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Leo W. Jenkins Cancer Center
Clinical Trials

Radiotherapy planning CT scan, LJCC
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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 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 LJCC contact:

Mindy Friday, RN, OCN
Clinical Trials Nurse
252-744-1015
pager: 252-383-0927
fridaym@ecu.edu

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

Michelle Sagraves, RN
Clinical Trials Nurse
252-744-3617
pager: 383-0325
sagravesm@ecu.edu

Kent Briley
Regulatory Coordinator
252-744-9011
brileyk@ecu.edu

Hollie Wooten
Data Manager
252-744-0320
massenburgwootenh@ecu.edu

Or call the Clinical Trials Office Switchboard at 252-744-4929

Clinical Trials Open:
(not all clinical studies may be listed)




Breast

Protocol: NSABP FRP FB-5
A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer
PI: Darla Liles, MD

Protocol: ECOG 40101
Cyclophosamide And Doxorubicin (CA) (4 Vs 6 Cycles) Versus Paclitaxel (4 Vs 6 Cycles) As Adjuvant Therapy For Women With Node-Negative Breast Cancer: A 2X2 Factorial Phase III Randomized Study
PI: Darla Liles, MD

Protocol: NSABP B-42
A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer
PI: Darla Liles, MD

Protocol: NSABP B-36
A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC), with or without Celoxib, in patients with Node-Negative Breast Cancer
PI: Darla Liles, MD

Protocol: ECOG TAILORx Trial
PACCT-1 Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
PI: Darla Liles, MD

Protocol: Myocet (STM01-102)
A Phase III, Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel versus Trastuzumab and Paclitaxel for First Line Therapy of Metastatic Breast Cancer
PI: Darla Liles, MD

Protocol: UMCIRB# 06-400
Barriers to Accrual to Clinical Trials for Breast Carcinoma in Minority Women in Eastern North Carolina
PI: Darla Liles, MD

Protocol: ImmunoGen DS-6
Analysis of Shed DS6 (CA6) in Breast Cancer Patient Plasma Samples
PI: Darla Liles, MD

Protocol: LJCC 07-03
A Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple Negative Breast Cancer
PI: Paul Walker, MD


Gastrointestinal

Colon

None At This Time

Gastric

Protocol: ECOG 80101
Phase III Intergroup Trial of Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma
PI: Ron Allison, MD


Genitourinary

Renal

Protocol: ECOG E2805
Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma
PI: Walter Quan, MD

Protocol: LJCC 07-02
ECU Experience with Inpatient Interleukin-2 in Kidney Cancer and Melanoma
PI: Walter Quan, MD

Prostate

RTOG 0521
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer.
PI: Roger Ove, MD



Gynecologic

Protocol: Perifosine
A Phase IIA Trial Of Two Schedules Of Perifosine In Patients For Whom No Standard Therapy Exists
PI: Howard Homesley, MD

Cervical

Protocol: AVF3963s
Neoadjuvant bevacizumab and carboplatin followed by concurrent bevacizumab, carboplatin and pelvic radiation therapy in the primary treatment of cervix cancer
PI: Hiram Gay, MD

Protocol: GOG 204
A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
PI: Howard Homesley, MD

Endometrial

Protocol: GOG 209
Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Vs Carboplatin/Paclitaxel in Patients with Stage III & IV or Recurrent Endometrial Cancer
PI: Howard Homesley, MD

Protocol: GOG 210
A Molecular Staging Study of Endometrial Carcinoma
PI: Howard Homesley, MD

Ovarian

Protocol: AVF4095g
A Phase II, Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinum-Sensitie Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
PI: Howard Homesley, MD

Protocol: J&J ET743-OVA-301
An Open-Label Multicenter Randomized Phase 3 Study Comparing The Combination Of DOXIL®/CAELYX® And YONDELIS™ With DOXIL®/CAELYX® Alone In Subjects With Advanced Relapsed Ovarian Cancer
PI: Howard Homesley, MD

Protocol: EFC6125
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Effects of Intravenous AVE0005 (VEGFTrap) Administered Every 2 weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
PI: Howard Homesley, MD

Protocol: Novartis CEPO906A2303
A Randomized, Parallel Group, Open-Label, Active Controlled, Multicenter Phase III Trial Of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin (Doxil?/Caelyx?) In Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian Or Primary Peritoneal Cancer
PI: Howard Homesley, MD

Protocol: ARD6122
A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients with Platinum-resistant and Topotecan- and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer
PI: Howard Homesley, MD


Head and Neck
 
Protocol: RTOG 0522:
A Randomized Phase III Trial of Concurrent Accelerated Radiation & Cisplatin vs. Concurrent Accelerated Radiation, Cisplatin and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III & IV Head and Neck  Carcinomas
PI:Roger Ove, MD
 

Hematological

Leukemia

Protocol: Trisenox:
An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination with Arsenic Trioxide Compared with Low-Dose Cytarabine Alone for the Treatment of Elderly Patients with Acute Myeloid Leukemia (AML)
PI: Adam Asch, MD

Protocol: LJCC 06-05
Phase II Trial Of Daily Pulse Interleukin-2 With Famotidine In Acute Myelogenous Leukemia
PI: Paul Walker, MD

Protocol: # 05-0388
Chemotherapy Induced Alopecia & Mucositis During AML Induction Therapy
PI: Darla Liles, MD

Protocol: Vion CLI-037
A Phase III Randomized Study Of Cloretazine (VNP40101M) and Cytosine Arabinoside (AraC) In Patients With Acute Myeloid Leukemia In First Relapse
PI: Darla Liles, MD


Lymphoma

Protocol: ECOG E4402
Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Patients with Low Tumor Burden Indolent Non-Hodgkin’s Lymphoma
PI: Charles Knupp, MD

Protocol: AMGEN 20050144
An Open-Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects with Lymphoma
PI: Darla Liles, MD


Lung

Non-small cell

Protocol: LJCC 07-01
Phase II Trial of Pulsed Paclitaxel with Concurrent Thoracic Radiotherapy and Adjuvant Gemcitabine and Carboplatin in Stage IIIA and IIIB non-Small Cell Lung Cancer
NCI Listing
PI: Hiram Gay, MD

Protocol: RTOG 0229
A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma
PI: Ron Allison, MD

Protocol: H3E-US-S082
A Phase II Randomized Open-Label Trial of Biweekly Pemetrexed + Gemcitabine vs. Pemetrexed or Premetrexed + Carboplatin in Relapsed NSCLC After Neoadjuvant or Adjuvant Chemotherapy
PI: Paul Walker, MD


Melanoma

Protocol: ECOG E2603
A Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma
PI: Lillian Burke, MD

Protocol: ECOG E1697
Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b No, T3a-b, T4a-b No, and T1-4, N1a, 2a, 3 (microscopic) Melanoma
PI: Walter Quan, MD

Protocol: LJCC 07-02
ECU Experience with Inpatient Interleukin-2 in Kidney Cancer and Melanoma
PI: Walter Quan, MD

Protocol: SYMMETRY
Randomized, Double-Blinded, Phase III Trial of STA-4783 in Combination with Paclitaxel vs. Paclitaxel Alone for treatment of Chemotherapy - Naive Subjects with Stage IV Metastatic Melanoma
PI: Walter Quan, MD


Photodynamic Therapy

Protocol: PDT ENT
Photodynamic Therapy in Dysplasia and Carcinoma-in-Situ of the Aero-Digestive tract
PI: Ron Allison, MD

Protocol: MKA Grant
Fluorescence Detection Imaging of Breast Cancer Chest Wall Recurrence for Photodynamic Therapy Treatment Field Identification
PI: Rosa Cuenca, MD

 


 
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