Clinical trials are research studies that evaluate new medical approaches and increase scientific understanding of a wide variety of diseases.
At Duke, we believe that this research is key to improving health care throughout the world. Our goal is to quickly translate research findings into clinical care that benefits all patients.
Understanding Clinical Trials: A participants' guide (DukeHealth.org)
Clinical Trials at Duke Raleigh Hospital
For more information about any of the listed trials, please contact the clinical trials nurse Cindy Downing at 919-954-3085.
Breast
CALGB 40101: Phase III study of Cyclophosphamide and Doxorubicin (x 4) versus Paclitaxel (x 4) in women with 0-3 positive axillary lymph nodes (Reference #9899)
CTSU ECOG TAILORx: Trial randomizing women with T1-2, N0, ER/PR+, HER-2 negative breast cancer who undergo Oncotype DX scoring to hormonal rx or chemotherapy if an intermediate score is found. Low RS will receive hormonal rx while high RS will receive chemotherapy (Reference #9935/8981)
CTSU SWOG S0307: randomized phase III trial of bisphosphonates in stage I-III breast cancer. Patients are randomized to one of three arms (either IV or PO), in addition to standard therapy (Reference # 7383)
IGSP: DOD NEO BREAST MARCOM: Randomized phase II trial evaluating the performance of genomic expression profiles to direct use of preoperative chemo for early stage breast (Reference # 1345)
INHIBIN AB: Inhibin A/B levels as predictors of premature ovarian failure in operable breast cancer (Reference # 10675/5335)
CTSU SWOG S0500: Randomized phase III trial to test the strategy of changing therapy versus maintaining therapy for metastatic breast pts who have elevated circulating tumor cell levels at first follow-up assessment (Reference #13423)
CALGB 40302: A randomized, double blind, placebo controlled phase III trial of Fulvestrant +/- Lapitinib for postmenopausal women with ER/PR+, HER2 negative or positive advanced breast cancer (Reference # 6068)
Lung
IGSP: TOP 0703 (Ready NSCLC): Genomic profile directed treatment with cisplatin based chemo with either vinorelbine or pemetrexed, adjuvant treatment of patients with resected stage IB (> 4cm), II, or IIIA NSCLC. Fresh frozen tissue at time of resection required -- patients to come to Duke for surgery (Reference #0657)
IGSP: TOP 0602 (Potti NSCLC): Evaluating the role of pemetrexed + gemcitabine in the initial treatment of select stage IIIB/IV NSCLC, using a genomic predictor of platinum resistance to guide therapy. Fresh frozen tissue required, biopsy to be done at Duke (Reference # 4599)
IGSP: TOP 0801 (Kelley Dasatinib NSCLC): Dasatinib in previously treated patients with adv NSCLC (Reference # 8303)
Gastrointestinal
XELOXA GASTRIC: Oxaliplatin, bevacizumab, xeloda in the treatment of metastatic esophagogastric adenocarcinomas (Reference # 8710/8797)
CTSU ECOG 5202: Treatment of stage II colon cancer at risk for recurrence determined by tissue submission. Treatment 5-FU, Leucovorin, and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab (Reference # 5437/8382)
Prostate
CALGB 90202: A randomized double-blind, placebo-controlled phase III study of early versus standard Zoledronic acid to prevent skeletal events in prostate cancer metastatic to bone (Reference # 9388/7514)
Multiple Myeloma/MDS/Lymphoma
BAYER SORAFENIB MDS: A phase II trial of sorafenib in MDS. All prior treatment except transplant allowed (Reference # 8151/8622)
CELGENE MYELOMA: Lenalidomide/low dose dexamethasone induct tx followed by low dose melphalan, prednisone, lenalidomide and bortezomib sequential maintenance tx for newly diagnosed high-risk myeloma (Reference # 2869)
MILLENIUM VELCADE: Bortezomib in combo with Rituximab, Fludarabine, Mitoxantrone & Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma (Reference #8487/8785)
