Transcript Cancer Center Trials at St. Barnabas Medical Center

Cancer Center Trials at
St. Barnabas Medical
Center
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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.
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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.
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Most of the trials offered at SBMC are
treatment-based.
Other types of trials include observational and
prevention studies.
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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.
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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
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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
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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
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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
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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)
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SWOG S0307 Phase III Trial of Bisphosphonates ( Zoledronic acid Vs.
Clodronate Vs. Ibandronate) as Adjuvant Therapy for Primary Breast
Cancer.
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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
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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.
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CALGB 369901 Observational Cohort Study: chemotherapy
decisions and outcomes in women age 65 or older with operable,
newly diagnoses breast cancer.
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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
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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.
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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
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CALGB 40302 Endocrine Therapy With or Without Inhibition of EGF &
HER2 Growth Factor Receptors: A Randomized, Double-Blind, PlaceboControlled Phase III Trial of Fulvestrant with or without Lapatanib for
Postmenopausal Women with ER &/or PR Positive Advanced Breast
Cancer
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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
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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
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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
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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
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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
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RTOG 0825 Phase III Double-Blind PlaceboControlled 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
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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
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AVF4095g A Phase III, Multicenter,
Randomized, Blinded, PlaceboControlled 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
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For more information on any of our
studies contact:
Elyce Hirtler,
Research Manager
973-322-2527
[email protected]