, patients will get either surgery plus radiation for their breast, or continue with the best medical treatment advised by their doctor.
A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) (E1Z11)
The purpose of this study is to find out what effects, good and/or bad, anastrozole has on you, and whether your genes can help explain how the study drug, anastrozole, affects you. Specifically, many women who take anastrozole or one of the other aromatase inhibitors (letrozole or exemestane) during treatment for breast cancer report muscle and joint aches; however, the reasons that lead to these symptoms are not known. These symptoms have been designated “aromatase inhibitor-associated musculoskeletal syndrome” (or AIMSS). Small studies have suggested that a person’s genetic information may help us to develop a way to predict who will develop side effects and how best to treat them, and we hope to collect information in this study to look at this more closely. In addition, we hope to look at how the side effects from hormone therapy influence quality of life and a patient’s willingness to continue hormonal treatment. Women who are prescribed the aromatase inhibitor anastrozole as treatment for breast cancer may join this study.
A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor (AI)-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer (S1202)
The purpose of this study is to assess the effects, good and/or bad, of the medication duloxetine compared to placebo (contains no drug) on your joint pain that is associated with taking aromatase inhibitors. Duloxetine is a drug usually prescribed to treat depression or anxiety, pain caused by nerve damage or fibromyalgia (a painful muscle/bone/nerve disorder) and a muscle and bone pain from a type of arthritis. Researchers on this study want to see if the pain relieving effects of the drug work for your type of pain.
A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer (E2112)
The purpose of this study is find out what effects, both good and bad, an experimental drug called entinostat has on you and your cancer, when given together with the standard hormonal drug treatment, exemestane. Exemestane is an aromatase inhibitor which is used in breast cancer patients to inhibit (slow down) the growth of the breast cancer. In this study, patients will take exemestane, and either entinostat or an inactive substance (placebo). Entinostat is investigational and has not been approved by the Food and Drug Administration (FDA) for use in this cancer. If the patient is male, he will also receive Goserelin, a luteinizing hormone releasing hormone (LHRH) agonist that is used to suppress the production of testosterone and estrogen.
EVEREST: Everolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study (S0931)
The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment after surgery is careful monitoring with no immediate treatment. Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein named “mTOR.” Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery. In this study, patients will get either everolimus or placebo (a pill with no medication).
Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel, and Bevacizumab for Advanced Non-Squamous NSCLC (E5508)
The purpose of this study is to find out the best maintenance therapy for patients with advanced stage non-small cell lung cancer. Maintenance therapy is usually given after 4 cycles of standard chemotherapy (1 cycle = 21 days) to keep the disease under control for a longer duration. This study will compare the effects, good and/or bad, of bevacizumab, pemetrexed or the combination of the two agents when given as maintenance therapy.
A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination TL-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment (TLH-206)
The purpose of this study is to see if the investigational combination of drugs called TL-118 (the investigational drugs) given alongside Gemcitabine is effective in treatment of metastatic pancreatic cancer patients, and if people can tolerate taking it without it making them too sick. Investigational (experimental) drugs are drugs that are being tested in people but have not been approved by the U.S. Food and Drug Administration (FDA) for treatment of the studied disease.
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma (E3A06)
This research study is being done because there is no current therapy proven to benefit patients with high-risk (abnormalities in your blood or bone marrow) asymptomatic myeloma, a type of blood cell cancer that has not yet damages body tissue and organs to the point where symptoms are noticeable. These patients are not treated unless their disease progressed to symptomatic myeloma. The purpose of this study is to find out what effects (good and bad) the use of the drug lenalidomide has on patients and their multiple myeloma, and to compare this with patients that receive no therapy. Currently, the accepted treatment for asymptomatic myeloma is to receive no therapy.
A Randomized Phase II Trial of Ipilimumab with or Without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma (E3612)
The purpose of this research study is to compare the good and bad effects of using the study drug called ipilimumab either alone or in combination with the study drug called bevacizumab. This regimen could help improve how long patients are able to live with their cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach used to treat advanced melanoma. Ipilimumab is approved by the FDA at a dose of 3 mg/kg for a total of 4 doses given 3 weeks apart for metastatic melanoma that is not able to be surgically removed. Bevacizumab is not approved by the FDA to treat melanoma, and is an experimental treatment.
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer (S1216)
The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.TAK-700 is a pill that works by reducing the levels of testosterone and other male hormones that help your prostate cancer grow. TAK-700 acts on the adrenal glands and inside the prostate tumors and slows the amount of male hormones being produced. By lowering the amount of male hormones in the body, TAK-700 is expected to control the growth of prostate cancer.
Dietary Education and Livestrong® Exercise Program Study (DEALS-EPS)
The purpose of this research is to study how nutrition education and exercise affect newly diagnosed cancer patients. The researchers are also testing to see if starting an exercise immediately upon starting cancer treatment is better or worse than starting an exercise program one year later.
This research is being conducted because physician researchers think that nutritional intervention and exercise may improve outcomes and well-being of cancer patients. This is a randomized study which means participants will be randomly assigned to an arm of the study. Patients on Arm A will receive nutrition education and participate in the Livestrong® at the YMCA program within 6 months of starting cancer treatment. Patients on Arm B will receive nutrition education immediately but will wait one year to start the Livestrong® at the YMCA program.
A Randomized Placebo Control Trial for Pain Management in Cancer Patients Using Best Supportive Care for Pain Management With or Without Rocktape
The purpose of this study is to see if Rocktape can be used in cancer patients as a possible treatment for pain management. The physician researchers also want to see if Rocktape will help decrease pain and disability from lymphedema. Lymphedema is swelling caused by reduced blood and lymph fluid circulation. This is a blinded clinical trial which means participants will not know if they are receiving Rocktape or a different type of tape (placebo tape).
Pilot Evaluation of Tommie Copper Material and Its Impact on Pain Control
The purpose of this study is to see if copper-infused Tommie Copper clothing can be used for patients as a possible treatment for pain management. This is a blinded clinical trial which means neither the participant nor the doctor will know if they are receiving the copper-infused clothing or an identical clothing item produced without the copper.
Screening / Early Detection:
Lung Cancer Screening Program (IELCAPS)
This study will involve getting an annual CT examination. A CT of the chest is a test that uses special x-ray equipment to collect images from different angles around the body and then uses computer processing of the images to show a cross-section of body tissues and organs. Participants might qualify for this study if they are between the ages of 50 and 75, are a current or former smoker with at least a 20 pack-year history (the equivalent of smoking one pack a day for 20 years), and have no symptoms suspect of lung disease such as chronic cough. If participants are former smokers, they must have quit within the past 20 years.
This research is being conducted because physician researchers think it is possible that annual CT screening will enhance the possibility of early detection of lung cancer and that for those in whom lung cancer is diagnosed earlier this would lead to a higher cure rate.
Pancreatic Cancer Early Detection Program (PCEDP)
The purpose of this research is to study how well magnetic resonance imaging (MRI) and endoscopic ultrasound (EUS) screening of the pancreas can detect early pancreatic cancer for people who are at high risk of developing this cancer. An EUS is a procedure that allows a doctor to obtain images and information about the digestive tract and the surrounding tissue and organs. Ultrasound testing uses sound waves to make a picture of internal organs. Anesthesia is given prior to this procedure. A doctor will insert a small ultrasound device on the end of a tube into the mouth and use that device to take pictures of the inside of the body. Participants will undergo a baseline testing of an EUS followed by an MRI 6 months later. They will then be tested every six months if over age 65 or every 12 months if under age 65 and testing will alternate between and MRI and EUS.