Virginia Oncology Associates Cancer Treatment Center

At VOA, research is a key component of our mission. Over the past several years, our oncologists have participated in a number of important clinical trials, helping further scientific knowledge about cancer and bringing the latest therapies directly to patients in our community.

Clinical trial availability is critical for cancer researchers and patients alike. It is vitally important that community-based oncology centers like ours participate in furthering cancer research through clinical testing.

Because of the vast number of trials under way at any one time, there is a great need for patients who meet participation guidelines. Community-based oncology centers play a major role in identifying patients who qualify, while also extending the reach of investigational therapies.

For example, a recent review for colorectal cancer studies at www.clinicaltrials.gov showed more than 200 trials that were recruiting patients. If these trials were to be conducted in only a handful of specialized centers:

it would take much longer to find willing and able participants to fill each study, delaying research and blocking the pipeline of new cancer-fighting drugs; and
investigational treatments and therapies would be limited to patients who either live near major teaching hospitals, or who have the means to travel to these locations and stay for extended periods of time.

That is why it is important for community-based oncology centers such as VOA to offer patients access to clinical trials. The benefits are too far-reaching for us to ignore.

And that is why research – participating in the development and discovery of new therapies that can save lives – is a critical component of our practice’s mission.

97% of people who receive treatment through a clinical trial found it to be a very positive experience. They say that they were treated with quality medical care, dignity and respect.

As part of US Oncology, one of the country’s largest networks of cancer care practices and the nation’s largest integrated cancer research program, we are able to participate in many clinical trials and provide the latest, most promising drugs and treatments to patients right here in Hampton Roads.

Since 1993, more than 30,000 patients have participated in clinical trials managed by US Oncology network practices, and the network has contributed to the development of 36 cancer-fighting drugs approved for use by the Food and Drug Administration.

WHAT ARE CLINICAL TRIALS?

Clinical trials are research studies conducted with people who volunteer to participate in the new testing of therapies. These studies often lead to the development of better therapies for cancer treatment.

HOW ARE CLINICAL TRIALS CONDUCTED?

Clinical research trials are designed by physicians and researchers, who develop an action plan (protocol) that describes what will be done in the study, how it will be conducted and why each part of the study is necessary. Each study has eligibility criteria that determine who can and cannot participate in the study, which may include type of cancer, age, gender, medical history and current health status. This protocol is used by every doctor taking part in the study.

ARE YOUR RIGHTS PROTECTED?

Clinical research trials are carefully reviewed to ensure the study is conducted fairly and that no one who decides to become a participant is likely to be harmed. A panel of doctors, leading researchers, community leaders and others review and approve the clinical trial.

Participation in clinical trials is completely voluntary. If you agree to take part in a study, your physician or nurse will give you the important facts about the study. You will also receive a written consent form explaining the study, which you will have to sign in order to participate. However, even if you sign the consent form, you may stop participating in the study at any time.

BENEFITS & RISKS

BENEFITS:

Patients receive quality care from VOA physicians and other health professionals who specialize in cancer care.
You have access to promising new therapies that doctors hope will be more effective and less toxic than the standard treatment. These therapies are not yet available to patients outside the study.
You will be contributing to greater knowledge that may help other cancer patients in the future.
You can play an active role in your cancer care by expanding your treatment options.

POTENTIAL RISKS:

Participants in randomized studies will not be able to choose the approach they receive.
Some health insurances or managed care plans may not cover all patient care costs in a study, in which case the patient would be responsible for these costs.
New treatment may have unknown side-effects or risks.
The treatment being studied may be less effective than the standard treatment for that cancer.

When making a decision to participate in a clinical trial, talk to your physician. Have all of your questions and concerns answered before choosing if taking part in a study is right for you.

ASK QUESTIONS

QUESTIONS TO ASK:

What is the purpose of this study?
Has the new treatment been tested before? If so, what are the results?
How can it help me? How will I know if the treatment is helping me?
What other treatment options are available?
How will participating in this study affect my daily life? What side effects might I experience?
Are there possible long-term risks?
Who is sponsoring this study?
What kinds of treatment, medical tests or procedures will I have during the study? How often?
Where will I receive my treatment?
Who will be in charge of my care?
How long will the study last?
Will I have to pay for any treatments, tests or other charges?
Will my health insurance cover treatments and tests I receive as part of this study?
How am I protected? Will my medical records be kept confidential?
What kind of follow-up care will I receive after the study?
When do I have to make a decision about participating?

RESOURCES FOR CLINICAL TRIAL INFORMATION

American Cancer Society
(800) 234-CANCER
www.cancer.org

CenterWatch
www.centerwatch.com

National Cancer Institute
(800) 4-CANCER
www.cancer.gov/clinicaltrials

National Library of Medicine
www.clinicaltrials.gov

The Wellness Community
www.thewellnesscommunity.org

VIRGINIA ONCOLOGY ASSOCIATES
Peninsula: (757) 873-9400
Southside: (757) 466-8683

LIST OF TRIALS CURRENTLY OFFERED AT VOA

Throughout the last century the medical community has witnessed dramatic changes in the methods of diagnosis and treatment of cancer. Cancer research is no longer conducted exclusively at large university cancer centers or major metropolitan hospitals. Virginia Oncology Associates' physicians have embraced clinical research as a critical component of community-based oncology care. Through a partnership with Duke University Oncology Consortium, National Cancer Institute and US Oncology, VOA physicians are able to provide cancer patients with innovative treatment options and therapies. Virginia Oncology Associates offers the largest clinical research program in all of Hampton Roads. You do not have to leave the area to receive premier cancer care.

If you are interested in learning more about our research program, please call the VOA Research Department:
Peninsula: (757) 873-9400
Southside: (757) 466-8683

BREAST
GYN
GASTROINTESTINAL
GENITOURINARY
LEUKEMIA & LYMPHOMA
LUNG CANCER
MULTIPLE MYELOMA
PHASE I TRIALS/SOLID TUMORS
SARCOMA
SUPPORTIVE CARE
TRANSPLANT/HIGH-DOSE
SKIN

BREAST

USO 07142: A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients with Previously Treated Metastatic Breast Cancer (MBC)

USO 08077: A Phase 2, multicenter, randomized, open-label study comparing eribulin mesylate and ixabepilone in causing or exacerbating neuropathy in patients with advanced breast cancer

CALGB 40502: A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

USO 08-217: A randomized phase III, double-blind, placebo-controlled multicenter trial of everolimus in combination with trastuzumab and paclitaxel, as first line therapy in women with HER2-positive locally advanced or metastatic breast cancer

USO 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

NSABP PROTOCOL B-43: 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

USO 07-119 (BETH Trial): A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab

CALGB 40101: Adriamycin/Cytoxan versus Taxol as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes

USO 05-074: Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women with ErbB2- (HER2/neu-) Overexpressing Invasive Breast Cancer

TailoRx;PACCT-1: Trial Assigning IndividuaLized Options for Treatment; Program for the Assessment of Clinical Cancer Tests

CTSU N063D/ALTTO BIG 2-06: A Randomized, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer / Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study

USO 06-185: Randomized Phase II Trial of Letrozole with or without Dasatinib as First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Post-Menopausal Breast Cancer that is Unresectable, Locally Recurrent or Metastatic

Duke Triple Negative (DCRO_BR-2006_01): A Phase II Study of Abraxene, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone or HER2 Receptors) Metastatic Breast Cancer

GYN

GOG 0212: 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

GASTROINTESTINAL

USO 08-113: A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

CTSU E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

CSTI571BUS282: A Phase II, Non-Randomized, Open-Label Multicenter Study of 5 year Adjuvant Imatinib Mesylate (Gleevec) in Patients at Significant Risk for Recurrence Following Complete Resection of Primary Gastrointestinal Stromal Tumor (GIST)

USO 06-063: Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) with or without Cetuximab in Patients with Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma

USO 08-142: Global Investigation of therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with SorafeNib (GIDEON)

NSABP R-04: A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum

Duke 8797: A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas

CALGB 80405: A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

GENITOURINARY

USO 06-040: Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients with Advanced/Metastatic Urothelial Carcinoma

USO 09-073: A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone with or without Lenalidomide in Subjects with Castrate-Resistant Prostate Cancer (CRPC)

HOG GU07-124: A Phase II Study of Neoadjuvant Dasatinib plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

USO 08-060: Study VEG108844, a Study of Pazopanib versus Sunitinib in the Treatment of Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma

Medivation CRPC2: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy

USO 08-029: A Phase 1b Study of LY573636-sodium in Combination with Sunitinib Malate in Patients with Metastatic Renal Cell Cancer

USO 08-036 (Coming Soon): Axitinib (AG-013736) as Second Line Therapy for Metastatic Renal Cell Cancer: AXIS Trial

LEUKEMIA & LYMPHOMA / MDS

USO 07152: An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

USO 07-083: Phase I Study of Oral Darinaspirin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas

USO 07-168: A Prospective, Non-Interventional Multicenter Registry in Iron Overloaded Lower-Risk Myelodysplastic Patients

LUNG CANCER

USOR 09015: A Phase 2, Multicenter, Randomized Study of Two Different Dose Regimens of Eribulin Mesylate in Combination with Intermittent Erlotinib in Patients with Previously Treated, Advanced Non-Small Cell Lung Cancer

USO 08-044: Randomized, Open-Label, Phase 3 Study of Pemetrexed plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer

USO 06-135: Phase II Trial of Sunitinib Malate in Previously Untreated NSCLS Patients > 70

USO 06-206: A Multi-center Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-Positive Tumors

USO 06-026: A Multi-Center Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-Positive Tumors

MULTIPLE MYELOMA

USO 06-108: A Randomized Phase 3b 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) (UPFRONT)

PHASE I STUDIES/SOLID TUMORS

USO 09-167: An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the MEK Inhibitor GSK1120212 in Subjects with Solid Tumors (Colon, Pancreas, NSCLC, Melanoma) or Lymphoma

USO 08-210: A Phase 1 Dose-Escalation Study of LY2382770, a TGF-beta Monoclonal Antibody, in Patients with Metastatic Cancer

USO 05-033: A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT), Safety and Pharmacokinetics of CGC-11047 when used in individual combinations with Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib in patients with advanced solid tumors or lymphoma.

USO 08-008: A Phase 1b, Multicenter, Dose-Escalation Study of LY573636-sodium in Combination with 1) Gemcitabine HCI or 2)Docetaxel or 3) Temozolomide or 4) Cisplatin in Patients with Advanced Solid Tumors

USO 08-029: A Phase 1b Study of LY573636-sodium in Combination with Sunitinib Malate in Patients with Metastatic Renal Cell Cancer (JZAI)

USO 07-083: Phase I Study of Oral Darinaspirin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas

SARCOMA

No Active Studies

SUPPORTIVE CARE

USO 09-129: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Multi-National Study forth Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects with Symtomatic Deep-Vein Thrombosis and/or Pulmonary Embolism

CALGB 90201: A Randomized Double Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

TRANSPLANT/HIGH-DOSE

No Active Studies

SKIN