Today, we have new and better ways to treat cancer. Physicians at the Leo W. Jenkins Cancer Center are determined to make sure that patients receive the very best and very latest of those treatments. Clinical Trials are part of the process that leads to new treatments or preventive measures for disease. When a new procedure or therapy shows promise, it is evaluated in a carefully controlled, clinical setting to determine if it is effective. In cancer cases, trials may involve new drug therapies, surgical techniques or new combinations of common treatments like radiation, chemotherapy, and surgery.

Because the Leo W. Jenkins Cancer Center is accredited as an academic cancer center, it is able to offer clinical trials. By offering clinical trials we are able to bring hope to the people of this region. The center also provides information about clinical trials to the community through outreach clinics and support to local physicians.

At our center, more than 8 percent of patients take part in trials. Many trials show great promise, and we are working every day to make sure that people in eastern North Carolina who wish to, have an opportunity to participate in clinical trials.

Specialists at our cancer center have joined leaders from other major cancer centers across the country to organize Clinical Trials Cooperative Groups. In addition to these cooperative group trials, our center also participates in studies sponsored by pharmaceutical companies.

These clinical research studies are monitored carefully by review committees both at this center and at the National Cancer Institute. Our Institutional Review Board (IRB) is located at the Ed Warren Life Sciences Building and includes doctors and other health professionals who protect the rights and welfare of patients participating in clinical trials.

The following link to the National Cancer Institute has questions and answers on clinical trials.

For more information on the clinical trials currently open at the Leo W. Jenkins Cancer Center, please contact:

Anastasia Sigounas BS, CCRC
Administrative Manager
Regulatory and Contracts / Budgets
Office: 252-744-0282
Pager: 252-383-2314
sigounasa@ecu.edu

 

Jackie Unger, RN, OCN
Clinical Trials Nurse Manager
Clinical Trials Nurse Coordinator
Office: 252-744-9016
Pager: 252-383-0184
ungerj@ecu.edu

 

Susan Eubanks, RN, BSN, OCN
Clinical Trials Nurse Coordinator
Office:  252-744-1015
Pager:  252-383-0432
eubankss@ecu.edu

 

Denise Brigham, RN, MPH
Clinical Trials Nurse Coordinator
Office: 252-744-5138
Pager: 252-383-1414
brighamd@ecu.edu

 

Sue Ann Joyner, MS
Regulatory Coordinator
Office: 252-744-9010
joyners@ecu.edu

 

Hollie Wooten, BS
Regulatory Coordinator
Office: 252-744-0320
massenburgwootenh@ecu.edu

 

Douglas Mills, CPhT
Clinical Research Assistant
Office:  252-744-4924
millsd@ecu.edu

 

Glenda Daniels
Administrative Assistant
252-744-4929
danielsg@ecu.edu

---

Clinical Trials Open:
(all Clinical Trials that are open may not be listed)

______________________________________________________________________________

Breast

Protocol: NSABP B43:

 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

PI: Rachel Raab, MD

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=615085&version=HealthProfessional&protocolsearchid=8079308

Protocol: LJCC 0703:

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

PI: Paul Walker, MD

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=573471&version=HealthProfessional&protocolsearchid=8079308

Protocol: SWOG  S0500:

Randomized Phase III Trial to Test the Strategy of Changing Therapy Vs. Maintaining Therapy for Metastatic Breast Cancer Patients who have Elevated Circulating Tumor Cells Levels at First Follow-Up Assessment

PI: Rachel Raab, MD

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=528955&version=HealthProfessional&protocolsearchid=8079308

Protocol:  CALGB 40601:

Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib, or both as Neoadjuvant treatment of HER 2-Positive Primary Breast Cancer

 PI:  Rachel Raab, MD

http://www.cancer.gov/clinicaltrials/search/view?cdrid=616648&version=HealthProfessional&protocolsearchid=10034829

 Protocol:  CALGB 70604:

CALGB 70604:Randomized Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

PI:  Rachel Raab, MD

http://www.cancer.gov/clinicaltrials/search/view?cdrid=637947&version=HealthProfessional&protocolsearchid=10034837

______________________________________________________________________________

 Bladder

Protocol:  CALGB 90601:

 A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab To Gemcitabine, Cisplatin, And Placebo With Advanced Transitional Cell Carcinoma

 PI:  Prashanti Atluri, MD

 http://www.cancer.gov/clinicaltrials/search/view?cdrid=649174&version=HealthProfessional&protocolsearchid=10034853

 ______________________________________________________________________________

Colon & Pancreatic

Protocol:  LCCC 0831:

Mechanisms of Venous Thromboembolism in Cancer

PI:  Prashanti Atluri, MD

Protocol:  RTOG 0848:

 A Phase III Trial Evaluating Both Erlotinib And Chemoradiation As Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma

PI:  Tithi Biswas, MD

Protocol:  LCCC 1029

A Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Versus Placebo With FOLFIRI as Second-Line Therapy in Patients with K-RAS or BRAF Mutant Metastatic Colorectal Cancer

PI:  Prashanti Atluri, MD

______________________________________________________________________________

Colorectal

Protocol: LCCC 0918:

Multicenter Study Investigating Utilization Of Pharmacokinetic-Guided 5-Fluorouracil In Patients Receiving MFOLFOX6 With or Without Bevacizumab

PI: Prashanti Atluri, MD

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=681338&version=HealthProfessional&protocolsearchid=8083066

Protocol:  LCCC0809: 

A Dose Finding Safety and Preliminary Efficacy Study of Stereotactic Radiosurgery for Hepat-Cellular Carcinoma and Colorectal Liver Metastases

PI:  Tithi Biswas, MD

______________________________________________________________________________

Leukemia

Protocol: LJCC 0605:

Phase II Trial of Daily Pulse Interlukin-2 w/ Famotidine in AML

PI: Paul Walker, MD

Protocol: CALGB 10403:

An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)

PI: Adam Asch, MD

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=574230&version=HealthProfessional&protocolsearchid=8079620

Protocol:  CALGB 10404

A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients With Symptomatic, Previously Treated Chronic Lymphocytic Leukemia

PI:  Adam Asch

http://www.cancer.gov/clinicaltrials/search/view?cdrid=584205&version=HealthProfessional&protocolsearchid=10034912

_____________________________________________________________________________

Lung

Protocol: LJCC 0701:

Phase II Trial of Pulsed Paclitaxel with Concurrent Thoracic Radiotherapy & Adjuvant Gemcitabine & Carboplatin in Stage IIIA & IIIB Non-Small Cell Lung Cancer

PI: Paul Walker, MD

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=540511&version=HealthProfessional&protocolsearchid=8079639

Protocol:  CALGB 30607

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC # 736511, IND # 74019) As Maintenance Therapy In Non-Progressing Patients Following An Initial Four Cycles Of Platinum-Based Combination Chemotherapy In Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer

 PI:  Paul Walker, MD

http://www.cancer.gov/clinicaltrials/search/view?cdrid=597649&version=HealthProfessional&protocolsearchid=10034883

_____________________________________________________________________________________

Lymphoma

Protocol:  LCCC 1011:

A Phase II Trial of Bendamustine in Combination with Rituximab in Older Patients with Previously Untreated Large B-Cell Lymphoma

 ______________________________________________________________________________

 Pancreas

Protocol:  PEREGRINE:

A Randomized Open-Label Phase 2 Trial of Gemcitabine With or Without bavituximab in Patients with Previously Untreated Stage IV Pancreatic Cancer

PI:  Pamela Lepera, MD

Protocol:  RTOG 0848:

A Phase III Trial Evaluating Both Erlotinib And Chemoradiation As Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma

PI:  Tithi Biswas, MD

http://www.cancer.gov/clinicaltrials/search/view?cdrid=659092&version=HealthProfessional&protocolsearchid=10034919

______________________________________________________________________________