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
MELANOMA
MULTIPLE MYELOMA
PHASE I TRIALS/SOLID TUMORS
SARCOMA
SUPPORTIVE CARE
TRANSPLANT/HIGH-DOSE
SKIN

BREAST

USO 10-065: A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination with Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer (E7389-A001-212)

USO 10-167: A Randomized, Phase 2 Trial of Preoperative MM-121 with Paclitaxel in HER2-negative Breast Cancer (MM-121-02-02-07)

NSABP B-47: 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

USO 08-223: A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Daily Everolimus in Combination with Trastuzumab and Vinorelbine, in Pretreated Women with HER2/neu Over-expressing Locally Advanced or Metastatic Breast Cancer

USO 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

USO 09-185: An Open-Label, Expanded Access Protocol of Iniparib in Combination with Gemcitabine/Carboplatin in Patients with ER-, PR-, and HER2-Negative Metastatic Breast Cancer

CALGB 40603: RANDOMIZED PHASE II 2X2 FACTORIAL TRIAL OF THE ADDITION OF CARBOPLATIN AND/OR BEVACIZUMAB TO NEOADJUVANT WEEKLY PACLITAXEL FOLLOWED BY DOSE-DENSE AC IN HORMONE RECEPTOR-POOR/HER2-NEGATIVE RESECTABLE BREAST CANCER

USO 08-201: A Randomized Double Blind Placebo-Controlled Trial of Neratinib (HKI-272) Following Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer (Wyeth 3144A2-3004-WW)

HOG BRE09-146: PARP Inhibition after Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer or ER/PR +, HER2 negative with known BRCA1/2 Mutations

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

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

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

GYN

USO 09-194: An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 in Subjects with Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy

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

GOG 262: 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 Bevacizumab (NSC #704865, IND #7921) in The Treatment of Primary Stage III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer

GASTROINTESTINAL

USO 11-072: Phase 1/2 Study of PX-866 and Cetuximab in Colorectal Cancer & Head & Neck Cancer (PX-866-003)

USO 08-095: A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination with Gemcitabine in Patients with Pancreatic Cancer (I2I-MC-JMMC)

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

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 10-278: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer (10TASQ10)

Johnson & Johnson Protocol 212082-PCR-3001: An Open Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy

USO 09-217: An Open-Label, Multicenter, Randomized Phase 2 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 First-line Platinum-based Therapy (IMCL CP20-0902)

USO 10-157: AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PHASE III STUDY TO COMPARE THE SAFETY AND EFFICACY OF TKI258 VERSUS SORAFENIB IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA AFTER FAILURE OF ANTI-ANGIOGENIC (VEGF-TARGETED AND MTOR INHIBITOR) THERAPIES

Teva Pharmaceutical Protocol OGX-011-11: A Ransdomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer

USO 10-164: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer

USO 10-165: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

USO 09-187: An Open-Label, Multicenter, Randomized Phase Ib/II Study of Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer (E7389-702)

Hoosier Oncology Group GU07-122: A Pilot Study of Neoadjuvant Dasatinib Followed by Radical Cystectomy for Transitional Cell Carcinoma of the Bladder

USO 10-111: A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of pazopanib as adjuvant therapy for subjects with localized or locally advanced RCC following nephrectomy

Medivation MDV3100-03 (PREVAIL): Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

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)

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

LEUKEMIA & LYMPHOMA / MDS

USO 10-270: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML) (AZA PH US 2007 CL 005)

USO 10-139: A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients with Relapsed or Refractory Multiple Myeloma

LUNG CANCER

CTSU E5508: 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 Non-Small Cell Lung Cancer (NSCLC)

MELANOMA

USOR 09142: A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma (111482)

USO 09-191: An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination with Dacarbazine versus Dacarbazine Alone as First Line Therapy in Patients with Stage IV Melanoma (E7080-702)

MULTIPLE MYELOMA

No Active Studies

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 10-190: A Phase 1 and Pharmacologic Study of MM-111 in Combination with Multiple Treatment Regimens in Patients with Advanced HER2 Positive Solid Tumors

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

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

USO 09-249: A Randomized, Blinded, Placebo-Controlled, Two-Phase, Sequential Cohort, Dose Finding Study to Assess the Safety and Efficacy of an Oral Thrombopoietin, Receptor Agonist, Eltrombopag (SB-497115-GR), Administered to Patients with Solid Tumors Receiving Gemcitabine Monotherapy or the combination of Gemcitabine Plus Carboplatin or Cisplatin (TRC112765)

SARCOMA

No Active Studies

SUPPORTIVE CARE

Duke Protocol 00011739: A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (PHACS)

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

No Active Studies