Group Title: Link : clinical trials newsletter
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Title: Link
Physical Description: Serial
Language: English
Creator: Shands Cancer Center, University of Florida
Publisher: Shands Cancer Center
Place of Publication: Gainesville, Fla.
Publication Date: Fall 2006
Copyright Date: 2006
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Bibliographic ID: UF00088872
Volume ID: VID00002
Source Institution: University of Florida
Holding Location: University of Florida
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Pediatric Oncology at the University of Florida Shands Cancer Center
leads the way in advancing clinical research

The University of Florida Shands Cancer Center's program in pediatric
hematology/oncology is the largest in the state of Florida, with seven full-
time physician faculty members and three full-time laboratory research faculty.
Appoximately 35 pediatric stem cell transplants (SCTs) are performed by the UF
pediatric hematology/oncology physicians at Shands at UF annually in children
throughout the state of Florida ranging from Miami to Pensacola. These SCTs are
performed with all donor types of children and adolescents with cancer and genetic

A major focus of the program is clinical research, spearheaded by Dr. Stephen
Hunger, Chief of the Division. Dr. Hunger also serves as Vice Chair of the Children's
Oncology Group (COG) Acute Lymphoblastic Leukemia (ALL) Disease Committee.
The COG ALL Committee is responsible to design, conduct and analyze pediatric
clinical trials and linked translational research studies. Most United States and
Canadian children with ALL are treated on COG ALL trials, with more than
2,000 patients being treated in 2005. The UF Shands Cancer Center Pediatric
Hematology/Oncology Program is an active participant in the COG and has the full
complement of COG trials open for patient enrollment. (continued on page 2)

Multidisciplinary coordinators facilitate care and provide easy access
for patients and referring physicians

The University of Florida Shands Cancer Center has established nurse coordinators
that provide a single point of access for patients and referring physicians. The nurse
coordinators oversee all aspects of care for cancer patients and serve a crucial
role as a liaison between patients, referring physicians and the multidisciplinary
team ensuring that communication is continuous among all parties. They play a
pivotal role in reducing the high anxiety time period for patients and help facilitate
education and screening for appropriate clinical trials. (continued on page 7)
Breast Center (352) 265-7070
Gigi Moore Higgs, ARNP, PhD(c), ACON Breast Center Coordinator
Lisa Arnett Business Service Representative
GI Oncology Center (352) 265-0990
Coleen Booker, RN GI Oncology Center Coordinator
Laura Buono Business Service Representative

University of Florida
Shands Cancer Center

Pediatric Oncology at the University of Florida Shands Cancer Center leads the way in
advancing clinical research (continued)

Another major clinical research emphasis of the UF Shands Cancer Center Pediatric Hematology/
Oncology Program is the development of Phase I and II trials for children with refractory cancer.
While more than 80 percent of children with cancer are cured with existing therapies, the outcome
is poor if the cancer recurs.

UF is one of nine founding members of the Pediatric Oncology Experimental Therapeutics
Investigators Consortium (POETIC), which designs and conducts early phase clinical trials. This
national network was founded in 2004 with the primary focus on providing new biologically-based
therapies. These trials are designed for children and adolescents with cancer who have previously
failed standard treatments. The UF Shands Cancer Center is the only cancer center in Florida with
an active pediatric Phase I clinical trials program and one of only a few in the Southeast.

POETIC Phase I trials that are active at this time include:

A Multi-Center Phase Ib Study of Oxaliplatin in
Combination with Fluorouracil and Leucovorin in
Pediatric Patients with Advanced Solid Tumors:

A Multi-Center Phase Ib Study of Oxaliplatin in
Combination with Fluorouracil and Leucovorin in
Pediatric Patients with Advanced Solid Tumors:
This POETIC trial, which is sponsored by the
National Cancer Institute, is the first study to test
the FOLFOX regimen in children and adolescents.
FOLFOX is widely used to treat cancers that occur in
adults, particularly colon and other gastrointestinal
cancers. Oxaliplatin, one of the central drugs of
the FOLFOX regimen, is related to Cisplatinum
and Carboplatinum, which are widely used in
pediatric cancers. Oxaliplatin avoids some of the
side effects of the other platinum compounds and
can be effective even in patients that have relapsed
following treatment with other platinum compounds.
This study will determine the safe dose of FOLFOX in
children, with plans to then test this regimen further
in children and adolescents with colon and liver
cancer. FOLFOX is also being tested in children with
brain tumors.

CA225085: a Phase I Study of Erbitux (Cetuximab)
in Pediatric Subjects with Refractory Solid Tumors:

CA225085: a Phase I Study of Erbitux (Cetuximab)
in Pediatric Subjects with Refractory Solid Tumors:
Characterization of Serum Pharmacokinetics, Safety,
and Efficacy of Cetuximab when Combined with
Irinotecan: This POETIC trial is the first study to
test the Cetuximab, a monoclonal antibody directed
against the epidermal growth factor receptor
(EGFR), in children and adolescents. Cetuximab
combined with chemotherapy drugs and/or radiation
therapy is used in the treatment of adults with colon
or head and neck cancer and is being studied in a
variety of other adult cancers. This trial is the first
to test Cetuximab in pediatric patients with relapsed
tumors, including brain tumors.


Pediatric Clinical Trials

Central Nervous System

ACNS0223: A Pilot Study Using Carboplatin, Vincristine
and Temazolomide For Children < 10 Years with
Progressive/Symptomatic Low-Grade Gliomas

ANBLOOP2: Perinatal Neuroblastoma: Expectant
Observation: A COG Pilot Study

Hematopoietic Malignancies

AALL0331: Standard Risk B-Precursor Acute
Lymphoblastic Leukemia: A Phase III Group-Wide Study

AAML0122: Phase II Window Evaluation of the Farnesyl
Transferase Inhibitor R115777 Followed by 13-cis Retinoic
Acid, Cytosine Arabinoside, and Fludarabine, Plus
Hematopoietic Stem Cell Transplantation in Children with
Juvenile Myelomonocytic Leukemia

HLH-2004: Hemophagocytic Lymphohistiocytosis Study
Group Treatment Protocol of the Second International
HLH Study 2004

P9407: Induction Intensification in Infant ALL: A
Children's Oncology Group Study

Solid Tumors

POETIC CA225-085: A Phase I Study of Erbitux
(Cetuximab) in Pediatric Subjects with Refractory Solid
Tumors: Characterization of Serum Phar macokinetics,
Safety, and Efficacy of Cetuximab When Combined with

Pediatric & Adult Clinical Trials

Central Nervous System

ACNS0121: A Phase II Trail of Conformal Radiation
Therapy For Pediatric Patients With Localized
Ependymoma, Chemotherapy Prior To Second
Surgery For Incompletely Resected Ependymoma and
Observation For Completely Resected, Differentiated.
Supratentorial Ependymoma

ACNS0122: A Phase II Study to Assess the Ability of
Neoadluvant Chemotherapy +/- Second Look Surgery to
Eliminate All Measurable Disease Prior to Radiotherapy

ACNS0221: A Phase II Study of Conformal Radiotherapy
In Patients with Low-Grade Gliomas

ACNS0331: A Study Evaluating Limited Traget Volume
Boost Irradiation and Reduced Dose Craniospinal
Radiotherapy (1800Gy) and Chemotherapy in Children
with Newly Diagnosed Standard Risk Medullobalstoma: A
Phase Ill Double Randomized Trial

ACNS0423: A Phase II Study of Concurrent Radiation
and Temozolomide Followed by Temozolomide and

Lomustine (CCNU) in the Treatment of Children with
High Grade Glioma

ANBL0032: A Phase IlI Randomized Study of Chimeric
anti-GD2 in High Risk Neuroblastoma Following
Myeloablative Therapy and Autologous Stem Cell Rescue

VP-16: A Phase 1/11 Trial of Temozolomide and Escalating
Doses of Oral VP-16 For Children and Young Adults with
Recurrent Brain Tumors


P9645: A Phase III Intergroup Protocol for the Treatment
of Children with Hepatoblastoma

Hematopoietic Malignancies

AALL0232: High Risk B-precursor Acute Lymphoblastic

AALL02P2: Treatment of Late Isolated Extramedullary
Relapse from Acute Lymphoblastic Leukemia (Initial CR >
18 months)

AAML0121: A Phase II Study of Amifostine in Children
with Myelodysplastic Syndrome

ADVL0222: Phase II Study of Campath-1H in Children
with Acute Lymphoblastic Leukemia in Second or
Greater Relapse, or Twice Induction Failure

AHOD0031: A Phase III Group-wide Study of Dose-
intensive Response-based Chemotherapy and Radiation
Therapy for Children and Adolescents with Newly
Diagnosed Intermediate Risk Hodgkin Disease

AHOD0321: A Phase II Study of Weekly Gemcitabine
and Vinorelbine in Children with Recurrent or Refractory
Hodgkins Disease

AHOD0431: A Phase III Study for the Treatment of
Children and Adolescents with Newly Diagnosed Low
Risk Hodgkin Disease

ANHL0131: A Phase III Trial of Treatment of Advanced-
Stage Anaplastic Large Cell Lymphoma (ALCL) with
Standard APO (Doxorubicin, Predisone, Vincristine)
versus Consolidation with a Regimen Including

ANHLO1P1: A Pilot Study to Determine the Toxicity of the
Addition of Rituximab to the Induction and Consolidation
Phases and the Addition of Rasburicase to the Reduction
Phase in Children with Newly Diagnosed Advanced
B-Cell Leukemia/Lymphoma Treated with LMB/FAB

ANHL0221: A Phase II Study of the Combination of
Cyclophosphamide, Prednisone and Rituximab (CPR)
in Children, Adolescents and Young Adults with CD20
Positive Post-Transplant Lymphoproliferative Disease
(PTLD) following Solid Organ Transplantation (SOT)

BCX-1777-Bi-04-106: A Phase 1/11, Multi-center, Open-
Label, Repeat-Dose Study of Forodesine Hydrochloride
Infusion in Patients with B-Cell Acute Lymphoblastic
Leukemia with an Option of Extended Use of Forodesine

BCX1777-T-04-201: A Phase II, Multi-Center, Open-Label,
Repeat-Dose Study of Forodesine Hydrochloride Infusion
in Patients with Advanced T-Cell Leukemia with an
Option of Long-Term Forodesine Hydrochloride Use

CTN0201: A Phase III Randomized, Multicenter Trial
Comparing G-CSF Mobilized Peripheral Blood Stem
Cell with Marrow Transplantation from HLA Compatible
Unrelated Donors

CTN0301: Fludarabine-based Conditioning for Allogeneic
Marrow Transplantation from HLA-Compatible Unrelated
Donors in Severe Aplastic Anemia

E2993: Phase III Randomized Trial of Autologous and
Allogeneic Bone Marrow Transplantation versus Intensive
Conventional Chemotherapy in Acute Lymphoblastic
Leukemia in First Remission

UFSCCVR2-2000: Immunoablative Conditioning
Regimens using Fludarabine, Busulfan, and Rabbit
Derived Anti-thymocyte Globulin (Thymoglobulin);
or Fludarabine with Low Dose Total Body Irradiation
Allowing Allogeneic Stem Cell Support in Patients with
Hematologic/Oncologic Diseases

UFSCC9806: Conditioning Regimen for Patients with
Severe Aplastic Anemia Transplanted with Stem Cells
from an Unrelated Donor

UFSCC: Umbilical Cord Blood Transplantation Using
Single or Multiple Cord Blood Units and a Non-
Myeloablative Preparative Regimen in Patients with High-
Risk Hematologic Malignancies or Bone Marrow States

UFSCC: Umbilical Cord Blood Transplantation Using
Single or Multiple Cord Blood Units and Standard
Dose Preparative Regimen in Patients with High-Risk
Hematologic Malignancies and Bone Marrow States


AEWS0331: European Ewing Tumor Working Initiative
of National Groups Ewing Tumor Studies 1999 (EURO-
E.WI.NG. 99)

AOST0221: A Phase II Study of Aerosolized GM-CSF
(NSC# 613795, IND# 11042) in Patients with First
Pulmonary Recurrence of Osteosarcoma

AOST0331: A Randomized Trial of the European and
American Osteosarcoma Study Group to Optimize
Treatment Strategies for Resectable Osteosarcoma
Based on Histiologic Response to Pre-Operative
Chemotherapy (EURAMOS 1)

ARST0121: A Groupwide Randomized Phase II Window
Study of Two Different Schedules of Irinotecan in
Combination with Vincristine and Pilot Assessment
of Safety and Efficacy of Tirapazamine Combined
with Multiagent Chemotherapy for First Relapse or
Progressive Disease in Rhabdomyosarcoma and Related

ARST0331: Vincristine, Dactinomycin, and Lower Doses
of Cyclophosphamide With or Without Radiation
Therapy for Patients with Newly Diagnosed Low-Risk
Embryonal/Botryoid Rabdomyosarcoma

SARC: Phase II Study of Sequential Gemcitabine
Followed by Docetaxel for Recurrent Ewings Sarcoma,
Osteosarcoma, or Unresectable or Locally Recurrent

Solid Tumors

ADVL0421: A Phase II Study of Oxaliplatin in Children
with Recurrent Solid Tumors

CTN0101: A Randomized Double-Blind Trial of
Fluconazole vs. Voriconazole for the Prevention of
Invasive Fungal Infections in Allogeneic Blood and
Marrow Transplant Patients

HLMCC0205: The Effect of Cyproheptadine
Hydrochloride (Periactin) and Megestrol Acetate
(Megace) on Weight in Children with Cancer/Treatment
Related Cachexia

POETIC 17-AAG: A Multicenter Phase I Trial of 17-
N allylamino-17 demethoxy geldanamycin (17-AAG,
NSC#330507) in Patients with Recurrent/Refractory
Pediatric Solid Tumors (Ewings Sarcoma, Desmoplastic
Small Round Cell Tumor, Osteosarcoma, Neuroblastoma,
and Rhabdomyosarcoma) and Leukemia, NCI Protocol
Number 6323

POETIC: A Multi-Center Phase Ib Study of Oxaliplatin
in Combination with Fluorouracil and Leucovorin in
Pediatric Patients with Advanced Solid Tumors

Adult Clinical Trials

Breast Cancer

EGF30008: A Randomized, Double-Blind, Placebo-
Controlled, Multicenter Phase III Study Comparing
GW572016 and Letrozole versus Letrozole in Subjects
with Estrogen/Progesterone Receptor-Positive Advanced
or Metastatic Breast Cancer

IBCSG 25-02: A Phase III Trial Evaluating The Role of
Exemestane Plus GnRH Analogue as Adjuvant Therapy
for Premenopausal Women with Endocrine Responsive
Breast Cancer

NSABP 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 Doxorubicin/
Cyclophosphamide Followed by DD Paclitaxel Plus
Gemcitabine (DD AC PG)

NSABP B-39: Phase III Randomized Study of Adjuvant
Whole Breast Versus Partial Breast Irradiation in Women
With Ductal Carcinoma In Situ or Stage I or II Breast

RTOG9804: Phase III Randomized Study of Tamoxifen
With or Without Radiotherapy in Women With Ductal
Carcinoma In Situ (DCIS) of the Breast

Z1031: A Randomized Phase III Trial of Comparing
16 to 18 Weeks of Neoadjuvant Exemestane (25 mg
daily), Letrozole (2-5 mg), or Anastrozole (1 mg) in Post
Menopausal Women with Clinical Stage II and III Estrogen
and/or Progesterone Receptor Positive Breast Cancer

3066A1303WW: Oral CCI-779 Administered in
Combination with Letrozole vs. Letrozole Alone in
Postmenopausal Women with Locally Advanced or
Metastatic Breast Cancer

Central Nervous System

RTOG0320: Phase IIl Randomized Study of Whole Brain
Radiotherapy and Stereotactic Radiosurgery With Versus
Without Temozolomide or Erlotinib in Patients With Non-
Small Cell Lung Cancer and Brain Metastases

RTOG0424: Phase II Study of Temozolomide and
Radiotherapy Followed By Temozolomide Alone in
Patients With High-Risk Low-Grade Gliomas


E1697: Phase III Randomized Study of Four Weeks High
Dose IFN-a2B In Stage T3-T4 (microscopic) 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


CA225006: Phase IIl Study of Irinotecan and Cetuximab
vs Irinotecan as Second-Line Treatment in Patients with
Metastatic, EGFR-Positive Colorectal Cancer

N0147: A Randomized Phase III Trial of Oxaliplatin
(OXAL) plus 5-Fluorouricil (5-FU)/Leucovorin (CF) with
or without Cetuximab (C225) after Curative Resection for
Patients with Stage III Colon Cancer

PACCE: A Randomized, Open-label, Controlled, Clinical
Trial of Chemotherapy and Bevacizumab with or without
Panitumumab in the First-line Treatment of Subjects with
Metastatic Colorectal Cancer

IJFSCC GI Rectal: A Phase II Trial of Neo-adjuvant
Capecitabine Combined with Hyperfractionated
Accelerated Radiation Therapy in Locally Advanced
Rectal Cancer

Z6041: A Phase II Trial of Neoadjuvant Chemoradiation
and Local Excision for UT2UNO Rectal Cancer

Z9001: A Phase III Randomized Double-Blind Study of
Adluvant STI571 (Gleevec) versus Placebo in Patients
Following The Resection of Primary Gastrointestinal
Stromal Tumor (GIST)

Head & Neck

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

RTOG0234: Phase II Randomized Study of Adjuvant
Cetuximab and Chemoradiotherapy Comprising
Cisplatin Versus Docetaxel in Patients With Resected
Stage III or IV Advanced Squamous Cell Carcinoma or
Lymphoepithelioma of the Head and Neck

RTOG0244: Phase II Study of Salivary Gland Transfer
Surgery Prior to Radiotherapy for the Prevention of
Radiation-Induced Xerostomia in Patients With Head and
Neck Cancer

RTOG0421: Phase III Randomized Study of Radiotherapy,
Cisplatin, and Paclitaxel Versus Cisplatin-Based
Chemotherapy Alone in Patients With Previously
Irradiated Unresectable Locally Recurrent Squamous Cell
Carcinoma of the Head and Neck

Hematopoietic Malignancies

AMD3100-3101: A Multicenter, Randomized, Double-
Blind, Placebo-Controlled, Comparative Trial of AMD3100
(240Qg/kg) Plus G-CSF (l0Qg/kg) Versus G-CSF (10Qg/
kg) Plus Placebo to Mobilize and Collect > 5x 10 CD34+
Cells/kg In Non-Hodgkin's Lymphoma Patients for
Autologous Transplantation

BRYOSTATIN1: A Phase II Study of Bryostatin 1 and
Vincristine in Patients with Low or Intermediate Grade
Non-Hodgkins Lymphoma Progressing or Relapsing after
a Prior Autologous Bone Marrow or Stem Cell Transplant

CLI-037: A Phase Ill Randomized Study of Cloretazine
(VNP40101M) and Cytosine Arabinoside (AraC) in
Patients with Acute Myeloid Leukemia in First Relapse

CTN0102: A Trial of Tandem Autologous Stem Cell
Transplants +/- Post Second Autologous Transplant
Maintenance Therapy Versus Single Autologous Stem
Cell Transplant Followed by HLA-Matched Sibling
Non-Myeloablative Allogeneic Stem Cell Transplant for
Patients with Multiple Myeloma

CTN0401: Phase III Rituxan/BEAM vs. Bexxar/BEAM with
Autologous Hematopoietic Stem Cell Transplantation
(ASCT) for Persistent or Relapsed Chemotherapy
Sensitive Diffuse Large B-cell Non-Hodgkin's Lymphoma

DACO-016: 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

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

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

E4402: Randomized Phase III Trial Comparing Two
Different Rituximab Dosing Regimens for Patients with
Low Tumor Burden Indolent Non-Hodgkins Lymphoma

PROLOGUE-EFC4978: Phase IV Randomized Study of
Rasburicase Alone Versus Rasburicase and Allopurinol
Versus Allopurinol Alone in Patients With Leukemia,
Lymphoma, or Solid Tumor Malignancy at Risk for
Hyperuricemia and Tumor Lysis Syndrome

SPD758-216: An Open-Label, Single-Arm, Multi-
Center, Phase 2/3 Study of TroxatylTM (Troxacitabine)
Administered by Continuous Infusion in Patients with
Acute Myeloid Leukemia (AML) in Second Salvage

Tandem MM: Total Therapy, Including Tandem High-Dose
Chemotherapy and Stem Cell Rescue for Patients with
Multiple Myeloma

UFSCC: GM-CSF and interferon-alpha maintenance
therapy for multiple myeloma patients after autologous
stem cell transplantation (ASCT) or induction

UFSCC: GM-CSF Treatment After High-Dose
Chemotherapy and Autologous Stem Cell Transplantation
(ASCT) for Lymphoma Patients with History of Poor
Peripheral Blood Stem Cell Mobilization

UPCC16403: The Study of Rasburicase in Treating or
Preventing High Uric Acid Blood Levels and Tumor
Lysis Syndrome in Patients With Relapsed or Refractory
Lymphoma, Leukemia, or Solid Tumors

0001A3-200-GL: Phase 2 Open-Label Study of
Amonafide L-Malate in Combination with Cytarabine in
Subjects with Secondary Acute Myeloid Leukemia (AML)


CA225099: A Randomized Multicenter Phase II Study
of Taxane/Carboplatin/Cetuximab Versus Taxane/
Carboplatin as First-Line Treatment for Patients With
Advanced/Metastatic Non-Small Cell Lung Cancer

ECOG5597: Phase III Randomized Chemoprevention
Study of Selenium in Participants With Previously
Resected Stage I Non-Small Cell Lung Cancer

RTOGL0117: Phase 1/11 Study of 3-Dimensional Conformal
Radiotherapy Concurrently With Paclitaxel and
Carboplatin in Patients With Inoperable Stage 1-IIIB Non-
Small Cell Lung Cancer


RTOG0123: Phase II Randomized Study of Captopril
Versus Observation in Patients With Stage 11-IIIB Non-
Small Cell Lung Cancer, Stage I Central Non-Small Cell
Lung Cancer, or Limited Stage Small Cell Lung Cancer
Previously Treated With Radiotherapy With or Without

RTOG0212: Phase II/III Randomized Study of Prophylactic
Cranial Irradiation in Patients With Limited Stage Small
Cell Lung Cancer

RTOG0214: Phase III Randomized Study of Prophylactic
Cranial Irradiation in Patients With Stage IIIA or IIIB Non-
Small Cell Lung Cancer

RTOGO236: Phase II Study of Stereotactic Body
Radiotherapy in Patients With Medically Inoperable
Stage I or II Non-Small Cell Lung Cancer


MDXO1020: MDX-010 Antibody, MDX-1379 Melanoma
Vaccine, or MDX-010,'MDX-1379 Combination Treatment
for Patients with Melanoma


CANNCICSC20: Phase III Randomized Study of Single
Fraction Versus Multiple Fraction Re-Irradiation in
Patients With Painful Bone Metastases

SWOGS0344: Phase II Study of Intralesional Resection
in Patients With Low-Grade Intracompartmental
Chondrosarcoma of the Bone

Soft Tissue

RTOG0330: Phase II Pilot Study of Pre-Operative
Thalidomide With Raciotherapy Alone in Patients
With Low-Grade Primary Soft Tissue Sarcoma or
With Radiotherapy and Doxorubicin, Ifosfamide, and
Dacarbazine in Patients With High- or Intermediate-
Grade Primary Soft Tissue


RTOGP0126: Phase III Randomized Study of High-
Versus Standard-Dose Three-Dimensional Conformal or
Intensity-Modulated Radiotherapy in Patients With Stage
I or II Adenocarcinoma of the Prostate

RTOG0232: Phase III Randomized Study of Interstitial
Brachytherapy With or Without External Beam
Radiotherapy in Patients With Intermediate-Risk Prostate

RTOG0233: Phase II Randomized Study of Induction
Paclitaxel, Cisplatin, and Radiotherapy Versus
Fluorouracil, Cisplatin, and Radiotherapy Followed By
Consolidation Chemoradiotherapy or Radical Cystectomy
and Adjuvant Gemcitabine, Paclitaxel, and Cisplatin in
Patients with Bladder Cancer

ASCENT2: A Phase 3, Randomized, Open-Label Study
Evaluating DN-101 in Combination with Docetaxel in
Androgen-Independent Prostate Cancer (AIPC) u

Breast Center

The Breast Center provides services to women with breast disease, as well as
those diagnosed with breast cancer. The multidisciplinary team of UF physicians
from every oncology discipline work collaboratively to develop the optimal
treatment plan for each individual. Our Breast Center team consistently leads the
way in developing innovative treatments and therapies. Current research by some
of our nationally recognized team members include:
Edward M. Copeland, M.D.
Minimizing local recurrence after breast conserving therapy using
intraoperative shaved margins to determine pathologic tumor clearance
Sentinel lymph node biopsy for ductal carcinoma in situ
William G. Cance, M.D.
Tumor Markers to Predict Treatment Response in Elderly Breast Cancer Patients
Focal Adhesion Kinase Tumor Biology and Therapeutics
Stephen Grobmyer, M.D.
Class Prediction in Breast Cancer
Optical Imaging of Breast Cancer

For more information about the UF Shands Cancer Center, Breast Center, visit To schedule an appointment, call (352) 265-7070.

The GI Oncology Center

The UF Shands Cancer Center's multidisciplinary GI team cares for more than
700 patients with esophageal, gastric, pancreatic, biliary, hepatic, colorectal or
retroperitoneal malignancies. Patient outcomes have consistently demonstrated
low morbidity and mortality for the treatment of patients with complicated
gastrointestinal malignancies. Some unique and state-of-the-art therapies that are
available at the UF Shands Cancer Center, GI Oncology Center are:
Sphincter preserving procedures including: transanal resection, transanal
endoscopic microsurgery, transsacral resection and low rectal cancer
resection with coloanal J pouch reconstruction
Sphincter preserving chemo-radiotherapy for anal canal / margin carcinoma
Minimally invasive or laparoscopic resection of the colon and rectum and
pancreas and for other areas of the gastrointestinal tract.
Spleen preserving pancreatic surgery
Sentinel lymph node biopsy for some gastrointestinal tract cancers
Precision external beam radiotherapy including: 3DCRTIMRTIGRTSRT
Intraoperative radiotherapy services including: brachytherapy for
retroperitoneal sarcoma and recurrent malignancies after prior radiotherapy.
Radiofrequency ablation of liver tumors
Chemoembolization of liver tumors
Radioactive micro-spheres for the treatment of liver tumors
Proton beam therapy for some gastrointestinal malignancies
Transhiatal or transthoracic esophagectomy

For more information about the UF Shands Cancer Center, GI Oncology Center,
visit To schedule an appointment, call (352) 265-0990.

On the Web

The UF Shands
Cancer Center's
Web site has many
resources, including:
the Healthcare
Professional Section
and the Clinical Trials

The Healthcare
Professional Section
can be accessed
directly at ufscc.ufl.
edu/professional and
includes information
and resources that
will be especially
helpful to those
involved in clinical

The Clinical Trials
Section provides an
interactive clinical
trial matching and
referral service
that is confidential
and free of charge
This service
provides patients
and physicians an
easy and efficient
way of determining
available trials that
are appropriate for
enrollment. This
service can also be
accessed by calling

The h The Link is a publication of the
s Li 1 University of Florida Shands Cancer Center

W Stratford May, Jr, MD, PhD
Deputy Director
John R Wingard, MD
Chief Administrative Officer
Joseph F Woelkers, MA
Director, Marketing & PR
Diane K Hammon, MHA
Director, Clinical Trials Office
Robert D Marsh, MD
Assistant Director, Clinical Trials Office
Renee Boyette, BSN, OCN, CCRC
Stephen P Hunger, MD
Editor & Layout
Courtney P Holmes
Stephen Preston

Shands Cancer Center
P.O. Box 103633
Gainesville, Fla. 32610

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