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CLINICAL TRIALS

• Breast Cancer
• Gastrointestinal
• Genitourinary
• Head & Neck
• Hematology
• Lung
• Melanoma / Sarcoma
• Miscellaneous
  

Over the years, Regional Consultants has cared for and treated thousands of cancer patients. We work hard to understand your needs and pride ourselves on delivering an exceptional care experience. Our goal is to provide you with the latest solutions to successfully treat your cancer and improve your quality of life. In our efforts to meet this goal, and with years of hard work and dedication, we are proud to say we have become a leader in cancer research, education and treatment.

Our team consists of a dedicated group of Board Certified oncologists, nurse practitioners, a physicianís assistant, chemotherapy nurses, and medical assistants. For extra assurance, an Oncopsychologist is available to help patients and their family members cope with the disease and changes that treatment may cause to their daily routine. We continue to stay on the cutting edge of medicine and provide the latest technologies and procedures, such as targeted chemotherapy and immunotherapy, for a level of care that is second to none.

Our physicians and staff are part of the leading cancer research team in North Florida and Southeast Georgia. The American Society of Clinical Oncology recognized this team in 2003 as one of the Top Five Outstanding Contributors to Cancer Clinical Trials in the United States. We are one of the top three most active research teams in the state of Florida due to the large number of clinical trials that our physicians participate in and support. We have active studies for most types of cancer; including colon, lung, and breast.

Due to our commitment to education and research, our physicians are highly sought after for lectures at cancer forums locally, nationally, and internationally. In our role as educators, not only do we instruct patients, we play an integral role in the training of future oncologists by working with them during their clinical rotations. We also contribute to the community by training local nurses in chemotherapy and related procedures.

At Regional Consultants, it is comforting to know that every new patientís condition is reviewed by all of our doctors. This allows your physician the opportunity to tap into our entire wealth of knowledge and provides for the highest level of care during treatment. We believe this ensures that all treatment options are covered and the best course of action is initiated in your care. Additionally, each patient has their own attending physician that oversees your cancer related healthcare needs from start to finish.

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BREAST CANCER RESEARCH

E4101
A Randomized Phase II Trial of Combination Anastrozole (NSC #719344) plus ZD 1839 (Iressa, NSC #715055, IND # 61187) and of Combination Fulvestrant (NSC#719276) plus ZD 1839 in the Treatment of Postmenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer

S0230
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

E2Z04
Quality of Life in Younger Breast Cancer Survivors
PACCT-1 Program for the Assessment of Clinical Cancer Tests (PACCT-
1): Trial AssigningIndividualized Options for Treatment: The TAILORx Trial

B-36
A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC), With or Without Celecoxib, in Patients With Node-Negative Breast Cancer

B-38
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)

B-37
A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-regional Relapse of Breast Cancer

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

B-40
A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens (Pending IRB)

FB-4
A Phase II Clinical Trial of Bevacizumab Beginning Concurrently with a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy Followed by Postoperative Bevacizumab Alone for Women with Locally Advanced Breast Cancer (Pending IRB)

AVF3694g
GENENTECH: A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Untreated Metastatic Breast Cancer

AVF3693g
GENENTECH: A Phase III, Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated Metastatic Breast Cancer

CZOL446E2352
NOVARTIS: A Prospective, Randomized, Double-Blind, Stratified, Placebo-Controlled, Multi-Center, 3-Arm Trial of the Continued Efficacy and Safety of Zometa (every 4 weeks vs every 12 weeks vs. placebo) in Patients with Documented Bone Metastases From Breast Cancer

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GASTROINTESTINAL RESEARCH

Z9001
A Phase III Randomized Double-Blind Study of Adjuvant STI571 (GleevecTM) Versus Placebo in Patients Following the Resection of Primary GastroIntestinal Stromal Tumor (GIST)

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

E5203
A Phase II Study to Evaluate Overall Response Rate of Bay 43-9006 (Sorafenib) Combined with Docetaxel and Cisplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma SUSPENDED 8/28/06

N0147 NCCTG/CTSU
A Randomized Phase III Trial of Irinotecan (CPT-11) and/or Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) after Curative Resection for Patients with Stage III Colon Cancer

R-04
A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum
NOVARTIS: Gastrointestinal Stromal Tumors (GIST)Registry Protocol

ML18491B ROCHE
“XELOX-A-DVS” (Dense vs Standard): A Randomized Study of Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q3W) and Bevacizumab v. Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q2W) and Bevacizumab as First-Line Treatment for Patients with Metastatic Colorectal Cancer

FR-1 NSABP
A Phase II Study to Determine the Efficacy and Safety of Panitumumab in Combination with Chemoradiotherapy for Unresectable or Locally Recurrent Adenocarcinoma of the Rectum With or Without Metastatic Disease

80101 CALBG/CTSU
Phase III Intergroup Trial of Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma

CAM201 CTI
Phase I/II study of CT-2106 in Combination with Infusional 5-Fluofouracil/Folinic Acid (5-FU/FA) (de Gramont schedule) as Second Lind in Patients with Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen

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GENITOURINARY RESEARCH

E3803
A Phase II Study of a Weekly Schedule of BMS-247550 for Patients with Hormone Refractory Prostate Cancer (Prior Taxane Stratum open to patients with measurable disease only) (“No Prior Chemotherapy” stratum closed to accrual 10/18/06) (“Two Prior Cytotoxic Chemotherapies” stratum suspended 11/21/06)

E1804
Phase II Trial of Sorafenib (BAY 43-9006) (IND 69896: NSC 724772) in Patients with Advanced Urothelial Cancer (“Transitional cell histology” cohort suspended 10/30/06)

E9802
A Phase II Study of PR (Vaccinia)/TRICOMandPROSTVAC-F (Fowlpox)/TRICOM with GM-CSF in Patients with PSA Progression After Local Therapy for Prostate Cancer

E2805
A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma

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HEAD AND NECK RESEARCH

E1302
Phase III Randomized, Placebo Controlled, Trial of Docetaxel versus Docetaxel Plus ZD1839 (Iressa, Gefitinib) in Performance Status 2 or Previously Treated Patients with Recurrent or Metastatic Head and Neck Cancer

E1304
Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (VELCADE™) in Combination with Irinotecan of PS-341 Alone Followed by the Addition of Irinotecan at Time of Progression in Patients with Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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HEMATOLOGY RESEARCH

E5998
A Phase II Study of Initial Treatment with Methotrexate in Large Granular Lymphocytic (LGL) Leukemia

E1900
A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification and Gemtuzumab-Ozogamicin Consolidation Therapy Prior to Autologous Stem Cell Transplantation (STEM CELL)

E4402
Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Patients with Low Tumor Burden Indolent non-Hodgkin’s Lymphoma

E3903
Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders

E2902
A Phase III Randomized Study of Farnesyl Transferase Inhibitor
R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission after Primary Induction Failure or Patients Over Age 60 in First Remission

E4A03
A Randomized Phase III Study of CC-5013 Plus Dexamethasone versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma with Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders

E2903
Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients with Chronic Lymphocytic Leukemia SUSPENDED 6/30/06

S0325
A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase

E1404
A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin’s Lymphoma (SUSPENDED 12/15/06)

E4903
A Phase II Study of Lenalidomide (CC-5013) in Combination with Prednisone for the Treatment of Myelofibrosis with Myeloid Metaplasia

E3404
Response Adapted Therapy for Aggressive non-Hodgkin’s Lymphoma Based on Early [18F] FDG-PET Scanning

E1905
A Randomized Phase II Trial of Azacitidine with or without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (dysplastic type), and Acute Myeloid Leukemia with Multilineage Dysplasia

20030213 AMGEN: An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

DO04-23-006 ORTHO BIOTEC: A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide plus Dexamethasone (Thal-Dex) versus DOXIL plus Thalidomide plus Dexamethasone (DOXIL-Thal-Dex) in Subjects with Newly Diagnosed Multiple Myeloma

20050161 AMGEN: A Retrospective, Observational Study of Patients with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Currently Enrolled in an AMG 531 Phase 3 Clinical Trial

GL305 GENTA: A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia (SUSPENDED 1/17/07)

310421 BERLEX: Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma

XL999-207 EXELIXIS: A Phase 2 Study of XL999 Administered Intravenously to Subjects with Acute Myeloid Leukemia (SUSPENDED 11/2/06)

XL999-203 EXELIXIS: A Phase 2 Study of XL999 Administered Intravenously to Subjects with Relapsed/Refractory Multiple Myeloma (SUSPENDED 11/2/06)

114-NH-301 BIOGEN IDEC: A Phase III, Randomized, Double-Blind Study of Galixumab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non-Hodgkin’s Lymphoma

CC-5013-CLL-001 CELGENE: A Multi-Center, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Two Lenalidomide Dose Regimens in Subjects with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (contract pending)

20060131 AMGEN: A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (contract pending)

P06-001 ALEXION Pharmaceuticals: Examination of PNH, by Level Of
CD59 on REd and white blood cells, in bone marrow failure syndromes (EXPLORE) (contract pending)

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LUNG RESEARCH

S9925
Lung Cancer Specimen Repository Protocol, Ancillary

E5501
A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced with Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced with Etoposide

E2501
A Double Blind Phase II Study of BAY 43-9006 in Patients with Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens

E1504
Phase II Study of C225 (Cetuximab) for the Treatment of Patients with Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma with BAC Features

E1B03
Pemetrexed Plus Gemcitabine or Carboplatin in Patients with Advanced Malignant Mesothelioma: A Randomized Phase II Trial

AVF3671g Genentech: A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy with or without Erlotinib after Completion of Chemotherapy with Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Squamous Non-Small Cell Lung Cancer

AVF3752g Genentech: A Phase II Trial of Bevacizumab in Combination with First- or Second-Line Therapy in Subjects with Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer

025-10 Merck: A Phase I/II Clinical Trial of Oral Vorinostat (MK-0683) in Combination With Erlotinib in Patients With Relapsed/Refractory Non-Small Cell Lung Cancer

D4200C00044 AstraZeneca: A Phase III, International, Randomized, Double-Blind, Parallel-Group, Multi-Centre Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) after Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) (contract pending)

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MELANOMA / SARCOMA RESEARCH

E1697
Randomized Study of Four Weeks High Dose IFN-a2b in Stage II-A Melanoma

S0008
Phase III Trial of High Dose Interferon Alpha-2b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma

E1602
A Randomized Phase II Trial of Multi-epitope Vaccination with Melanoma Peptides for Cytotoxic T-Cells and Helper T-Cells for Patients with Metastatic Melanoma

E2603
A Double-blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma

CA184022
Bristol-Myers Squibb: A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma

CA184025
Bristol-Myers Squibb: A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010) Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols
(Companion study to CA184022)

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