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Clinical Trial Listing

001: FOR MORE INFORMATION ON ANY OF THESE TRIALS PLEASE CALL 504-842-4481 
Call 504-842-4481 to reach the main line for the Ochsner Cancer Institute Clinical Trials Department. Leave a message with a summary of your diagnosis and/or trial interests and we will call you back as soon as possible
 
2008.124.N - Rectal Cancer and the effects of Laparoscopic-Assisted vs Open Resection 
This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer.
 
2008.127.N - Stage 1 Non-Small Cell Lung Cancer and the Effects of Different Types of Surgery 

Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer. This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.


 
2010.011.N - Prostate Cancer and the effects of Radiation Therapy with or without Androgen-Deprivation Therapy 
This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
 
2010.040.N - NSABP B-43 - Ductal Carcinoma In Situ and the effects of Radiation Therapy with or without Trastuzumab 
This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy.
 
2010.084.N - Pancreas and the effects of Erlotinib and Chemoradiation 
This randomized phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery.
 
2010.084.N - Pancreatic Cancer and the Effects of Both Erlotinib and Chemoradiation as Adjuvant Treatment After Resection 

This randomized phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer

 

 

 
2010.096.N - Liver Cancer and the effects of Sorafenib Tosylate and Doxorubicin Hydrochloride 
Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
 
2010.154.N - Lung Cancer and the effects of Carboplatin and Paclitaxel with or without Bevacizumab and/or Cetuximab 
This randomized phase III trial is studying carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or recurrent non-small cell lung cancer.
 
2010.156.N - Colon Cancer and the effects of Celecoxib 
This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
 
2010.170.N - Lung Cancer (NSCLC) and the effects of Bevacizumab or Pemetrexed Disodium with Induction Therapy 
This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
 
2010.172.N - Small-Cell Lung Cancer Receiving and the Effects of Radiation Therapy Regimens 

This randomized phase III trial is comparing three different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.


 
2010.208.N - Prostate Cancer (with a Rising PSA After Radical Prostatectomy) and the effects of Short-Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed-Only Radiotherapy (SPPORT) 

This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

 


 
2011.053.N-Asymptomatic High-Risk Smoldering Multiple Myeloma and the Effects of Lenalidomide vs. Observation Only 

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma Charles Wendling MD 2011.053.N Open to new patients 3 This phase II/III trial is studying lenalidomide to see how well it works compared to observation in treating p

 
2011.054.N - Invasive Breast Cancer and the effects of Trastuzumab 
This randomized phase III clinical trial is studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer.
 
2011.103.B - Studying First-Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-World Setting (SIMPLICITY) 
The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
 
2011.113.N - High-Risk Stage III or Stage IV Melanoma and the effects of Ipilimumab or High-Dose Interferon Alfa-2b 
 This phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery.
 
2011.188.N - S1007- Invasive Breast Cancer and the effects of Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane 
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less Greg Bizette, M.D. 2011.188.N Open to new patients 3 This phase III clinical tr
 
2012.014.A - Follicular Lymphoma and the Effects of Combined Rituximab and Lenalidomide Treatment 

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.


 
2012.015.N - Oropharynx Cancer and the Effects of Radiotherapy Plus Cetuximab vs. Chemoradiotherapy (RTOG 1016) 

Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.


 
2012.021.N - Protocol for the Enrollment on the Official COG Registry 
The Children's Oncology Group (COG) has established a research network, known as the Childhood Cancer Research Network (CCRN), for collecting information about children & young adults with cancer and other conditions that are characterized by abnormal cell growth but are benign (not cancer) in order to help doctors and scientists better understand childhood cancer. The goal is to have clinical information about every child & young adult diagnosed with cancer and other conditions that are characterized by abnormal cell growth in the United States and Canada. This information can then be used by researchers to answer questions such as whether childhood cancer is increasing across the United States or Canada, and whether there is a higher risk of cancer among some groups compared to others. The information can also help researchers study the causes of childhood cancer.
 
2012.022.N - Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma 

 AOST06B1-A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens Rajasekharan Warrier, M.D. 2012.022.N Open to new patients Not Applicable The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma. DISEASE

 
2012.022.N - Study of Kidney Tumors in Young Patients 
This laboratory study is looking at kidney tumors in young patients.
 
2012.024.N - Collecting and Storing Biological Samples From Patients With Ewing Sarcoma 
This research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with Ewing sarcoma.
 
2012.026.N - Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia 
AALL08B1- Classification of Newly Diagnosed Acute Lymphoblastic Leukemia Rajasekharan Warrier, M.D. 2012.026.N Open to new patients Not Applicable This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. DISEASE CHARACTERISTICS:
 
2012.042.N - Study of Kidney Tumors in Young Patients 

This laboratory study is looking at kidney tumors in young patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help the study of cancer in the future.

 
2012.051.N - Nonmetastatic Extracranial Ewing Sarcoma and the Effects of Combination Chemotherapy 
This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma.
 
2012.086.N - Lymphoblastic Leukemia and the effects of Risk-Adapted Chemotherapy 
This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia.
 
2012.087.N - T-Cell ALL/Lymphoblastic Lymphoma Combination Chemotherapy 

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

 
2012.090.N - Endometrial Carcinoma and the Effects of Carboplatin and Paclitaxel 
This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage I, stage II, stage III, or stage IVA endometrial cancer.
 
2012.091.N - Ovarian Cancer and the Effects of Paclitaxel and Carboplatin 
This randomized phase III trial is studying giving paclitaxel together with carboplatin to see how well it works compared with giving paclitaxel together with ifosfamide in treating patients with newly diagnosed persistent or recurrent uterine or ovarian cancer.
 
2012.093.N - Esophageal Cancer and the Effects of Traztuxumab to treatment for HER2-Overexpressing Tmors 
This randomized phase III trial is studying how well giving radiation therapy, paclitaxel, and carboplatin together with or without trastuzumab works in treating patients with esophageal cancer.
 
2012.103.A - Arthralgia induced by AIs and the Effects of Subcutaneous Testosterone 

Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole. This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia caused by anastrozole or letrozole.


 
2012.115.N - Cervical Cancer and the Effects of Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel 
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer.
 
2012.117.N - Hepatocellular Cancer and the Effects of Chemoembolization With or Without Sorafenib 
This randomized phase III trial is studying chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery
 
2012.118.N - Rectal Cancer and The Effects of Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients Undergoing Surgery 

Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer. This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery

 

 
2012.120.B - Mesothelioma and the Effects of Pemetrexed Disodium vs. Observation After First Line Therapy 
This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.
 
2012.128.N - de Novo AML With or Without mutations and the Effects of Bortezomib and Sorafenib Tosylate 
This randomized phase II/III trial is studying how well giving bortezomib and sorafenib tosylate together works in treating patients with newly diagnosed acute myeloid leukemia with or without mutations. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
 
2012.129.N - B-precursor ALL and the Effectts of Clofarabine in the Very High Risk Stratum 
This randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia.
 
2012.134.N - Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma 
This laboratory study is looking at biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma
 
2012.160.A - Chemo-Inducted Nausea and Vomiting and the Effects of IV Fosaprepitant Dimeglumine 

This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).

 
2012.168.N - Collecting and Storing Tissue for Young Patients With Cancer 
This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer.
 
2012.169.N - AML and the Effects of Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients 
This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
 
2012.170.N - Pediatric ALL and Compliance With Mercaptopurine Treatment 
This randomized clinical trial is assessing compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission.
 
2012.171.N - Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma 

The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of cancer.


 
2012.186.N - AML or Stem Cell Transplant Patients and the Effects of Levofloxacin in Preventing Infection 
This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia
 
2012.187.N - B-cell NHL, B-AL, or Mature B-Cell Leukemia and the Effects of Combination Chemotherapy With or Without Rituximab 

This randomized phase II/III trial studies how well giving combination chemotherapy with or without rituximab works in treating younger patients with stage III or stage IV non-Hodgkin lymphoma or B-cell acute leukemia.  

 
2012.187.N - Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma 
This research study is collecting and storing tissue samples from patients with rare or cutaneous non-Hodgkin lymphoma
 
2012.209.A - Metastatic HER2-, Hormone + Breast Cancer and the Effects of BKM120 With Fulvestrant (BELLE3) 

This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.


 
2012.214.N - Hepatoblastoma and the Effects of Combination Chemotherapy 
This phase III trial is studying the side effects of giving doxorubicin hydrochloride together with combination chemotherapy and to compare different chemotherapy regimens to see how well they work in treating young patients with newly diagnosed liver cancer.
 
2013.025.N-AML and the effects of Clofarabine as Induction therapy vs. Standard of Care 
This randomized phase III trial is studying clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia.
 
2013.026.B - Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial 

Patients submit bone marrow and/or blood samples. The samples are studied to determine patients' eligibility for ECOG leukemia treatment clinical trials. Samples may be stored for future correlative studies related to ECOG treatment clinical trials.

 

 
2013.031.B - Mantle Cell Lymphoma and the Effects of Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide 
This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.
 
2013.034.C - Follicular Lymphoma and the Effects of Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab +/- Lenalidomide 
This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.
 
2013.042.C - Endometrial and Cervical Cancer and the Effect of Standard Versus Intensity-Modulated Pelvic Radiation Therapy 
This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
 
2013.054.A - Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors 
The purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory.
 
2013.070.A - Melanoma and the Effect of Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b 

This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma


 
2013.091.A - Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy 
This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.
 
2013.103.N - Early Stage Breast Cancer and the Effects of Standard vs. Comprehensive Radiation after Neoadjuvant Chemotherapy and Surgery 

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer


 
2013.115.N - Breast Cancer and the effects of primary tumor surgery on Stage IV disease 
This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
 
2013.146.B - Carcinoid Tumors and the Effects of Pazopanib vs. Placebo 

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with progressive carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


 
2013.147.B - Pancreatic Neuroendocrine tumor and the effects of Temozolomide With or Without Capecitabine 

This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.


 
2013.162.N - Prostate Cancer and the Effects of Androgen-Deprivation Therapy and Radiation Therapy 

Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.


 
2013.165.N - High-Risk Prostate Cancer and the Effects of Hormone Therapy, Radiation Therapy, and TAK-700 

Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.  This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.


 
2013.166.N - Stage III-IV Squamous Cell Head and Neck Cancer and the Effects of Radiation Therapy With Cisplatin, Docetaxel, or Cetuximab After Surgery 

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered With Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck Troy Scroggins, MD 2013.166.N Open to new patients 3 This randomized phase II/III trial studie

 
2013.167.A - Small cell Lung Cancer (Extensive) and the Effects of Radiation Therapy 

Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) Minnie Elnaggar, MD 2013.167.A Open to new patients 2 This randomized phase II trial is compa

 
2013.175.B - Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer and the Effects of Combination Chemo 

 Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells. This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer

 

 
2013.175.B - Advanced/Metastatic Esophageal, Gastric, or GEJ Cancer and the Effects of Treatment Based on ERCC1 (S1201) 
Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells.  This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.
 
2013.178.A - Stage I-III Breast Cancer and Detecting Genetic Predictors for Musculoskeletal Symptoms Cause by Anastrozole 
This pilot clinical trial studies anastrozole in treating aromatase inhibitor musculoskeletal symptoms in female patients with stage I-III breast cancer. Anastrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
 
2013.200.A - Ovarian Cancer and the Effects of Screening Using Gynecologic Fluids and Mucus 

Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this mucus is collected along with any cells, and preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile showing of the status of the cells in the female reproductive system. We have examined this fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian cancer when compared against healthy controls. These markers will be initially refined using the comparison of ovarian cancer patients against those with benign adnexal masses that entered the clinic during the same time period.

In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.


 
2013.208.C - Colorectal Cancer and the Effects of FOLFOX6 plus SIR-Spheres Microspheres (STX0112) 

This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.


 
2013.221.B - Diffuse Large B Cell Lymphoma and the Efffects of R2CHOP vs. RCHOP 

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide works in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.


 
2013.247.N - Hormone-Positive Breast Cancer and the Effects of Everolimus with Endocrine Therapy 

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.


 
2013.261.N - Node Positive Breast Cancer and the Effects of Axillary Lymph Node Dissection Vs. Axillary Radiation 

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy alone in treating patients with node-positive breast cancer previously treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.


 
2013.274.C - Esophageal Cancer and the effects of PET Scan-Directed Combined Modality Therapy 

PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment.

This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.

 

 
2014.008.N - Metastatic Pancreatic Neuroendocrine Tumors to the Liver and the Effects of Adjuvant Everolimus (E2212) 

This randomized phase II trial studies how well everolimus works in treating patients with pancreatic neuroendocrine tumors metastatic to the liver previously treated with surgery. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus after surgery may kill any tumors cells that remain.


 
2014.009.B - Non-hodgkin's Lymphoma and the Effect of GA101 vs. Rituximab 

Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response.

Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma.

GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death induction compared to Rituximab. It is possible that GA101 may have greater efficacy than rituximab.

 

 
2014.013.N - Renal Cancer and the Effects of Everolimus after Surgery 

Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.


 
2014.055.C - Collecting and Banking Pediatric Research Specimens for Rare Pediatric Tumors 

This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.


 
2014.059.N - Non-Metastatic Desmoplastic Medulloblastoma and the Effects of Combination Chemo for Younger Patients 

This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.


 
2014.079.N - Hormone Receptor, HER2 Positive Breast Cancer and the Effects of Neoadjuvant Therapy with or without Estrogen Deprivation 
This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive, operable or locally advanced breast cancer.
 
2014.086.A - Locally Recurrent/Metastatic Breast Cancer and the Effects of Eribulin Compared to Standard Weekly Paclitaxel (BOLD 303) 

This is a two arm Phase III trial in first- and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression will be followed with repeat imaging studies every 12 weeks. All subjects will be followed until death, withdrawal of consent, or study termination.


 
2014.163.A - Gastric and Gastro-Esophageal Junction Cancer and the Effects of BBI608 Plus Weekly Paclitaxel vs. Paclitaxel Alone 

The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.


 

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