Cancer Center Cancer Center Trials at St. Trials at St.

Barnabas Medical Barnabas Medical CenterCenter

Oncology clinical research at Saint Oncology clinical research at Saint Barnabas Medical Center (SBMC) is Barnabas Medical Center (SBMC) is supported by a staff of three.supported by a staff of three.

The clinical research group manages The clinical research group manages the studies in the Cancer Center the studies in the Cancer Center (Medical Oncology) and The (Medical Oncology) and The Department of Radiation Oncology. Department of Radiation Oncology. In all, there are 12 physicians who In all, there are 12 physicians who make up this group of oncologists.make up this group of oncologists.

The SBMC was most recently The SBMC was most recently approved with commendation by the approved with commendation by the American College of Surgeons.American College of Surgeons.

Our goal is to accrue approximately Our goal is to accrue approximately 85 patients per year to clinical trials.85 patients per year to clinical trials.

Our physicians willingly refer Our physicians willingly refer patients to outside facilities for patients to outside facilities for clinical trials not offered at SBMC.clinical trials not offered at SBMC.

Most of the trials offered at SBMC Most of the trials offered at SBMC are treatment-based.are treatment-based.

Other types of trials include Other types of trials include observational and prevention observational and prevention studies.studies.

SBMC participates in clinical trials SBMC participates in clinical trials sponsored by several National Cancer sponsored by several National Cancer Institute cooperative groups and Institute cooperative groups and pharmaceutical companies.pharmaceutical companies.

SBMC is considered a member SBMC is considered a member accessible to trials from CALGB, NSABP, accessible to trials from CALGB, NSABP, and RTOG.and RTOG.

Our membership to CTSU allows for Our membership to CTSU allows for participation in a wide range of other participation in a wide range of other NCI cooperative group trials as well.NCI cooperative group trials as well.

SBMC is currently enrolling patients in SBMC is currently enrolling patients in studies for the following sites of studies for the following sites of disease:disease: Adjuvant and Metastatic Breast CancerAdjuvant and Metastatic Breast Cancer Primary and Metastatic Brain CancerPrimary and Metastatic Brain Cancer Adjuvant and Metastatic Gastrointestinal Adjuvant and Metastatic Gastrointestinal

CancerCancer Recurrent GYN CancerRecurrent GYN Cancer Adjuvant Genitourinary CancerAdjuvant Genitourinary Cancer Multiple MyelomaMultiple Myeloma

A complete listing of our studies can A complete listing of our studies can be found at be found at www.sbhcs.comwww.sbhcs.com..

Navigate to the Cancer Center at Navigate to the Cancer Center at Saint Barnabas Medical CenterSaint Barnabas Medical Center

Review of Cancer Center Review of Cancer Center

Open TrialsOpen Trials

ECOG E5103 A Double-Blind Phase III Trial of ECOG E5103 A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node with Lymph Node Positive and High Risk Lymph Node Negative Breast CancerNegative Breast Cancer

NSABP B-39 A Randomized Phase III Study of NSABP B-39 A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) forWomen with Stage Partial Breast Irradiation (PBI) forWomen with Stage 0, I, or II Breast Cancer0, I, or II Breast Cancer

IBCSG 24-02 A Phase III Trial Evaluating the Role of IBCSG 24-02 A Phase III Trial Evaluating the Role of Ovarian Suppression and the Role of Exemestane as Ovarian Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Adjuvant Therapies for Premenopausal Women with Endocrine Breast Cancer (SOFT)Endocrine Breast Cancer (SOFT)

SWOG S0307 Phase III Trial of Bisphosphonates SWOG S0307 Phase III Trial of Bisphosphonates ( Zoledronic acid Vs. Clodronate Vs. Ibandronate) as ( Zoledronic acid Vs. Clodronate Vs. Ibandronate) as Adjuvant Therapy for Primary Breast CancerAdjuvant Therapy for Primary Breast Cancer..

Breast Cancer Trials Stage Breast Cancer Trials Stage I, II, IIII, II, III

NSABP B-42 A Clinical Trial to Determine the Efficacy NSABP B-42 A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast CancerHormone Receptor Positive Breast Cancer

NCCTG N063D/ALTTO Adjuvant Lapatinib and/or NCCTG N063D/ALTTO Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study:  A Trastuzumab Treatment Optimization Study:  A randomized, multi-center, open-label, phase III study randomized, multi-center, open-label, phase III study of adjuvant Lapatinib, Trastuzumab, their sequence of adjuvant Lapatinib, Trastuzumab, their sequence and their combination in patients with HER2/ErbB2 and their combination in patients with HER2/ErbB2 positive primary breast cancer.positive primary breast cancer.

CALGB 369901 Observational Cohort Study: CALGB 369901 Observational Cohort Study: chemotherapy decisions and outcomes in women age chemotherapy decisions and outcomes in women age 65 or older with operable, newly diagnoses breast 65 or older with operable, newly diagnoses breast cancer.cancer.

WYETH 3144A2-3004 WW A Randomized Double-WYETH 3144A2-3004 WW A Randomized Double-Blind Placebo Controlled Trial of Neratinib (HKI-272) Blind Placebo Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast  2/neu Overexpressed/Amplified Breast  

  Breast Cancer Trials MetastaticBreast Cancer Trials Metastatic

CZOL446E2352 A prospective, randomized, stratified, CZOL446E2352 A prospective, randomized, stratified, placebo-controlled, multi-center, 2-arm trial of the continued placebo-controlled, multi-center, 2-arm trial of the continued efficacy and safety of Zometa (every 4 weeks vs. every 12 efficacy and safety of Zometa (every 4 weeks vs. every 12 weeks) in patients with documented bone metastases from weeks) in patients with documented bone metastases from breast cancer. breast cancer.

TOC4129g A Phase III, Randomized, Double-Blind, Placebo-TOC4129g A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer Positive Metastatic Breast Cancer

CALGB 40302 Endocrine Therapy With or Without Inhibition CALGB 40302 Endocrine Therapy With or Without Inhibition of EGF & HER2 Growth Factor Receptors: A Randomized, of EGF & HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatanib for Postmenopausal Fulvestrant with or without Lapatanib for Postmenopausal Women with ER &/or PR Positive Advanced Breast Cancer Women with ER &/or PR Positive Advanced Breast Cancer

Celsion A Phase I-II Study Evaluating the Maximum Tolerated Celsion A Phase I-II Study Evaluating the Maximum Tolerated Dose, Pharmacokinetics, Safety, and Efficacy of Microwave Dose, Pharmacokinetics, Safety, and Efficacy of Microwave Hyperthermia and Thermodox (Lyso-Thermosensitive Hyperthermia and Thermodox (Lyso-Thermosensitive Liposomal Doxorubicin) in Patients With Breast Cancer Liposomal Doxorubicin) in Patients With Breast Cancer Recurrence at the Chest WallRecurrence at the Chest Wall

  Multiple MyelomaMultiple Myeloma

C05009 Randomized Phase III study of 3 C05009 Randomized Phase III study of 3 Novel treatment regimens in subjects Novel treatment regimens in subjects with previously untreated multiple with previously untreated multiple myeloma who are not considered myeloma who are not considered candidates for high dose chemotherapy candidates for high dose chemotherapy and autologous stem cell and autologous stem cell transplantation: Velcade (Bortezomib), transplantation: Velcade (Bortezomib), Thalomid (Thalidomide), and Thalomid (Thalidomide), and Dexamethasone (VTD) vs. Velcade and Dexamethasone (VTD) vs. Velcade and Dexamethasone (VD) vs. Velcade, Dexamethasone (VD) vs. Velcade, Melphalan, and Prednisone (VMP) Melphalan, and Prednisone (VMP) 

Gastrointestinal, MetastaticGastrointestinal, Metastatic

SWOG S0600 Phase III Trial of SWOG S0600 Phase III Trial of Irinotecan-Based Chemotherapy Plus Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) As Bevacizumab (NSC-704865) As Second-Line Therapy For Patients With Second-Line Therapy For Patients With Metastatic Colorectal Cancer Who Metastatic Colorectal Cancer Who Have Progressed on Bevacizumab with Have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX, XELOXEither FOLFOX, OPTIMOX, XELOX

Gastrointestinal STAGE I, II, IIIGastrointestinal STAGE I, II, III

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

GenitourinaryGenitourinary

ECOG E2805 A Randomized, Double-ECOG E2805 A Randomized, Double-Blind Phase III Trial of Adjuvant Blind Phase III Trial of Adjuvant Sunitinib vs Sorafenib vs Placebo in Sunitinib vs Sorafenib vs Placebo in Patients with Resected Renal Cell Patients with Resected Renal Cell Carcinoma Carcinoma 

Brain, AdjuvantBrain, Adjuvant

RTOG 0825 Phase III Double-Blind RTOG 0825 Phase III Double-Blind Placebo-Controlled Trial of Conventional Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab vs. Temozolomide Plus Bevacizumab vs. Conventional Concurrent Chemoradiation Conventional Concurrent Chemoradiation and Adjuvant Temozolomide In Patients and Adjuvant Temozolomide In Patients with Newly Diagnosed Glioblastomawith Newly Diagnosed Glioblastoma

Brain, MetastaticBrain, Metastatic

RTOG 0614 A Randomized Phase III RTOG 0614 A Randomized Phase III Double-Blind Placebo Controlled Trial of Double-Blind Placebo Controlled Trial of Memantine for Prevention of Cognitive Memantine for Prevention of Cognitive Dysfunction in Patients receiving Whole Dysfunction in Patients receiving Whole Brain Radiotherapy Brain Radiotherapy 

Gynecological Cancers,Gynecological Cancers,  Ovarian Ovarian

AVF4095g A Phase III, AVF4095g A Phase III, Multicenter, Randomized, Blinded, Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Placebo-Controlled Trial of Carboplatin and Gemcitabine Plus Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Bevacizumab in Patients With Platinum-Sensitive Recurrent Platinum-Sensitive Recurrent Ovary, Primary Peritoneal or Ovary, Primary Peritoneal or Fallopian Tube Carcinoma  Fallopian Tube Carcinoma  

Upcoming trialUpcoming trial

Collaboration with Genomic Collaboration with Genomic Health for participation in a Health for participation in a Registry Study for Oncotype DX Registry Study for Oncotype DX in Breast Cancer in the Neo-in Breast Cancer in the Neo-adjuvant and Adjuvant settingadjuvant and Adjuvant setting

For more information on For more information on any of our studies contact:any of our studies contact:

Elyce Hirtler, Elyce Hirtler, Research Manager Research Manager

973-322-2527973-322-2527ehirtler@sbhcs.comehirtler@sbhcs.com