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Cancer Clinical Trials for Adults

Last updated August 2013

Cancer-related research projects by attending physicians on staff at Inova Comprehensive Cancer and Research Institute and Inova Women's Services

This list of open research trials is meant to be a general information resource only. It should not replace information given by your physician. These studies may close without warning.

In addition to the consent forms for these studies, additional general disease information
can be found at www.cancer.gov. Inova Research Center provides general information
regarding clinical trials for patients. The U.S. government has a clinical trial website
with helpful information for patients. It allows people to look for trials in specific therapeutic
areas: www.clinicaltrials.gov. The National Cancer Institute also has trial search engines and
information on clinical trials.

For questions regarding the status of an individual study, please contact the person listed with
each individual study.

Translational Research

Protocol/Organization Study Title/Purpose Status
Inova/George Mason University
Transitional Research Institute
Cancer Molecular Profiling Project
Purpose: To study the phosphoproteomic profile of brain, ovarian, colorectal, liver, lung and hematogenous malignancies to classify disease and develop treatments using microarray technology
Principal Investigator: Kirsten Edmiston, MD
Contact Person: Holly Gallimore, 703-776-2688
Open

Acute Myeloid Leukemia

Protocol/Organization Study Title/Purpose Status
GSK PMA112509
A Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects with Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia after MDS (sAML/MDS)
Principal Investigator: John Feigert, MD
Contact Person: Stacey Banks, 703-208-3148
Open

Site: Bladder

Protocol/Organization Study Title/Purpose Status
US Oncology 09-217
An Open-label, Multi-center, Randomized Phase II Study Evaluating the Safety and Efficacy of Docetaxel in Combination with Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 or Without Investigational Therapy as Second-line Therapy in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter or Renal Pelvis Following Disease Progression on Firsty-line Platinum-based Therapy
Principal Investigator: Alexander Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open

Site: Breast – Ductal Carcinoma in Situ

Protocol/Organization Study Title/Purpose Status
Inova/George Mason University
Preventing Invasive Breast Neoplasia with Chloroquine (PINC) Trial
Purpose: To study the use of chloroquine in the treatment of ductal carcinoma in situ (DCIS) and in prevention of invasive breast cancer in patients diagnosed with DCIS.
Principal Investigator: Kirsten Edmiston, MD
Contact Person: Holly Gallimore, 703-776-2688
Open


Site: Breast – Neoadjuvant

Protocol/Organization Study Title/Purpose Status
ISPY-2
ISPY-2 Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis
Purpose: To study multiple novel agents in locally advanced breast cancer patients receiving neoadjuvant chemotherapy.
Principal Investigator: Kirsten Edmiston, MD
Contact Person: Holly Gallimore, 703-776-2688; Janine Prime, 703-208-3107; Clara Tran, RN, 703-720-5210
Open


Site: Breast – Adjuvant

Protocol/Organization Study Title/Purpose Status
US Oncology 07-132 A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC, for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
RTOG 1005 A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost versus Standard Whole Breast Irradiation Plus Sequential Boost For Early-Stage Breast Cancer

This study is open to enrollment at the following sites:

Inova Fairfax Hospital
Principal Investigator: Samir Kanani, MD
Contact Person: Christina Krawiecki, CCRC, 703-776-4021

Inova Fairfax Hospital
Principal Investigator: Samir Kanani, MD
Contact Person: Christina Krawiecki, CCRC, 703-776-4021

Inova Alexandria Hospital
Principal Investigator: Jane Grayson, MD
Contact Person: Chloe Hamilton, RN, 703-504-7916 and 703-504-7900
Open


Site: Breast – Locally Recurrent or Metastatic

Protocol/Organization Study Title/Purpose Status
US Oncology 08-223   A Randomized, Phase III, Double-Blind, Placebo-Controlled Multi-Center Trial of Daily Everolimus in Combination with Trastuzumab and Vinorelbine, in Pretreated Women with HER2/neu Over-Expressing Locally Advanced or Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
US Oncology 09-097  A Randomized, Phase III, Open-Label Study of Lapatinib plus Trastuzumab versus Trastuzumab as Continued HER2 Suppression Therapy after Completion of First- or Second-line Trastuzumab Plus Chemotherapy, in Subjects with HER2- Positive Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
US Oncology 09-185 2010EAP: An Open-Label, Expanded Access Protocol of Iniparib in Combination with Gemcitabine/Carboplatin in Patients with ER-, PR-, and HER2-Negative Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
SIDE-OUT A Pilot Study Utilizing Molecular Profiling by IHC, FISH, DNA Microarray, and Reverse Phase Protein Microarray (RPMA) of Patients' Tumors to Find Potential Targets and Select Treatments, for Patients with Metastatic Breast Cancer
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148 
Open
TRIO 018 (A5481003) Phase I/II, Open-Label, Randomized Study of the Safety, Efficacy, and Pharmacokinetics of Letrozole Plus PD 0332991 (Oral CDK 4/6 inhibitor) and Letrozole Single Agent, for the First-Line Treatment of ER Positive, HER2 Negative Advanced Breast Cancer in Postmenopausal Women
Principal Investigator: Nicholas Robert, MD
Contact Person: Stacey Banks, 703-208-3148
Open
Mayo Clinic MC0738
The Effect of Anti-depressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study
Principal Investigator: Neelima Denduluri, MD
Contact Person: Stacey Banks, 703-208-3148
 Open
Novartis
CBKM120F2202
A Randomized, Double-Blind, Placebo Controlled, Phase II Study of BKM120 Plus Paclitaxel in Patients with HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
Principal Investigator: Mary Wilkinson, MD
Contact Person: Clara Tran, RN 703-720-5210
 Open
NSABP B-43
A Phase III Clinical Trial Comparing Trastuzumad Given Concurrently with Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy.
Principal Investigator: Mary Wilkinson, MD
Contact Person: Clara Tran, RN 703-720-5210
 Open


Site: CLL

Protocol/Organization Study Title/Purpose Status
US Oncology 11-078 An Open-Label, Multi-Center, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 MG versus 2000 MG in Patients with Previously Untreated Chronic Lymphocytic Leukemia
Principal Investigator: Dipti Patel-Donnelly, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Metastatic Colorectal Cancer

Protocol/Organization Study Title/Purpose Status
CALGB/SWOG C80702
A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
Principal Investigator: Mary Wilkinson, MD
Contact Person: Clara Tran, RN, 703-720-5210 
 Open
Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis from Colon Cancer with Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemothery, and Anti-Angiogenic Therapy
Purpose: The main purpose of this study is to find out if the combination of TACE and intravenous chemotherapy is safe as well as more effective than intravenous chemotherapy alone. Watch our stage 4 colon cancer or rectal cancer spread to the liver study videos.
Principal Investigator: Jim Papadouris, MD
Contact Person: Arletta van Breda, RN, MSN, CCRC, CIP, 703-504-7760 or 703-504-7950
Open
US Oncology 10-101
A Randomized, Double-Blind, Multi-Center, Phase III Study of Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients with Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy with Bevacizumab, Oxaliplatin and a Fluoropyrimidine
Principal Investigator: Alexandra Spira, MD
Contact Person: Stacey Banks, 703-208-3148
 Open
US Oncology 11-072
Phase I/II Study of PX-866 and Cetuximab for CRC and SCCHN
Principal Investigator: Alexandra Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Endometrium (Uterine)

Protocol/Organization Study Title/Purpose Status
Walter Reed
E39
Phase Ib Trial of  Folate Binding Protein (FBP) Peptide (E39)Vaccine in Ovarian and Endometrial Cancer Patients
Principal Investigator: John Elkas, MD
Contact Person: Kelly Jeffords, CCRC, CCRP, 703-698-7100, ext. 344
Open
Walter Reed Tissue and Data Acquisition for the Study of Gynecologic Disease
Principal Investigator: John Elkas, MD
Contact Person: Kelly Jeffords, CCRC, CCRP, 703-698-7100, ext. 344
Open

Natural History of Urinary Symptoms in Women Receiving Paclitaxel/Carboplatin for Treatment of Gynecologic Cancers
Principal Investigator: Walter von Pechmann, MD
Contact Person: Kelly Jeffords, CCRC, CCRP, 703-698-7100, ext. 344
Open
Caris Dx A Registry of the Target Now Test Results (Biomarker Expression Patterns) for Evaluation of Correlation with Clinical Outcomes for Cancer Patients
Principal Investigator: Annette Bicher, MD
Contact Person: Kelly Jeffords, 703-698-7100, ext. 344 
Open
Amgen A Phase 3 Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of AMG 386 with Paclitaxel and Carboplatin as First-line Treatment of Subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Principal Investigator: John C. Elkas, MD, JD
Contact Person: Kelly Jeffords, CCRC, CCRP, 703-698-7100, ext. 344
Open
VentiRX A Randomized, Double Blind, Placebo Controlled Phase II Study of VTX-2337 (IND#78,416) in Combination with Pegylated Liposomal Doxorubicin (PLD) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Principal Investigator: John C. Elkas, MD, JD
Contact Person: Kelly Jeffords, CCRC, CCRP, 703-698-7100, ext. 344
Open


Site: Interventional Radiology

Protocol/Organization Study Title/Purpose Status
  A Humanitarian Device Exemption Treatment Protocol of TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma and Tumors Metastatic to the Liver
Principal Investigator: Calvin Neithamer, MD, FACR
Contact Person: Christina Krawiecki, 703-776-4021
 Open


Site: Lung

Protocol/Organization Study Title/Purpose Status
US Oncology 08-035 A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks, in Anemic Subjects with Advanced Stage Non-Small Cell Lung Cancer Receiving Multi-Cycle Chemotherapy
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open
GSK MAGRIT 109493 A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of recMAGE-A3 + AS15 Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients with Resectable MAGE-A3-Positive Non-Small Cell Lung Cancer
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148 
Open 
US Oncology 10-061 A Randomized, Double-Blind, Phase III Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open
CP11-0806 A Randomized, Multi-Center, Open-Label, Phase III Study of Gemcitabine-Cisplatin Chemotherapy Plus IMC-11F8 versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients with Squamous Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC)
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open
US Oncology 10-090
A Phase III Randomized, Double-Blind, Placebo Controlled Study of ARQ 197 Plus Erlotinib versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Principal Investigator: Alex Spira, MD
 Contact Person: Stacey Banks, 703-208-3148
Open
US Oncology 11-064
A Phase II, Open-Lable, Multi-Center, Randomized Study to ASsess the Efficacy and Safety of GSK1120212 Compared with Docetaxel in 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC Stage III Bwet-IV)
Principal Investigator: Alex Spira, MD
 Contact Person: Stacey Banks, 703-208-3148
Open
CVTSA 12.052
A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine after Thoracoscopy
Principal Investigator: Daniel Fortes, MD
 Contact Person: Christina Krawiecki, 703-776-4021
Open


Site: Melanoma

Protocol/Organization Study Title/Purpose Status
US Oncology 10-052 An Open-Label, 2-Cohort, Multi-Center Phase II Study of E7080 in Previously Treated Subjects with Unresectable Stage III or Stage IV Melanoma
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Multiple Myeloma

Protocol/Organization Study Title/Purpose Status
Multiple Myeloma Research Foundation MMRF 11-001 A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship Between Patient Outcomes, Treatment Options and Molecular Profiles
Principal Investigator: Gregory Orloff, MD
Contact Person: Stacey Banks, 703-208-3148 
Open
Merck V212-001 A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-center Clinical Trial to Study the Safety, Tolerability, Efficacy and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)
Principal Investigator: Gregory Orloff, MD
Contact Person: Stacey Banks, 703-208-3148 
Open
Oncotherapeutics IST-CAR-5168 A Phase I/II Study of Carflizomib as a Replacement for Bortezomib for Multiple Myeloma Patients Failing Borezomib-Containing Regimens
Principal Investigator: Dipti Patel-Donnelly, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Myelodysplastic Syndrome

Protocol/Organization Study Title/Purpose Status
GSK PMA112509 A Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects with Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia after MDS (sAML/MDS)
Principal Investigator: John Feigert, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Nonlymphomatous Cancers

Protocol/Organization Study Title/Purpose Status
US Oncology 11-107 Screening Protocol to Detect Tumor Antigen Expression Required for Enrollment on Clinical Research Protocols of Antibody-Directed Therapy
Principal Investigator: Dipti Patel-Donnelly, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Ovarian Cancer

Protocol/Organization Study Title/Purpose Status
Walter Reed
E39
Phase lb Trial of Folate Binding Protein (FBP) Peptide (E39) Vaccine in Ovarian and Endometrial Cancer Patients
Principal Investigator: John Elkas, MD
Contact Person: Kelly Jeffords, CCRC, CCRP , 703-698-7100, ext. 344
Open
GOG0212     A Randomized, Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax versus No Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
Principal Investigator: John Elkas, MD
Contact Person: Kelly Jeffords, CCRC, CCRP , 703-698-7100, ext. 344
Open 
 GOG0262 A Randomized, Phase III Trial of Every 3 Weeks Paclitaxel versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin with or without Concurrent and Consolidation Beyacizumab in the Treatment of Primary Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Principal Investigator: John Elkas, MD
Contact Person: Kelly Jeffords, CCRC, CCRP , 703-698-7100, ext. 344
 Open
Walter Reed
Tissue and Data Acquisition for the Study of Gynecologic Disease
Principal Investigator: John Elkas, MD
Contact Person: Kelly Jeffords, CCRC, CCRP , 703-698-7100, ext. 344
Open
Precision
Therapeutics
A Non-Interventional, Longitudinal, Multi-Center Initiative Examining Outcomes Associated with the Use of the ChemoFx Assay in Solid Tumor Malignancies
Principal Investigator: John Elkas, MD
Contact Person: Kelly Jeffords, CCRC, CCRP , 703-698-7100, ext. 344
 Open
MAPSA Natural History of Urinary Symptoms in Women Receiving Paclitaxel/Carboplatin for Treatment of Gynecologic Cancers
Principal Investigator: Walter von Pechmann, MD
Contact Person: Kelly Jeffords, CCRC, CCRP , 703-698-7100, ext. 344
 Open
Caris Dx
A Registry of the Target Now Test Results (Biomarker Expression Patterns) for Evaluation of Correlation with Clinical Outcomes for Cancer Patients
Principal Investigator: Annette Bicher, MD
Contact Person: Kelly Jeffords, CCRC, CCRP , 703-698-7100, ext. 344
 Open


Site: Pancreas

Protocol/Organization Study Title/Purpose Status
US Oncology 05-129 A Randomized Phase III Study of Weekly ABI-007 Plus Gemciabine versus Gemcitabine Alone in Patients with Metastatic Adenocarcinoma of the Pancreas
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Prostate

Protocol/Organization Study Title/Purpose Status
US Oncology 09-073 A Phase III Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone with or without Lenalidomide in Subjects with Castrate-Resistant Prostate Cancer
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open
RTOG 0534 A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy
Principal Investigator: Matt Poggi, MD
Contact Person: Chloe Hamilton, RN, BSN, OCN 703-504-7900 or703-504-7916
Open
US oncology 10-278 A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Sarcoma

Protocol/Organization Study Title/Purpose Status
US Oncology 10-237 A Phase III Multi-Center, International, Randomized, Double-Blind, Placebo-Controlled Study of Doxorubicin Plus Palifosfamide-tris versus Doxorubicin Plus Placebo in Patients with Front-Line Metastatic Soft Tissue Sarcoma
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open
Johnson & Johnson ET743-SAR-3007 A Randomized Controlled Study of YONDELIS® (Trabectedin) or Dacarbazzine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma Previously Treated With an Anthracycline and Ifosfamide
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open


Site: Squamous Cell Carcinoma of the Head and Neck

Protocol/Organization Study Title/Purpose Status
US Oncology 11-072 Phase I/II study of PX-866 and Cetuximab (CRC and SCCHN)
Principal Investigator: Alex Spira, MD
Contact Person: Stacey Banks, 703-208-3148
Open