HSHS St. Vincent Hospital Regional Cancer Center Adult Active Study List

Transcription

1 E2905 ECOG NCT Blood Disorders-Other Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia INCYTE INCB- MA-PV-401 PERSIST-2 PACS326 PNH Registry M DRUG CO NCT Blood Disorders-Other Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices DRUG CO NCT Blood Disorders-Other A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis DRUG CO NCT Blood Disorders-Other PNH Registry A ALLIANCE NCT Brain A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation A ALLIANCE NCT Brain A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil ) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma E3F05 ECOG NCT Brain Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas R1205 RTOG NCT Brain Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma A ALLIANCE NCT Breast- Miscellaneous Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias B-51 NSABP NCT Breast- Miscellaneous A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy SCUSF 1102 SCUSF NCT Breast- Miscellaneous A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of GeneticsServices Among Breast Cancer Patients 12/21/2015 Page 1 of 7

2 ABI-007-MBC- 001 ACCRU NCT Breast-Advanced E2112 ECOG NCT Breast-Advanced Novartis CLEE011E2301 WON NCT Breast-Advanced R1119 RTOG NCT Breast-Advanced RU011201I ACCRU NCT Breast-Advanced A ALLIANCE NCT Breast-Early Stage B-55 NSABP NCT Breast-Early Stage BR003 NRG NCT Breast-Early Stage E1Z11 ECOG NCT Breast-Early Stage A Phase 2/3, Multi-center, Open-Label, Randomized Study of Weekly Nab -Paclitaxel in Combination with Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in subjects with ER, PgR, AND HER2 Negative (Triple Negative) Metastatic Breast Cancer A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer A Phase III Randomized, Double-blind, Placebocontrolled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2- negative, Advanced Breast Cancer Phase II Randomized Study of Whole Brain Radiotherapy in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of RTOG and KROG A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second- Line Therapy for Locally Recurrent or Metastatic Breast Cancer A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (ct1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy A Randomized, Double-blind, Parallel group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node- Negative Triple Negative Invasive Breast Cancer A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) 12/21/2015 Page 2 of 7

3 S1207 SWOG-L NCT Breast-Early Stage Z11102 ACSOG-L NCT Breast-Early Stage Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer.e3 Breast Cancer Study- evaluating everolimus with endocrine therapy. Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC) N0392 NCCTG Cancer Control-Other Assessment of Patient Satisfaction with Participation in Phase II/III NCCTG Clinical Trials URCC12107 URCC NCT Cancer Control-Other Evaluation of Psychoeducation for Cancer PatientsEligible for Clinical Trials URCC13059 URCC NCT Cancer Control-Other A Geriatric Assessment Intervention for PatientsAged 70 and Over Receiving Chemotherapy for Advanced Cancer: Reducing Chemotherapy Toxicity in Older Adults 0724 RTOG NCT Cervical Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy G0263 GOG NCT Cervical Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy E7208 ECOG NCT Colon and Rectal A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy GLNE010 ALLIANCE NCT Colon and Rectal Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma MPR-1 NSABP NCT Colon and Rectal NSABP Patient Registry and Biospecimen Profiling Repository RU021302I ACCRU NCT Colon and Rectal BOND-3: A Randomized, Double-blind, Placebo- Controlled Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared with Irinotecan, Cetuximab, and Placebo in RAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer RU021407I ACCRU NCT Colon and Rectal Regorafenib Dose Optimization Study (ReDOS); A Phase II Randomized Study of Lower Dose Regorafenib Compared to Standard Dose Regorafenib in Patients with Refractory Metastatic Colorectal Cancer (mcrc) 12/21/2015 Page 3 of 7

4 S0820 SWOG-L NCT Colon and Rectal A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) BBI ACCRU NCT GI Cancers- Miscellaneous A Phase III Randomized, Double-Blind, Placebo- Controlled Clinical Trial of BBI608 plus Weekly Paclitaxel vs. Placebo plus Weekly Paclitaxel in Adult Patients with Advanced, Previously Treated Gastric and Gastro-Esophageal Junction (GEJ) Adenocarcinoma 0912 RTOG NCT Head and Neck A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC )/Placebo, for the Treatment of Anaplastic Thyroid Cancer 0920 RTOG NCT Head and Neck A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally- Advanced Resected Head and Neck Cancer A ALLIANCE NCT Head and Neck A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy R1216 RTOG NCT Head and Neck Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck S0931 SWOG-L NCT Kidney (Renal) EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study E2906 ECOG NCT Leukemia-Acute Myelogenic Leukemia (AML) MDS/AML Registry A DRUG CO NCT Leukemia-Acute Myelogenic Leukemia (AML) ALLIANCE NCT Leukemia-Chronic Lymphocytic Leukemia (CLL) E1912 ECOG NCT Leukemia-Chronic Lymphocytic Leukemia (CLL) Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age > 60 Years) The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL) A Randomized Phase III Study of Ibrutinib (PCI )-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL) 12/21/2015 Page 4 of 7

5 9665 CALGB NCT Leukemia-Leukemia Specimen Banking Studies A A ALLIANCE NCT Lung- Non-Small Cell ALLIANCE NCT Lung- Non-Small Cell E4512 ECOG-A NCT Lung- Non-Small Cell R1306 RTOG NCT Lung- Non-Small Cell RC1126 ACCRU NCT Lung- Non-Small Cell CALGB NCT Lung- Small Cell Lung Cancer E1411 ECOG NCT Lymphoma-Non Hodgkin's E1412 ECOG NCT Lymphoma-Non Hodgkin's PIX306 DRUG CO NCT Lymphoma-Non Hodgkin's The CALGB Leukemia Tissue Bank Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) Adjuvant Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-small Cell : Crizotinib Versus Placebo for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non- Small Cell (NSCLC) A Randomized Phase II Trial of Erlotinib Alone or In Combination with Bevacizumab in Patients WithNon-Small Cell and Activating Epidermal Growth Factor Receptor Mutations Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin or Carboplatin and Etoposide Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV LR) Randomized Phase II Open Label Study of Lenalidomide R-CHOP(R2CHOP)vs RCHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell Non- Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant 12/21/2015 Page 5 of 7

6 A ALLIANCE NCT Melanoma Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma E2607 ECOG NCT Melanoma A Phase II Trial of Dasatinib in KIT-Positive Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas EA6134 ECOG-A NCT Melanoma A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma E1A11 ECOG NCT Multiple Myeloma Randomized Phase III Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma E3A06 ECOG NCT Multiple Myeloma Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma MM Registry QMR DRUG CO NCT Multiple Myeloma MM: The Multiple Myeloma Disease Registry S1211 SWOG-L NCT Multiple Myeloma A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC ) for Newly Diagnosed High Risk Multiple Myeloma (HRMM) S1304 SWOG-L NCT Multiple Myeloma A Phase II Randomized Study Comparing Two Doses of Carfilzomib(NSC ) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease 0213 GOG NCT Ovarian A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865, IND #113912) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum- Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #113912) G0225 GOG NCT Ovarian Can Diet and Physical Activity Modulate Ovarian or Primary Peritoneal Cancer Progression-Free Survival 0848 RTOG NCT Pancreas A Phase II-R and A Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (PhIII) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma 12/21/2015 Page 6 of 7

7 R1201 RTOG NCT Pancreas A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and nab-paclitaxel for Locally Advanced Pancreatic Cancer 0815 RTOG NCT Prostate A Phase III Prospective Randomized Trial of Dose- Escalated Radiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate-Risk Prostate Cancer 0924 RTOG NCT Prostate Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial A ALLIANCE NCT Prostate A Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer S1216 SWOG-L NCT Prostate A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer A ALLIANCE NCT Solid Tumor- Other Prospective Randomized Phase II Trial of Pazopanib (NSC # , IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors 0238 GOG NCT Uterine-Endometrial A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus G0286B GOG NCT Uterine-Endometrial A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer 12/21/2015 Page 7 of 7