Solid Tumor Trials

MBRCC Open Clinical Trials List – January 2015
Solid Tumor
Brain/CNS
Adjuvant
Phase 3
A221101 - A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in
Patients with Glioblastoma Multiforme Javier Gonzalez, MD; Sylvia McEwuen, RN
Breast Cancer
Neo-Adjuvant
Locally Advanced - Phase 3
A011202 - A Randomized Phase III Trial Evaluating The Role Of Axillary Lymph Node Dissection In Breast Cancer Patients (cT1-3 N1) Who Have
Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy Jessica Partin, MD; Cortney Montgomery, RN
NSABP-B52 - A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive,
HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab,
and Pertuzumab (TCHP) With or Without Estrogen Deprivation Adham Salkeni, MD; Cortney Montgomery, RN
NSABP-B51/RTOG-1304 - A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and PostLumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically
Negative Axillary Nodes After Neoadjuvant Chemotherapy Jessica Partin, MD; Cortney Montgomery, RN
Adjuvant
Phase 3
NSABP-B47 - A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus
Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in
Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Adham Salkeni, MD; Cortney Montgomery, RN
1
MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/
MBRCC Open Clinical Trials List – January 2015
S1207- Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in
Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Sobha Kurian, MD; Cortney
Montgomery, RN
Metastatic
1st Line
ML28257 - An Observational Cohort Study Of Treatment Patterns And Outcomes In Patients With HER2 Positive (HER2+) Metastatic Breast
Cancer Adham Salkeni, MD; Cortney Montgomery, RN
GO29227 - A randomized, Phase 2, Multicenter, Placebo-Controlled study of Ipatasertib (GDC-0068), an inhibitor of AKT, in combination with
paclitaxel as front-line treatment for patients with metastatic triple-negative breast cancer. Adham Salkeni, MD; Cortney Montgomery, RN
2nd Line + Phase 3
PUMA-NER-1301- A Study Of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine In Patients With HER2+ Metastatic Breast Cancer
Who Have Received Two or More Prior HER2-Directed Regimens In The Metastatic Setting (NALA) Adham Salkeni, MD; Cortney Montgomery,
RN
Other
A011104 - Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer Ginger Layne, MD;
Cortney Montgomery, RN
WVU011113 - Tissue Procurement for Laboratory Studies Involving Novel Therapies for Breast Cancer Hannah Hazard, MD; Cortney
Montgomery, RN
WVU011112 - Validation of a Novel Marker Associated with Risk for Delayed Chemotherapy-induced Vomiting (CIV) (Breast) Gerald Higa,
PharmD; Karen Stauffer, RN
WVU011513 - Automated breast ultrasound in the evaluation of occult sites of breast cancer in women with unilateral biopsy-proven breast cancer
or highly suspicious breast lesion Ginger Layne, MD
WVU011013 - Mastering Your Mind - Provide free evidence-based PST-OT and computerized cognitive training program for persons with cancertherapy-associated cognitive change. Anne Cronin, PhD
WVU011414 - Title Time course of upper extremity functional recovery following mastectomy Anne Swisher, PhD
2
MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/
MBRCC Open Clinical Trials List – January 2015
Colon
Metastatic
STX0112 - Assessment of Overall Survival of FOLFOX6m plus SIR-Spheres microspheres versus FOLFOX6m alone as first-line treatment in
patients with non-resectable liver metastases from primary colorectal carcinoma in a randomized clinical study Patricia Stoltzfus, MD; Carla
Ross, RN
Head and Neck
Adjuvant
Locally Advanced - Phase 3
RTOG-0920 - A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Manish Monga, MD; Toni Bulian, RN
E1311 - A Randomized, Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients with
Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence Manish Monga, MD; Toni Bulian, RN
RTOG1216 - Randomized Phase II/III Trial of Surgery and Postoperavtive Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus
Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck Manish Monga, MD; Toni Bulian, RN
Metastatic
Phase 3
ECOG1305 - A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and
Neck Cancer Manish Monga, MD; Toni Bulian, RN
Other
WVU011614 - Pilot Study of Metformin (MF) in HNSCC (Head and Neck Squamous Cell Carcinoma) as Window Trial Design in Operable HNSCC
to Investigate the Effects of MF Tumor Genotype and MF-genotype Interactions on Tumor Metabolism and Aniokis. Manish Monga, MD; Toni
Bulian, RN
3
MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/
MBRCC Open Clinical Trials List – January 2015
Kidney (Renal Cell) Cancer
Phase 2
ECOG1808 - A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
Thomas Hogan, MD; Carla Ross, RN
Lung Cancer –NSCLC (Non Small Cell)
Radiation Therapy
Phase 1
WVU020513 - Phase I Dose Escalation Study of a Hypofractionated Stereotactic Boost (HySBst) to the Primary Site in Patients with Stage II-III
Non-small Cell Lung Cancer Alexander Chi, MD; Carla Ross, RN
Phase 2
WVU010513 - A Phase II Clinical Trial of Image Guided Stereotactic Ablative Radiotherapy SABR) for T2 and microscopic T3 (PL3), N0,M0 Nonsmall Cell Lung Cancer (NSCLC) Alexander Chi, MD; Carla Ross, RN
Metastatic
st
1 Line
Phase 2
E2511 - Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as
Frontline Therapy for Extensive Stage Small Cell Lung Cancer Manish Monga, MD; Carla Ross, RN
Phase 3
ECOG5508 - Randomized Phase III Study of Maintenance Therapy with Bevacizumab,Pemetrexed, or a Combination of Bevacizumab and
Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC Mohammed Almubarak, MD; Carla
Ross, RN
4
MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/
MBRCC Open Clinical Trials List – January 2015
2nd or 3rd Line - Phase 3
D1532C00079 - A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244;
ARRY-142886) d-Sulfate) in Combination with Docetaxel, in Patients receiving second e treatment for KRAS Mutation-Positive Locally Advanced
or Metastatic Non-Small Cell Lung Cancer (Stage IIIB – IV) (SELECT-1) Mohammed Almubarak, MD; Carla Ross, RN
9090-14 - A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel versus Docetaxel Alone in Patients With Advanced NonSmall-Cell Lung Adenocarcinoma Manish Monga, MD; Carla Ross, RN
Melanoma
ECOG3612 - A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV
Melanoma Manish Monga, MD; Carla Ross, RN
5
MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/
MBRCC Open Clinical Trials List – January 2015
Contacts
Principal Investigators
Email
Phone
Mohammed Almubarak, MD
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
304-293-4229
Miklos Auber, MD
Alexander Chi, MD
Anne Cronin, PhD
Hannah Hazard, MD
Javier Gonzalez, MD
Gerald Higa, PharmD
Thomas Hogan, MD
Geraldine Jacobson, MD
Sobha Kurian, MD
Ginger Layne, MD
Manish Monga, MD
[email protected].edu
304-293-4229
304-293-7826
304-293-0443
304-293-2380
304-293-3527
304-293-1461
304-293-4229
304-293-7227
304-293-4229
304-293-3091
304-293-4229
Patricia Stoltzfus, MD
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
Anne Swisher
[email protected]
304-293-1319
Study Coordinators
Email
Phone
Trish Beal, RN
Toni Bulian, RN
Sylvia McEwuen, RN
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
304-293-0609
304-293-2633
304-293-1683
Jessica Partin, MD
Adham Salkeni, MD
Brent Steadman, MD
Cortney Montgomery, RN
Carla Ross, RN
304-293-7095
304-293-4229
304-293-3091
304-293-3091
304-293-7375
304-581-1158
6
MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/