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Protocols

The Alvin and Lois Lapidus Cancer Institute
Oncology Protocol Refernce
February 2009

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Breast Cancer

BO 20289 BEATRICE: An International Multi-Centre Open -Label 2- Arm Phase III Trial of Adjuvant Bevacizumab in Triple Negative Breast Cancer  PI: Cristina Truica, MD

The TAILORx Trial (PACCT-1): Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment  PI: Cristina Truica, MD

SWOG 0221: Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High- Risk Node Negative Breast Cancer  PI: Cristina Truica, MD

SWOG 0307: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer  PI: Cristina Truica, MD

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 Brest Cancer  PI: Cristina Truica, MD

SWOG S0622: Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer  PI: Cristina Truica, MD

CALGB 40101: Cyclophosphamide and Doxorubicin (CA x 4 Cycles) Versus Paclitaxel (4 Cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A Phase III Randomized Study
PI: Cristina Truica, MD

 

Neoadjuvant Hormonal Therapy

ACOSOG Z1031: A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg daily), Letrozole (2.5mg), or Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II And III Estrogen Receptor Positive Breast Cancer  PI: Cristina Truica, MD

 

Metastatic Breast Cancer

SWOG S0500: A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-up Assessment  PI: Cristina Truica, MD

 

Supportive Care - Breast CA

SWOG S0715: Randomized Placebo-Controlled Trial of Acetyl L-Carnitine for the Prevention of Taxane Induced Neuropathy  PI: Cristina Truica, MD

 

Ovarian

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: Pallavi Kumar, MD

 

Melanoma

SWOG E1697: Phase III Randomized Study of Four Weeks High Dose IFN-?2b in Stage T3-T4 or N1 (Microscopic) Melanoma  PI: Mukund Didolkar, MD

 

Lymphoma

 

Follicular

PALO-08-09: Multicenter, Phase IV, Open-Label, Uncontrolled Study to Assess the Efficacy and Safety of a Single Intravenous Dose of Palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin's Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy   PI: Stephen J. Noga, MD

U4391g: A Phase III Multicenter, Open-label Study of rituximab Faster Infusion Time in Patients with Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma   PI: Stephen J. Noga, MD

SWOG S0801: A Phase II Study of Iodine-131 Labeled Tositumomab in Combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma  PI: Stephen J. Noga, MD

 

Diffuse Large B-Cell

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: Stephen Noga, MD

U4391g: A Phase III Multicenter, Open-Label Study of Rituximab Faster Infusion Time in Patients with Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma  PI: Stephen Noga, MD

C05013: 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: Stephen J. Noga, MD

PALO-08-09: Multicenter, Phase IV, Open-Label, Uncontrolled Study to Assess the Efficacy and Safety of a Single Intravenous Dose of Palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin's Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy  PI: Stephen J. Noga, MD

 

Mantle Cell

26866138-LYM-3002: A Randomized, Open-Label, Multicentre Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone(R-CHOP) in Patients with Newly Diagnosed Mantle Cell Lymphoma who are not Eligible for Bone Marrow Transplant  PI: Stephen Noga, MD

CC-5013-MCL-001: The EMERGE Trial" A Phase 2, Multicenter, Single-Arm, Open Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide REVLIMID in Patients with Mantle Cell NHL Who Have Relapsed or Progressed After Treatment with Bortezomib or are Refractory to Bortezomib PI: Stephen Noga, MD

 

Multiple Myeloma

AVF4064g: A Randomized, Blinded, Placebo-Controlled, Phase II Study of Bevacizumab in Combination with Bortezomib Compared with Bortezomib in Patients with Relapsed or Refractory Multiple Myeloma  PI: Stephen Noga MD

C18083 / 1063 / MM/US: An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma  PI: Stephen J. Noga, MD

HGT-GCB-058: A Multicenter Open-Label Treatment Protocol to Observe the Safety of  Gene-Activated® Human Glucocerebrosidase (GA-GCB,velaglucerase alfa) Enzyme Replacement Therapy in Newly Diagnosed or Previously Treated (with imiglucerase) Patients with Type 1 Gaucher Disease  PI: Stephen J. Noga, MD

S0777, "A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant"  PI: Stephen J. Noga, MD

 

Lung Cancer

CASA404A2301: A Phase III, Randomized, Double- Blind, Placebo Controlled Multi-center of ASA404 in Combination with Paclitaxel and Carboplatin as First Line Treatment for Locally Advanced or Metastatic (Stage III b /IV) Non -Small Cell Lung Cancer PI: 

ACCL001.0: A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non -Small Cell Cancer.  PI: Lynn Skaryak, MD 

AC01L08: A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination with Platinum-Based Chemotherapy as First Line Treatment of Patients with Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)  PI: Stephen J. Noga, MD

NSCLC: A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients with Advanced Non-Small Cell Lung Cancer  PI: Stephen J. Noga, MD

SCLC

AMR PH GL 2007 CL 001 Celgene: A Randomized , Open - Label, Multinational Phase 3 Trial Comparing Amrubicin versus Topotecan in Patients with Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First Line Chemotherapy PI:

 

Colon Cancer

AMGEN SPIRITT 20060141: A Multi-Center, Open label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI with either Panitumumab or Bevacizumab as Second Line treatment in Subjects with metastatic Colorectal Cancer PI:

E5202: A Randomized Phase III Study Comparing 5-FU, 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 PI: 

Amgen 20080259:  A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)  PI: Lavanya Yarlagadda, MD

 

Renal Cell

The BeST Trial: A Randomized Phase II Study of VEGF, RAF kinase, and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma
PI: Stephen Noga, MD

 

Pancreatic

SWOG S0727: "A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First-Line Treatment in Patients with Metastatic Pancreatic Cancer"  PI: Stephen J. Noga, MD

 

Prostate

ACCP001.0: Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution PI:

Supportive Care

EFC6521: A Multinational, Randomized, Double-Blind ,Placebo Controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism ( VTE) in Cancer Patients at High Risk for VTE and Who are Undergoing Chemotherapy  PI: Stephen Noga, MD

MDA 2006-0841: A Randomized, Double- Blind, Placebo - Controlled Trail of Palonosetron/ Dexamethasone with or without Dronabinol for Prevention of Chemotherapy -induced Nausea and Vomiting after Moderately Emetogenic Chemotherapy  PI: Stephen Noga, MD

MDA 2007-0791: A Randomized Comparison of Oral Methadone as a "First Switch" Opioid versus Opioid switching between sustained-release Morphine and Oxycodone for Oncology-Hematology Outpatients with Pain Management Problems: The "Simply Rotate" Study  PI: Stephen J. Noga, MD

SWOG S0622: Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastic Breast Cancer  PI: Cristina Truica, MD

SWOG 0307: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer  PI: Cristina Truica, MD

Amgen 20080259: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)  PI: Lavanya Yarlagadda, MD

SWOG S0715: Randomized Placebo-Controlled Trial of Acetyl L-Carnitine for the Prevention of Taxane Induced Neuropathy  PI: Cristina Truica, MD

PALO-08-09:  Multicenter, Phase IV, Open-Label, Uncontrolled Study to Assess the Efficacy and Safety of a Single Intravenous Dose of Palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin's Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy  PI: Stephen J. Noga, MD

 

Imaging and Tissue Studies

The Use of Microarray in Characterizing Mesenchymal Tumors: Differentiation of Normal, Benign, and Malignant Conditions  PI: Albert Aboulafia, MD

2005LS080: An Evaluation of PET/CT Imaging As A Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy For Soft Tissue Sarcoma  PI: Albert Aboulafia, MD 

SWOG 9910: Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary  PI: Stephen Noga, MD

SWOG 9007: Cytogenetic Studies in Leukemia Patients  PI: Stephen Noga, MD

Comparing CT Based Structural Ridgidity Analysis (SRA) to Current Clinical and Radiological methods for Selecting Treatment Options for patients with Skeletal Metastasis  PI: Albert Aboulafia, MD

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The Alvin and Lois Lapidus Cancer Institute
2401 West Belvedere Avenue
Baltimore, Maryland 21215
Phone: 410- 601- 6120
Fax: 410- 601- 4714

Oncology Research Team:

Stephen Noga, M.D. PhD Director of Hematology and Oncology

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

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