Open for Accrual June 1, 2008
Research Projects by Attending Physicians On Staff at Inova Fairfax Hospital Cancer Center
This list of open research trials is meant to be a general information resource only. This information is updated on a monthly basis. It should not replace or supercede information given by the patient's 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. General information regarding clinical trials for patients can be found here. The U.S. government has a clinical trials web site that might also prove a helpful resource 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.
Site: Translational Research
Organization: Inova/George Mason University Translational Research Institute Title: 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 Investigators: Kirsten Edmiston, MD, FACS, and Vikas Chandhoke, PhD Contact Person: Stacey Banks, 703-776-3565
Organization: International Genomics Consortium (IGC) Title: The Expression Project for Oncology (expO) Purpose: To perform gene expression analysis on breast, lung, colon, ovary and prostate tumors and make all data publicly available with no intellectual property restrictions Principal Investigator: Nicholas Robert, MD Contact Person: Stacey Banks, 703-776-3565
Site: Breast—Ductal Carcinoma in Situ
Organization: Inova/GMU Translational Research Institute Title: Molecular Network Profiling of DCIS for Patient Stratification and Individualized Therapy Principal Investigator: Kirsten Edmiston, MD, FACS Contact Person: Barbara Merritt, RN, BSN, 703-776-3551
Organization: Inova/GMU Translational Research Institute/Dept. of Defense Title: DCIS Stem Cells: A New Paradigm for Invasion and Metastasis Purpose: To identify and propagate DCIS derived neoplastic stem cells to assess growth and metastasis. Principal Investigator: Kirsten Edmiston, MD; Lance Liotta, MD Contact Person: Barbara Merritt, RN, BSN, 703-776-3551
Site: Breast—Molecular Networks
Protocol: Inova/GMU Translational Research Institute Title: Impact of Oral Hypoglycemic Usage on Breast Cancer Gene Expression Patterns Principal Investigator: Kirsten Edmiston, MD, FACS Contact Person: Stacey Banks, 703-776-3565
Site: Breast—Adjuvant
Protocol: NCI Title: JMA17R Ph III Letrozole vs Placebo in Women w/5+ years Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: US Oncology 05-145 Title: A Randomized, Double-blind, Multicenter, Placebo–Controlled Study of Adjuvant Lapatinib in Women with Early-Stage ErbB2 Overexpressing Breast Cancer Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: US Oncology 06-038 Title: A Phase II Trial of Adjuvant TC (Docetaxel/Cyclophosphamide) plus Trastuzumab in HER2-Positive Early Stage Breast Cancer Patients Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258 Nearing Total Accrual — 'Call Manager' status
Protocol: US Oncology 06-090 Title: A Phase III Trial of Adjuvant TC versus TAC in HER2-Negative Early Stage Breast Cancer Patients Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: ECOG Title: TAILORx - Trial Assigning Individualized Options for Treatment in Cancer Patients with Node -, ER+, PR+ Breast Cancer Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: ECOG E5103 Title: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel and Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer Principal Investigator: Mary Wilkinson, MD Contact Person: Carol Hatch, RN, 703-720-5210
Protocol: SWOG S0307 Title: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer Principal Investigator: Mary Wilkinson, MD Contact Person: Carol Hatch, RN, 703-720-5210
Site: Breast—Metastatic
Protocol: US Oncology 07-040 Title: A Phase II, Multi-center, Open-Label, Randomized Trial of Gemcitabine/Carboplatin, with or without BSI-201, in patients with ER, PR, and HER2-negative Metastatic Breast Cancer Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: US Oncology 07-067 Title: A Phase II, Single-Arm, Open-Label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients with HER2-Positive Metastatic Breast Cancer Who Have Progressed while Receiving HER2-Directed Therapy Principal Investigator: Nicholas Robert, MD Contact Persons: Ellen Ritter, RN, 703-208-9258 or Julie Baumgardner, RN, 703-208-9260
Protocol: US Oncology 07-036 Title: Taxol+Sutent v Taxol+Avastin Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: Georgetown 2004-251 Title: Phase I/II Trial of Sorafenib in combintion with Anastrozole in Patients with Metastatic Breast Cancer Principal Investigator: Mary Wilkinson, MD Contact Person: Carol Hatch, RN, 703-720-5210
Protocol: Georgetown 2005-200 Title: Circulating Tumor Cells: Assessment of Treatment Efficacy in Metastatic Breast Cancer Principal Investigator: Mary Wilkinson, MD Contact Person: Carol Hatch, RN, 703-720-5210
Site: Bladder/Gastric/Esophageal/Ovarian/ Uterine
Protocol: US Oncology 06-155 Title: Randomized Discontinuation of Lapatinib in ErbB2+ Patients Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: US Oncology 06-063 Title: Phase II Docetaxel+Oxali+Cetux Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Site: Colorectal Cancer No studies at this time.
Site: Lung—Adjuvant
Protocol: START Title: Study of vaccine STIMUVAX in Pts with Unresectable Stage III Disease Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Protocol: HGS Title: Ph II Mapatumumab + Carboplatin + Paclitaxel (Fairfax office only) Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Site: Multiple Myeloma
Protocol: US Oncology 06-108 Title: Randomized Phase IIIb Study of Three Treatment Regimens in Subjects with Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE® (Bortezomib), Thalidomide, and Dexamethasone (VTD) versus VELCADE® and Dexamethasone (VD) versus VELCADE®, Melphalan and Prednisone (VMP) Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Site: Ovarian/Fallopian Tube or Peritoneal Cancer
Protocol: Gynecological Oncology Group (GOG 0209) Title: Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients with Stage III and IV or Recurrent Endometrial Cancer Principal Investigator: John C. Elkas, MD Contact Person: Sheila Whitt, RN703-698-7100
Protocol: Gynecological Oncology Group (GOG 212) Title: 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 ovarian peritoneal cancer who achieve a complete clinical response to primary platinum/taxane chemotherapy Principal Investigator: John C. Elkas, MD Contact Person: Sheila Whitt, RN, 703-698-7100
Protocol: Gynecological Oncology Group (GOG 218) Title: A Phase III Trial of carboplatin and paclitaxel plus placebo versus carboplatin and paclitaxel plus concurrent bevacizumab followed by placebo, versus carboplatin and paclitaxel, plus concurrent and extended bevacizumab, in women with newly diagnosed, previously untreated, stage III (suboptimal) and all stage IV, epithelial ovarian or primary peritoneal cancer Principal Investigator: John C. Elkas, MD Contact Person: Sheila Whitt, RN, 703-698-7100
Protocol: Gynecological Oncology Group (GOG 0219)Title: Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis Principal Investigator: John C. Elkas, MD Contact Person: Sheila Whitt, RN, 703-698-7100
Protocol: Novartis Title: A randomized, parallel group, open-label, active controlled, multi-center 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 Principal Investigator: Annette Bicher, MD Contact Person: Sheila Whitt, RN, 703-698-7100
Protocol: Genetech Title: A Phase II multi-center, Randomized, blinded, placebo-controlled trial of Carboplatin and Gemcitabine plus Bevacizumab in patients with platinum sensitive recurrent ovary, primary peritoneal, or fallopian tube carcinoma Primary Investigator: Annette Bicher, MD Contact Person: Sheila Whitt, RN, 703-698-7100
Protocol: Marshall Edwards OVATURE Title: Phase III Efficacy Study comparing Phenoxodiol (oral dose form) in combination with Carboplatin with placebo in patients with platinum-resistant or platinum-refractory late stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy Primary Investigator: Annette Bicher, MD Contact Person: Sheila Whitt, RN, 703-698-7100
Site: Prostate
Protocol: US Oncology 07-068 Title: A Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study Comparing AT-101 in Combination with Docetaxel and Prednisone versus Docetaxel and Prednisone in Men with Chemotherapy Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC) Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Site: Sarcoma
Protocol: ARAID Title: Efficacy of AP23573 for Patients Completing 1, 2, or 3 Lines of Prior Therapy Achieving SD, PR, or CR (Fairfax office only) Principal Investigator: Nicholas Robert, MD Contact Person: Ellen Ritter, RN, 703-208-9258
Site: Advanced Cancers
No studies at this time.