The Alvin & Lois Lapidus Cancer Institute
Oncology Protocol Reference
Please refer to the LifeBridge Health Active Clinical Trials Listing for additional information.
Breast Cancer
NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2 positive DCIS resected by Lumpectomy
PI: Mayer Gorbaty, M.D.
S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less.
PI: Mukund Didolkar, M.D.
SCUSF 0806: Phase II Placebo-Controlled Trial of Lisinopril and Coreg CR® to reduce cardiotoxicity in Patients with Breast Cancer Receiving (neo) Adjuvant Chemotherapy with trastuzumab (Herceptin®).
PI: Mayer Gorbaty, M.D.
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
PI: Mayer Gorbaty, M.D.
PROMIS: Prospective Registry of MammaPrint in breast cancer patients with an Intermediate recurrence Score
PI: Mayer Gorbaty, M.D.
Amgen 20110147: Randomized, phase 2 study to estimate the effect of prophylactic intervention with naproxen or loratadine on bone pain in breast cancer subjects receiving chemotherapy and pegfilgrastim
PI: Mayer Gorbaty, M.D.
Metastatic Breast Cancer
E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer.
PI: Mayer Gorbaty, M.D.
N093B: Phase I/II Study of Panobinostat (LBH589) and Letrozole in Patients with Triple Negative Metastatic Breast Cancer
PI: Mayer Gorbaty, M.D. ***Temporarily Closed***
AV-951-12-204: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 2-arm, Multicenter Study Comparing Tivozanib Hydrochloride in Combination with Paclitaxel Versus Placebo in Combination with Paclitaxel in the Treatment of Subjects with Locally Recurrent and/or Metastatic Triple Negative Breast Cancer
PI: Mayer Gorbaty, M.D.
Gynecological Cancer
ChemoFX Observational Study: A Non-Interventional, Longitudinal, Multi-Center Initiative Examining Outcomes Associated with the Use of the ChemoFx Assay in Solid Tumor Malignancies.
PI: Fouad Abbas, M.D.
Uterine
GOG-0238: A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine
Corpus. PI: Fouad Abbas, M.D.
Uterine (Carcinosarcoma)
GOG-0261: A Randomized Phase III Trial of Paclitaxel Plus Carboplatin versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus.
PI: Fouad Abbas, M.D.
GOG 0130F: A Phase II Evaluation of Ixabepilone in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus. PI: Mark Miller, D.O.
Ovarian
GOG-0170Q: A Phase II Evaluation of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) in the Treatment of Persistent or Recurrent Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer.
PI: Fouad Abbas, M.D. ***Temporarily Closed, May Re-opn***
GOG-0186I: A Randomized Phase II Evaluation of Single-Agent Bevacizumab (IND #7921) (NSC #704865) And
Combination Bevacizumab with Fosbretabulin Tromethamine (CA4P) (NSC #752293) In the Treatment of Recurrent or
Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
PI: Mark Miller, D.O.
GOG 0264: A Randomized Phase II Trial of Paclitaxel and Carboplatin VS. Bleomycin, Etoposide and Cisplatin for Newly
Diagnosed Advanced Stage and Recurrent Chemonaive Stage Sex Cord-Stromal Tumors of the Ovary
PI: Mark Miller, D.O.
GOG-0186J: A Randomized Phase IIB Evaluation of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754) Versus Weekly Paclitaxel Plus Placebo In The Treatment Of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma
PI: Mark Miller, D.O.
EC-FV-06: A Randomized Double Blind Phase 3 Trial comparing EC145 and Pegylated Liposomal Doxorubicin( PLD) in Combination vs. PLD in participants with Platinum – Resistant Ovarian Cancer.
PI: Mark Miller, D.O.
Amgen TRINOVA-3 - 20101129/ENGOT-ov2/GOG-3001: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
PI: Mark Miller, M.D.
Endometrial
GOG-0258: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma.
PI: Fouad Abbas, M.D.
Lung Cancer
NSCLC
ACCL001.0: A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non –Small Cell Cancer.
PI: Jeanette Linder, MD
SWOG S0819: A Randomized, Phase II Study Comparing Carboplatin/Paclitaxel or Carboplatin/ Paclitaxel/Bevacizumab with or without Cetuximab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC).
PI: Roberto Martinez, M.D.
ECOG 1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>4 cm) – IIIA Non-Small Cell Lung Cancer (NSCLC).
PI: Roberto Martinez, M.D.
CALGB 30801: A Randomized Phase III Double Blind Trial Evaluating Selective COSX-2 Inhibition in COS-2 Expressing Advanced Non-Small Cell Lung Cancer.
PI: Roberto Martinez, M.D.
ECOG 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 NSCLC
PI: Roberto Martinez
Amgen Protocol 20070782: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects with Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy
PI: Roberto Martinez, M.D.
SCLC
CALGB 30610: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide.
PI: Roberto Martinez, M.D.
Gastrointestinal Cancers
Colon
CALGB/SWOG C80702: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib Or Placebo for
Patients with Resected Stage III Colon Cancer
PI: Mayer Gorbaty, M.D.
Gastric/GE Junction
SWOG S1005: A Phase II Study of MK-2206 as Second Line Therapy For Advanced Gastric and Gastroesophageal Junction Cancer. PI: Mayer Gorbaty M.D.
***Closing 05/01/2013***
GIST
ABO4030: a Prospective, Multicenter, Randomized, Open-Label, Active Controlled, 2-Parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib At 7,5 mg/kg/day to Imatinib at 400 or 600 mg in Treatment of Patients with Gastro-Intestinal Stromal Tumor in First Line Medical Treatment.
PI: Mukund Didolkar, MD
Pancreatic
ACOSOG Z5041: A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Adenocarcinoma
PI: Mukund Didolkar, M.D.
RTOG 0848: A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma.
PI: Mayer Gorbaty, M.D.
Prostate
ACCP001.0: Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution.
PI: Jeanette Linder, M.D.
Liver
CALGB 80802: Phase III randomized study of sorafenib (IND 69896, NSC 724772) plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC)
PI: Mayer Gorbaty
Orthopedic Oncology
Comparing CT-Based Structural Rigidity Analysis (SRA) to Current Clinical and Radiological Methods for Selecting Treatment Options for Patients with Skeletal Metastasis
PI: Albert Aboulafia, M.D.
The Use of Microarray in Characterizing Mesenchymal Tumors: Differentiation of Normal, Benign, and Malignant Conditions.
PI: Albert Aboulafia, M.D.
ET743-SAR-3007: A Randomized Controlled Study of YONDELIS® (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
PI: Albert Aboulafia, M.D.
Lymphoma
Diffuse Large B-Cell
CO5013: An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Patients with Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma.
PI: Joseph Wiley, M.D.
CALGB 50303: “Phase III Randomized Study of R-CHOP versus Dose- Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas.
PI: Roberto Martinez, M.D.
Follicular Lymphoma
CALGB 50904: A Randomized Phase II Trial of Ofatumumab and Bendamustine vs. Ofatumumab, Bortezomib and Bendamustine in Patients with Untreated Follicular Lymphoma
PI: Roberto Martinez, M.D.
CLL
PCI-32765CLL3001: Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine
Kinase (BTK) Inhibitor, in Combination with Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (The “HELIOS” trial)
PI: Roberto Martinez, M.D.
Melanoma
ECOG E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α-2b for Resected High-risk Melanoma
PI: Mukund Didolkar, M.D.
Supportive Care
MDA 2007-0914A (PREDICT): A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment.
PI: Joseph Wiley, M.D.
****Temporarily Closed***
Shire Gaucher Disease Outcome Survey (GOS)
Using data collected to better understand the course of the disease, how it is treated and possibly improve how patients are cared for.
PI: Joseph Wiley, M.D.
Survivorship Care Study: A Study of the Impact of Survivorship Care by Medical and Radiation Oncology Nurses for Cancer Survivors during the End of Active Treatment
PI: Kenneth Miller, M.D.
TCREG-001-00-V2-1209: “A Registry of Caris Target Now™ Test Results (Biomarker Expression Patterns) and Hematopoietic Diagnostics for Evaluation of Correlation with Clinical Outcomes for Cancer and Other Patients.”
PI: Fouad Abbas, M.D.
CPS-3: Cancer Prevention Study-3 (American Cancer Society)
PI: Kenneth Miller, M.D.
Oncology Research Team:
Judy Bosley, BSN, RN Clinical Research Manager
410-610-4393;
jbosley@lifebridgehealth.org
Pam Nickoles, BSN, RN Clinical Research Nurse
410-601-0729;
pnickole@lifebridgehealth.org
Paulette Ridgely, RN Clinical Research Nurse
410-601-4393;
pridgely@lifebridgehealth.org
Rose Bonvegna, Clinical Research Coordinator
410-601-6120;
rbonvegn@lifebridgehealth.org
Melissa Hagy, Clinical Research Associate
410-601-9083;
mhagy@lifebridgehealth.org
Back to the Top