Acute Coronary Syndrome
ACUITY: Comparison of Angiomax with or without upfront GPIIa/IIIb versus Enoxaparin with or without GPIIb/IIa for non ST-segment elevation.
Asthma
EXCELS: Evaluating clinical effectiveness and long-term safety in patients with moderate to severe asthma.
Atrial Fibrillation
ACTIVE: Comparing aspirin and Clopidogrel to aspirin alone for the prevention of vascular events and addition of Irbesartan versus placebo for further prevention.
CAD
CETP: To demonstrate whether or not the fixed combination torcetrapib/atorvastatin, compared to atorvastatin alone, can incrementally reduce the risk for future occurrence of major cardiovascular disease events, when compared to atorvastatin alone, in subjects with coronary heart disease or risk equivalents. Enrollment should end mid-September.
Carotid Stent
CAPTURE: Post-approved registry utilizing the FDA-approved ACCULINK/ACCUNET Carotid Stent System for patients at high risk for surgical intervention. Patients with "Symptomatic" >= 50% and <= 70% stenosis and patients with "Asymptomatic" >= 80% are eligible for this study.
Congestive Heart Failure and Ventricular Tachycardia
PEGASUS: To assess the effect of a CRT-D device programmed with atrial support pacing on a clinical composite score consisting of four components (death, heart failure events, NYHA class, global assessment tool).
RESPONSE HF: To evaluate the benefit of V-V delay optimization in reducing the non-responder rate in patients with CRT-D devices.
Distal Protection
AMETHYST: Percutaneous coronary intervention treatment of SVG with Interceptorä Coronary Filter System versus GuardWire.
Dye Interventional CT
VISIPAQUE DXV406: To compare the renal effects of the non-ionic iso-osmolar contrast medium, iodixanol, with the non-ionic low-osmolar contrast medium, iopamidol, in subjects with impaired renal function and diabetes undergoing multidetector-row helical CT.
Osteoporosis
DANCE: Evaluate the occurrence of non-vertebral fragility fractures in subjects treated with FORTEO for up to 24 months.
Pacemaker Device
ASSERT: History of HTN requiring pharmacological therapy (>4 weeks of therapy), age 65 years old, and primary indication for pacing is sinus or AV Node disease. No history of afib.
AWARE: To evaluate the incidence of AT/AF and inappropriate detection of AT/AF events in patients with a history of AT or AF.
HOUSECALL: To evaluate the Housecall Plus Remote Monitoring System in diagnosing the efficacy of device therapy and its impact on cost effectiveness.
RESPECT: Evaluation of AT500 Pacemaker Device on symptomatic AT/AF episode frequency in patients with septal trial lead placement.
RIGHT: To assess the efficacy of Guidant’s ICDs using Rhythm IDä vs. Medtronic ICDs with Enhanced PR Logicä or Waveletä.
SAVE PACe: To compare the percentage of ventricular pacing at one month post-implant in patients with SEARCH AVä EXTENDED and SEARCH AVä OFF.
Primary Prevention Trial
JUPITER: Males 55 years old and females 65 years old with no prior CAD, found to have LDL-C levels <130 mg/dL and CRP levels 2.0 mg/L. Treatment with Rosuvastatin 20 mg compared to placebo.
Stent
ENDEAVOR IV: A controlled trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions with a return for 8-month angiography.
Stroke
SAINT II: To assess the efficacy and safety of NXY-059 neuroprotectant in acute ischemic stroke.
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BREAST
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SOFT
(IBCSG24-02/BIG 2-02)
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Suppression of Ovarian Function Trial. A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer Tamoxifen versus Ovarian Function Suppression + Tamoxifen versus Ovarian Function Suppression + Exemestane.
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NSABP
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A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil (5-FU), Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node-Negative Breast Cancer
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B-36
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B-38
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A Phase III adjuvant trial comparing three chemotherapy regimens in women with node-positive breast cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); dose-dense (DD) Doxorubicin/Cyclophosphamide followed by DD Paclitaxel (DD AC→P); DD AC followed by DD Paclitaxel plus Gemcitabine (DD AC→PG)
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B-39
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A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, or II breast cancer
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SWOG S0307
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Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
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BRE 63
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A Phase II Trial of Combination Gemcitabine Carboplatin with or without Trastuzumab in Patients with Metastatic Breast Cancer
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NCIC CTG
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A Randomized Phase III Trial of Exemestane versus Anastrozole in Postmenopausal Women with Receptor-Positive Primary Breast Cancer
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MA 27
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Perifosine 208
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A Phase II Trial of Two Schedules of Perifosine in Combination with Endocrine Therapy for Patients with Estrogen Receptor or Progesterone Receptor Positive Metastatic Breast Cancer
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BRE 73
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Phase II Trial of Dose Dense Neoadjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced and/or Inflammatory Breast Cancer
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BRE 89
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Phase II Trial of Vinflunine with or without Trastuzumab in Patients with Metastatic Breast Cancer
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GE JUNCTION
AND STOMACH
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GIST
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Gastrointestinal Stromal Tumors (GIST) Registry Protocol
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SWOG S0414
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Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
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SWOG S0356
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Oxaliplatin plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
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CALGB
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A Phase III Trial of Adjuvant Chemoradiation after Resection of Gastric and Gastroesophageal Adenocarcinoma
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80101
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COLORECTAL
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NSABP R-04
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A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum
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MACCO-A
(MCC 13449)
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Microarray analysis of colon cancer outcome-A
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C-08
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A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks with Bevacizumab to the Same Regimen without Bevacizumab for the Treatment of Patients with Resected Stages II and III Carcinoma of the Colon
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GI 65
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Phase II Study of 5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in the Adjuvant Treatment of Patients with Stage II/III Rectal Cancer
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XELOX Colorectal
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"XELOX – A-DVS" (Dense vs. Standard): A Randomized Study of Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q3W) and Bevacizumab versus Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q2W) and Bevacizumab as First-Line Treatment for Patients with Metastatic Colorectal Cancer
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GENITOURINARY
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CALGB
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A Randomized, double-blind, placebo-controlled phase III study of early versus standard Zoledronic acid to prevent skeletal related events in men with prostate cancer metastatic to bone
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90202
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Perifosine 215
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A Placebo-Controlled, Double-Blind Trial of Perifosine in Combination with Docetaxel and Prednisone for Patients with Metastatic Androgen Independent Prostate Cancer
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HEMATOLOGICAL
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ECO-1
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A Phase II study using Alemtuzumab combined with Fludarabine for the treatment of B-cell chronic lymphocytic leukemia (B-CLL)
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LymphoCare
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An Observational Study of Treatment, Outcomes and Prognosis in Patients with Follicular Non-Hodgkin’s Lymphoma
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LYM 28
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Phase II Trial of Brief Duration Combination Chemotherapy (CNOP or CVP) and Rituximab with Prophylactic Pegfilgrastim (Neulasta), Followed by Maintenance Rituximab in Elderly/Poor Performance Status Patients with Large B-Cell Non-Hodgkin’s Lymphoma
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PIX 301
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Pixantrone (BBR 2778) versus other chemotherapeutic agents for third-line single agent treatment of patients with relapsed aggressive NHL: A randomized, controlled, phase III comparative trial
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SWOG S0106
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A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg) Induction Therapy versus Standard Induction with Daunomycin and Cytosine Arabinoside followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy with Gemtuzumab Ozogamicin (Mylotarg) or No Additional Therapy for Patients under Age 56 with Previously Untreated deNovo Acute Myeloid Leukemia (AML)
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SWOG S0016
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A Phase III Trial of CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin’s Lymphomas
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SWOG S0313
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Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin’s Lymphoma, Phase II
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DACO-016
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Randomized Phase 3 Trial of Decitabine versus Patient’s Choice with Physician’s Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients with Newly Diagnosed Acute Myeloid Leukemia
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MELANOMA
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Luitpold
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Phase III study of Taxoprexin injection versus Dacarbazine in patients with metastatic malignant melanoma
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LUNG
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RTOG 0412/
SWOG S0332
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Phase III Randomized Trial of Preoperative Chemotherapy versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients with Stage IIIA (N2) Non-Small Cell Lung Cancer
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OSI3364g Tarceva
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A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with TarcevaÔ (Erlotinib) Compared with Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) after Failure of Standard First-Line Chemotherapy
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Perifosine 201
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A Phase I/II Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
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Bayer 11961
(Sorafenib)
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A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib (BAY 43-9006) in Chemonäive Patients with Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
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LUN 90
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A Phase II Trial of Irinotecan, Carboplatin, and Bevacizumab in the Treatment of Patients with Extensive Stage Small Cell Lung Cancer
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LUN 120
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Phase II Study of Higher Dose Weekly Topotecan in the 2nd Line Treatment of Patients with Relapsed Extensive Stage Small Cell Lung Cancer
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PANCREATIC
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We have no pancreatic studies at this time.
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HEAD AND NECK
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We have no head and neck studies at this time.
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MISCELLANEOUS
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CRASH
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Chemotherapy Risk Assessment Score for High Age Patients; Design and Validation
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Moffitt
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UNK PRI 12
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A Randomized, Phase III Comparison of Gemcitabine/ Irinotecan Followed by ZD1839 (Iressaâ) versus Paclitaxel/Carboplatin/Etoposide Followed by ZD1839 (Iressaâ) in the First-Line Treatment of Patients with Carcinoma of Unknown Primary Site
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Perifosine 207
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A Phase IIA Trial of Two Schedules of Perifosine in Patients for Whom No Standard Therapy Exists
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GI Outcomes
(MCC 14495)
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Total Cancer Care Quality Improvement Protocol for Colorectal Cancer
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TCC—Total Cancer
Care (MCC 14690)
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Total Cancer Care: A Partnership with High Risk and/or Diagnosed Cancer Patients for Life
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PBI
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Partial Breast Irradiation Registry
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If you would like additional information about the Center for Research, please send your name, company or practice name, address and telephone number to the following address:
The Watson Clinic Center for Research
1600 Lakeland Hills Blvd
Lakeland, FL 33805
Attn: Noreen McGowan, BSN CCRC Administrative Coordinator
Phone (863) 688-6826 · FAX (863) 688-5842
Please indicate which of the following type(s) of information you would like:
Additional information about current protocols
Center for Research grants
Contributing to Center for Research funding
Involvement in Center for Research protocols