Oncology clinical research at Saint Barnabas Medical Center (SBMC) is supported by a staff of three. • The clinical research group manages the studies in the Cancer Center (Medical Oncology) and The Department of Radiation Oncology. In all, there are 12 physicians who make up this group of oncologists.
The SBMC was most recently approved with commendation by the American College of Surgeons. • Our goal is to accrue approximately 85 patients per year to clinical trials. • Our physicians willingly refer patients to outside facilities for clinical trials not offered at SBMC.
Most of the trials offered at SBMC are treatment-based. • Other types of trials include observational and prevention studies.
SBMC participates in clinical trials sponsored by several National Cancer Institute cooperative groups and pharmaceutical companies. • SBMC is considered a member accessible to trials from CALGB, NSABP, and RTOG. • Our membership to CTSU allows for participation in a wide range of other NCI cooperative group trials as well.
SBMC is currently enrolling patients in studies for the following sites of disease: • Adjuvant and Metastatic Breast Cancer • Primary and Metastatic Brain Cancer • Adjuvant and Metastatic Gastrointestinal Cancer • Recurrent GYN Cancer • Adjuvant Genitourinary Cancer • Multiple Myeloma
A complete listing of our studies can be found at www.sbhcs.com. • Navigate to the Cancer Center at Saint Barnabas Medical Center
Review of Cancer Center Open Trials
Breast Cancer Trials Stage I, II, III • ECOG E5103 A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer • NSABP B-39 A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) forWomen with Stage 0, I, or II Breast Cancer • IBCSG 24-02 A Phase III Trial Evaluating the Role of Ovarian Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Breast Cancer (SOFT) • SWOG S0307 Phase III Trial of Bisphosphonates ( Zoledronic acid Vs. Clodronate Vs. Ibandronate) as Adjuvant Therapy for Primary Breast Cancer.
NSABP B-42 A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer • NCCTG N063D/ALTTO Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study: A randomized, multi-center, open-label, phase III study of adjuvant Lapatinib, Trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer. • CALGB 369901 Observational Cohort Study: chemotherapy decisions and outcomes in women age 65 or older with operable, newly diagnoses breast cancer. • WYETH 3144A2-3004 WW A Randomized Double-Blind Placebo Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast
Breast Cancer Trials Metastatic • CZOL446E2352 A prospective, randomized, stratified, placebo-controlled, multi-center, 2-arm trial of the continued efficacy and safety of Zometa (every 4 weeks vs. every 12 weeks) in patients with documented bone metastases from breast cancer. • TOC4129g A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer • CALGB 40302 Endocrine Therapy With or Without Inhibition of EGF & HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatanib for Postmenopausal Women with ER &/or PR Positive Advanced Breast Cancer • Celsion A Phase I-II Study Evaluating the Maximum Tolerated Dose, Pharmacokinetics, Safety, and Efficacy of Microwave Hyperthermia and Thermodox (Lyso-Thermosensitive Liposomal Doxorubicin) in Patients With Breast Cancer Recurrence at the Chest Wall
Multiple Myeloma • C05009 Randomized Phase III study of 3 Novel 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), Thalomid (Thalidomide), and Dexamethasone (VTD) vs. Velcade and Dexamethasone (VD) vs. Velcade, Melphalan, and Prednisone (VMP)
Gastrointestinal, Metastatic • SWOG S0600 Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) As Second-Line Therapy For Patients With Metastatic Colorectal Cancer Who Have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX, XELOX
Gastrointestinal STAGE I, II, III • ECOG E5202 A Randomized Phase III Study Comparing 5FU, 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
Genitourinary • ECOG E2805 A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib vs Sorafenib vs Placebo in Patients with Resected Renal Cell Carcinoma
Brain, Adjuvant • RTOG 0825 Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab vs. Conventional Concurrent Chemoradiation and Adjuvant Temozolomide In Patients with Newly Diagnosed Glioblastoma Brain, Metastatic • RTOG 0614 A Randomized Phase III Double-Blind Placebo Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients receiving Whole Brain Radiotherapy
Gynecological Cancers,Ovarian • AVF4095g A Phase III, Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-Sensitive Recurrent Ovary, Primary Peritoneal or Fallopian Tube Carcinoma
Upcoming trial • Collaboration with Genomic Health for participation in a Registry Study for Oncotype DX in Breast Cancer in the Neo-adjuvant and Adjuvant setting
For more information on any of our studies contact:Elyce Hirtler, Research Manager firstname.lastname@example.org