Cancer Clinical Trials

Orange Regional Medical Center
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Cancer Clinical Trials & Research Program

Orange Regional Medical Center has an active Clinical Oncology Trials program in place. We are a main member of Southwest Oncology Group Studies and also participate in American College of Surgeons Oncology Group (ACOSOG), Radiation Therapy Oncology Group (RTOG) and other Inter-group studies through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Clinical trials provide patients at all stages of cancer with leading edge medical treatment and the highest level of care. In most cases, the new treatment has already shown promise of being an improvement over the standard treatment. Many clinical trials are tests to see how much better a new treatment works than the current one.

Orange Regional Medical Center currently offers several clinical trial protocols for the following types of cancer:

Breast Cancer

NRG-BR003: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

The purpose of this study is to compare the good and bad effects of the chemotherapy drug, carboplatin, given with the usual chemotherapy drugs after surgery, compared to the usual chemotherapy drugs given without carboplatin. The addition of carboplatin to the usual chemotherapy could prevent your cancer from returning, but it could also cause side effects. This study will allow the researchers to know whether giving carboplatin with the usual chemotherapy is better, the same, or worse than giving the usual chemotherapy. If giving carboplatin with the usual chemotherapy drugs is better, there should be a higher chance that your breast cancer will not return. Carboplatin is FDA-approved for the treatment of cancer and is used for the treatment of breast cancer that has spread, but it has not yet been proven useful in earlier stages of breast cancer.

NRG-BR003 Clinical Trial


S1418: A Randomized Phase III Trial to Evaluate the Efficacy and Safety of Pembrolizumab as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse than the usual approach. There will be about 1,000 people taking part in this study

S1418 Clinical Trial


A011502: A randomized phase III double blinded placebo-controlled trial of aspirin as adjuvant therapy for node-positive, HER2 negative breast cancer: the ABC trial

The purpose of this study is to compare any good and bad effects of using aspirin after someone has completed the usual chemotherapy, surgery and/or radiation therapy for breast cancer. Some studies have suggested that aspirin may lower the risk of breast cancer coming back, but others have not, so we do not know if aspirin will help decrease breast cancer recurrence. This study will evaluate whether patients taking aspirin once per day will have a lower rate of cancer recurrence than patients taking a placebo. A placebo is a tablet that looks like the study drug (aspirin), but contains no medication. Aspirin is approved by the Federal Drug Administration (FDA) of the United States, but is not approved for the purpose of lowering the risk of breast cancer coming back or improving survival.

A011502 Clinical Trial
A011502 Patient Information Sheet


A011203: A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer

You are being asked to participate in this study because you are a postmenopausal woman with estrogen receptor positive and HER2 negative breast cancer that no longer responds to aromatase inhibitors (anti-estrogen therapy) and has spread in the breast, or to other parts of your body. For patients who receive the usual approach for this cancer, tamoxifen, about 20 out of 100 patients are alive without cancer progression after 1 year of treatment. Estrogen receptor positive means that your cancer is potentially sensitive to anti-estrogen therapy. HER2 negative means that you do not have too many HER2 cells, which can cause breast cancer to grow faster. Postmenopausal women with your type of breast cancer are usually treated with hormonal therapy.

A011203 Clinical Trial


S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating The Use Of Adjuvant Endocrine Therapy +/- 1 Year Of Everolimus In Patients With High-Risk Hormone Receptor-Positive & HER2/NEU Negative Breast Cancer

The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.  The current standard treatment after chemotherapy is hormone treatment alone.  Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney or breast cancer. It is considered investigational for non-metastatic breast cancer patients.  In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.

S1207 Clinical Trial


E1Z11: A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

This research is being done to find out what effects, good and/or bad, that anastrozole has on you and whether your genes can help explain how 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.

E1Z11 Clinical Trial

Gastrointestinal (colon, rectum, pancreas)

S1505: A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

The purpose of this study is to compare the effects of two different combinations of FDA-approved chemotherapy drugs. These two combinations are called mFOLFIRINOX (oxaliplatin, irinotecan, and fluorouracil) and gemcitabine plus nab-paclitaxel. These chemotherapy drugs will be given before and after surgery. The addition of these chemotherapy drugs before surgery is a new approach that is being tested in this study. This new approach could prevent your cancer from returning, but it could also cause side-effects. This study will allow the researchers to know if it is a good idea to treat pancreatic cancer with chemotherapy drugs before surgery, and if so, to see which of the two drug combinations is better. To be better, the study approach should increase the number of people alive at 2 years from about 40% with the usual approach to about 58% with the newer approach.

S1505 Clinical Trial


S1316: Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

You are being asked to take part in this study because you have a malignant bowel obstruction (MBO) and your doctor is not sure if surgery or non-surgical treatment will be better for your condition. MBO means you have a blockage of the bowels due to cancer or its treatment, and you likely still have cancer inside of you. People who have MBO and choose not to participate in a study are treated with either abdominal surgery or non-surgical treatment. Both of these options are commonly used, considered standard of care, and will be described to you by your physician.

S1316 Clinical Trial


S1513: Randomized Phase II Study of 2nd Line FOLFIRI Versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer

The purpose of this study is to compare the effects of two different combinations of FDA-approved chemotherapy drugs. These two combinations are called mFOLFIRINOX (oxaliplatin, irinotecan, and fluorouracil) and gemcitabine plus nab-paclitaxel. These chemotherapy drugs will be given before and after surgery. The addition of these chemotherapy drugs before surgery is a new approach that is being tested in this study. This new approach could prevent your cancer from returning, but it could also cause side-effects. This study will allow the researchers to know if it is a good idea to treat pancreatic cancer with chemotherapy drugs before surgery, and if so, to see which of the two drug combinations is better. To be better, the study approach should increase the number of people alive at 2 years from about 40% with the usual approach to about 58% with the newer approach.

S1513 Clinical Trial


N1048: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation vs. Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer.

N1048 Clinical Trial

Genitourinary (bladder, kidney, prostate)

S1605: Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

The purpose of this study is to test the good and bad effects of the investigational drug atezolizumab in stopping non-muscle invasive bladder cancer from coming back and progressing to muscle invasive bladder cancer. Atezolizumab is not approved by the FDA for treatment of this type of cancer. Atezolizumab is a type of immunotherapy (a drug that helps your body to fight a specific part of each cancer cell).

S1605 Clinical Trial


S1216: 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

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 your body, TAK-700 is expected to control the growth of your prostate cancer.

S1216 Clinical Trial


E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy

The purpose of this study is to determine whether taking an oral drug known as pazopanib (Votrient®) will reduce the risk of the cancer recurring in the future.

Pazopanib is approved by the FDA for patients who have metastatic renal cell carcinoma. However, it has not been tested in patients who have had all visible areas of their cancer removed surgically, and is considered experimental in this situation. We don’t know if pazopanib will be helpful to patients in this scenario.  There is currently no standard of care for patients in this situation but careful observation without treatment is considered reasonable.

E2810 Clinical Trial

 

 

Lung Cancer

S1403: A Randomized Phase II/III Trial of Afatinib + Cetuximab vs. Afatinib Alone in Treatment Naïve Patients with Advanced EGFR Mutation Positive Non-Small Cell Lung Cancer

The purpose of this study is to compare any good and bad effects of using afatinib along with cetuximab to using afatinib alone. The addition of cetuximab to the usual afatinib could shrink your 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. Afatinib is already FDA-approved for use in advanced non-small lung cancer and cetuximab is FDA-approved for treating other types of cancer, but using them together is considered investigational.

S1403 Clinical Trial


S1400: A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

The purpose of this study screening step is to test specific genes and proteins in your tumor sample.  Based on the test results, you will be assigned to one of the treatment studies. We do not know how accurate this screening will be in matching your tumor type to a drug to treat your tumor.  You may choose to not take part in the treatment study assigned to you.  Before you decide to get treatment on the study, you will be given information about the treatment and you will be asked if you wish to take part in treatment on this research study.

S1400 Clinical Trial
S1400 Q&A For Patients


S1507: A Phase II Trial of Trametinib with Docetaxel in Patients with KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies

The purpose of this study is to test any good and bad effects of the combination of trametinib and docetaxel in patients with KRAS mutant lung cancer. Docetaxel is FDA-approved to treat your type of cancer but trametinib is not.  However, trametinib is FDA-approved to treat other cancers.  The combination of the two drugs is considered investigational.  These drugs could shrink your cancer by about one-third in size but they could also cause side effects. Researchers hope to learn if this combination will shrink cancer in at least 37% of patients.

Lymphoma

S1001: A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)

Limited (or early) Stage Diffuse Large B-cell Lymphoma is curable in many people, but some still relapse, and some develop side-effects after this treatment. This study uses a radiologic test called PET/CT scan to determine treatment after initial doses of a standard chemotherapy called “R-CHOP” (the drugs doxorubicin, cyclophosphamide, vincristine, prednisone and rituximab). Although all of the agents used in this study are FDA approved, the purpose of the study is to give more intensive treatment to patients whose PET/CT scan shows that they are at a greater chance of still having active lymphoma, and to give less intensive treatment to patients whose PET/CT scan shows that they have a smaller chance of still having active lymphoma. In this way, we hope to improve the cure rate for all patients while decreasing the side effects of the treatment.

S1001 Clinical Trial

Melanoma

EA6141: Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

The purpose of this research study is to compare any good and bad effects of giving ipilimumab, nivolumab, and GM-CSF (Sargramostim) at the same time compared to just ipilimumab and nivolumab together. We would also like to find out what effects, good and bad, that this combination of drugs may have on your cancer. This study will involve the addition of the FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy in the hopes that it might further improve the good effects of the immunotherapy component of the treatment sequence. The combination of ipilimumab and nivolumab has been shown in recent studies to produce superior antitumor effects but also more side effects than ipilimumab alone. This combination has received FDA approval for patients with BRAF V600 wild-type unresectable or metastatic melanoma. This combination is under review for FDA approval for patients with BRAF V600 mutant melanoma and is therefore still considered to be experimental for these patients. GM-CSF is a protein that your body normally produces to signal to your body to make white blood cells. White blood cells are very important in the body’s defense system as they help identify and destroy foreign invaders, such as bacteria, viruses, and cells that don’t belong, such as cancer cells. Injections of GM-CSF increase your body’s production of white blood cells and also help enhance the function of the white blood cells. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drugs should improve how long you are able to live with your cancer compared to the usual approach.

EA6141 Clinical Trial


EA6134: A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma

Given that there are multiple treatment approaches now available for patients with advanced melanoma that contains a mutation in the BRAF protein, patients have a choice which treatment to receive first and therefore the potential sequence of treatments. Currently there is no data on which treatment approach (initial treatment or sequence of treatments) yields the best outcome for a given patient or group of patients. The purpose of this research study is to compare the good and bad effects of the sequence of immunotherapy followed by BRAF inhibitor therapy if and when the disease becomes resistant, to the sequence of BRAF inhibitor therapy followed by immunotherapy if and when the disease becomes resistant. The BRAF inhibitor component will include the combination of two drugs dabrafenib and trametinib that each have been approved by the FDA for the treatment of this patient population and have also been approved for use in combination due to superior effects relative to the single agent treatments. In addition, the study will involve the addition of the FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy in the hopes that it might further improve the good effects of the immunotherapy component of the treatment sequence. The combination of ipilimumab and nivolumab has been shown in recent studies to produce superior antitumor effects but also more side effects than ipilimumab alone. This combination has yet to receive FDA approval and is therefore still considered to be experimental. This research study will allow the investigators to determine which sequence of treatment has the best outcome for patients. To be better, one sequence should significantly improve the number of patients alive at 2 and 3 years from start of treatment relative to the alternative sequence.

EA6134 Clinical Trial
EA6134 Pocket Guide


S1404: A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma

The purpose of this study is to compare the effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) to the usual treatment of either interferon alfa-2b or ipilimumab. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse than usual treatment. In this study, you will get either MK-3475 or a choice of either interferon alfa-2b or ipilimumab.

S1404 Clinical Trial

Multiple Myeloma

S1211: A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)

One of the standard treatments for High Risk Multiple Myeloma is the combination of bortezomib, lenalidomide and dexamethasone (RVD).  Elotuzumab is an experimental cancer drug.  It is currently being tested in cancer patients.  There are laboratory results that suggest that RVD might work better if elotuzumab is added.

S1211 Clinical Trial


E3A06: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma

The purpose of this study is to find out what effects (good and bad) the use of the drug lenalidomide has on you and your multiple myeloma, and to compare this with patients that receive no therapy. Currently, the accepted treatment for asymptomatic myeloma is to receive no therapy. However, not all patients with asymptomatic (smoldering) myeloma have the same outcome. There are 3 groups of patients as identified by the Mayo clinic group that have different predicted outcomes. Because the 3 groups can have very long delays between the identification of smoldering myeloma and the requirement for treatment, not all patients are eligible for this study. Only patients with ”high-risk” smoldering myeloma are considered eligible for this study as these are all patients whose risk of developing myeloma that requires therapy is the highest.

E3A06 Clinical Trial


E1A11: A Randomized Phase III Trial of Bortezomib, Lenalidomide & Dexamethasone vs. Carfilzomib, Lenalidomide, Dexamethasone Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma

The treatment of myeloma has significantly changed as a result of several drugs being introduced for its treatment such as bortezomib, carfilzomib and lenalidomide. All these drugs used with dexamethasone or in combinations that contain more than one of these drugs allow greater control of the disease process. However, we still do not fully understand the best way to combine these drugs and how long the treatment process needs to be continued in order to provide the maximum benefit to the patients. The treatment combinations that are being compared in this study are both effective, but they have different side effects, which can impact whether patients tolerate the treatment for a prolonged time.

This study has two parts, the first part is related to the initial treatment of your myeloma (also called induction) and a second part is related to continued long term control of the myeloma (also called maintenance). The purpose of the first part of the study is to compare the effects, good and/or bad, of a combination of carfilzomib, lenalidomide and dexamethasone with another combination of bortezomib, lenalidomide and dexamethasone, on you and your cancer to find out which is better. In this study, you will get either the combination that contains carfilzomib or that containing bortezomib. You will not get both. Following the initial treatment of your myeloma (induction), the second part of the study will examine if it is better to continue lenalidomide until the myeloma comes back or limit it for a defined period of 2 years. In this study, your lenalidomide will be either stopped after 2 years or you will stay on it until the myeloma relapses.

E1A11 Clinical Trial

For more information on these protocols or any other research, please contact your physician or our clinical research coordinator:

Jessica Gerlach
Manager of Clinical Trials & Community Outreach
845-333-1133
jgerlach@ghvhs.org


Should you have any questions about your stay at Orange Regional Medical Center or about planning to visit a family or friend who is a patient, do not hesitate to contact us at 845-333-1000.