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Clinical Trials
A clinical trial is a research study that tests new treatments. UofLs Department of Surgery provides patients with access to the latest clinical trials and treatment. For information on our current list of trials, please select from one of the categories below.
If you are considering participating in a clinical trial, you may have many questions. The National Cancer Institute has a wealth of information about clinical trials and not just about cancer-related trials. We recommend you review that site. You also can download a pdf version of NCIs Clinical Trials: Questions and Answers.
Metastatic Colorectal
Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis from Colon
Cancer with Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin chemotherapy,
and anti-Angiogenic Therapy
PI: Robert C.G. Martin, II, M.D., Ph.D.
RC: Tiffany Metzger, (502) 629-3383
tiffany.metzger@louisville.edu
Pager 464-0242
Melanoma
Transcatheter arterial chemoembolization with doxorubicin-loaded LC beads in the treatment of liver-dominant metastases in patients with stage IV metastatic melanoma: A multi-center, non-randomized, feasibility trial
PI: Robert C.G. Martin, II, M.D., Ph.D.
RC: Tiffany Metzger, (502) 629-3383
tiffany.metzger@louisville.edu
Pager 464-0242
For more details, watch our stage 4 melanoma to the liver clinical trial video
A Phase III Clinical Trial to Evaluate the Safety and Efficacy of Treatment with 2 mg Intralesional Allovectin-7ฎ Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects with Recurrent Metastatic Melanoma.
PI: Kelly M. McMasters, M.D., Ph.D.
RC: Debby Hulsewede, CCRC, CCRP (502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301
An Open, Single-Arm Study to Assess the Clinical Activity of recMAGE-A3 + AS15 in Patients with Unresectable, MAGE-A3 Positive Metastatic Cutaneous Melanoma
PI: Kelly M. McMasters, M.D., Ph.D.
RC: Debby Hulsewede, CCRC, CCRP (502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301
A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of recMAGE-A3 + AS15 ASCI as Adjuvant Therapy in Patients with Mage-A3-Positive Resected Stage III Melanoma
PI: Kelly M. McMasters, M.D., Ph.D.
RC: Debby Hulsewede, CCRC, CCRP
(502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301
Pancreas
A Phase II Study of Low Dose Hyperacuteฎ-Pancreatic Cancer Vaccine in Subjects with Surgically Resected Pancreatic Cancer
PI: Charles R. Scoggins, M.D., MBA
RC: Debby Hulsewede, CCRC, CCRP (502) 629-3308
Deborah.hulsewede@nortonhealthcare.org
Pager 299-1301
A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Carcinoma
PI: Robert C.G. Martin, II, M.D., Ph.D.
RC: Susan Ellis, RN, (502) 629-3384
mailto:susan.ellis@louisville.edu
pager 478-1235
Clinical Evaluation of Neaodjuvant Gemcitabine, Docetaxel, and Capecitabine with Concurrent Radiation for Patients with Potentially Resectable Pancreatic Carcinoma
PI: Robert C.G. Martin, II, M.D., Ph.D.
RC: Susan Ellis, RN, (502) 629-3384
mailto:susan.ellis@louisville.edu
pager 478-1235
Esophageal
Clinical Evaluation of Polyflexฎ Stenting in Esophageal Cancer Patients undergoing Chemotherapy and/or Radiation Therapy
PI: Robert C.G. Martin, II, M.D., Ph.D.
RC: Susan Ellis, RN, (502) 629-3384
mailto:susan.ellis@louisville.edu
pager 478-1235
A Phase II Study of Neoadjuvant Therapy with Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients with Locall Advanced Adenocarcinoma of the Distal Esophagus
PI: Robert C.G. Martin, II, M.D., Ph.D.
RC: Susan Ellis, RN, (502) 629-3384
mailto:susan.ellis@louisville.edu
pager 478-1235
Hepatocellular
A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma after Surgical Resection or Local Ablation
PI: Robert C.G. Martin, II, M.D., Ph.D.
RC: Susan Ellis, RN, (502) 629-3384
mailto:susan.ellis@louisville.edu
pager 478-1235
Head and Neck
A Randomized Phase II Trial of Chemoradiotherapy versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck
PI: William Spanos, MD
RC: Stacy Baum, RN,
(502) 562-3429
Vascular
Evaluation of Vascutek Rapidax in Comparison to Vascutek MAXIFLO Wrap for Hemodialysis Applications - Rap-001
Principal Investigator: Amit J. Dwivedi, M.D.
Sponsor: Sulzer Vascutek
Status: enrollment completed, study closed 2009
CHOICE: Carotid Stenting for High Surgical Risk Patients: Evaluating Outcomes Through the Collection of Clinical Evidence
Principal Investigator: Charles B. Ross, M.D.
Sponsor: Abbott Laboratories
Status: Active
CABANA: Carotid Stenting Boston Scientific Surveillance Program
Principal Investigator: Charles B. Ross, M.D.
Sponsor: Boston Scientific
Status: Closed
iCAST Atrium Registry Ultrasound Study (iCARUS)
Principal Investigator: Charles B. Ross, M.D.
Sub-investigator: Amit J. Dwivedi, M.D.
Sponsor: Atrium Medical
Status: closed
Biomet MarrowStimTM Peripheral Arterial Disease IDE Trial
Principal Investigator: Charles B. Ross, M.D.
Sub-investigator: Amit J. Dwivedi, M.D.
Sponsor: Biomet Biologics Inc.
Status: Active
Multicenter,Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of SingleDose of PRT-201 Administered Immediately after Arteriovenous Graft Creation inPatients with Chronic Kidney Disease
PrincipalInvestigator: Amit J. Dwivedi, M.D.
Sub-investigators:Charles B. Ross, M.D. and Andrea E. Yancey, M.D.
Sponsor:Proteon Therapeutics, Inc
Status:Active
AcuteVenous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis
PrincipalInvestigator: Charles B. Ross, M.D.
Sub-investigators: Amit J. Dwivedi, M.D., Andrea E. Yancey, M.D. and Marvin E. Morris, M.D.
Sponsor:?????
Status:In IRB review
TGIAdipose-derived Stromal Cell (ASC)-coated Peripheral Vascular Graft (PVG)
PrincipalInvestigator: Charles B. Ross, M.D.
Sub-investigators:Amit J. Dwivedi, M.D., Andrea E. Yancey, M.D. and Marvin E. Morris, M.D.
Sponsor:Tissue Genesis Inc.
Status:In IRB review