Cancer Disparities Research Partnership CDRP Clinical Trials

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Cancer Disparities Research Partnership (CDRP)
Clinical Trials

• Patrick D. Maguire, MD
• New Hanover Regional Medical Center
• Wilmington, NC

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CDRP Eastern Sites
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Radiation Oncology Community Outreach Group
(ROCOG)

• Dwight E. Heron, M.D.
• UPMC-McKeesport
• Western PA Consortium
• Pittsburgh, PA

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ROCOG sites

• 5 Hospital, 3 Health Systems
• UPMC McKeesport, McKeesport, PA (lead)
• Jameson Hospital, New Castle, PA
• Somerset Cancer Center, Somerset, PA
• UPMC Murtha Cancer Center, Johnstown, PA
• Mercy Cancer Center, Pittsburgh, PA
• National Mentors
• Roswell Park, Buffalo, NY
• Washington University, St. Louis, MO

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Clinical Trials ROCOG Breast

• Partial breast irradiation (investigator
  initiated)
• Breast brachytherapy
• External beam partial breast (3D CRTIMRT)
• Eligible patients
• T1 T2, N1 (no ECE) invasive breast cancer
• Uni-focal disease
• Negative margins
• Study Objective
• Acute toxicity
• Cosmesis
• Late toxicity
• Plan to roll into NSABP/RTOG partial breast
  irradiation when open in Winter 2004

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Clinical Trials ROCOG Prostate

• Hypofractionated RT with IMRT
• Phase I dose escalation
• Eligible patients
• Clinically localized adenocarcinoma of the
  prostate
• T1c-T3b, Gleason score 5-9 PSA 20.
• Neoadjuvant hormones for 2 months prior to XRT
• Treatment with IMRT
• Hypofractionation using 2.95 Gy/fraction to 59 Gy
  in 20 fractions other fractionation schemes to
  follow
• Study objectives
• Acute and chronic toxicity of hypofractionated
  IMRT
• Efficacy of hypofractionated RT for prostate

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Clinical Trials ROCOG Lung

• CDRP Partnership with Dr. Raymond Wynn--Lung
  Amifostine
• Eligible patients
• Investigator initiated Phase II
• Medically inoperable Stage II, IIIA, IIIB
• Study objective
• Incidence of treatment breaks
• Acute Chronic esophagitis, pneumonitis
• Impact of RT on pulmonary function (FEV1 DLCO)
• Planned enrollment of at least 10 patients

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Other Protocols under consideration

• Samarium-153 for osseous carcinomatosis
• Investigator-initiated
• Conformal RT for pancreatic cancer
• ECOG sponsored
• Dose escalation for prostate cancer
• RTOG

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Improving Cancer Outcomes for African-Americans
in Southeastern NC

• Patrick D. Maguire, MD
• New Hanover Regional Medical Center Wilmington, NC

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North Carolinas CDRP Team

• New Hanover Regional Medical Center (NHRMC)
• PI Maguire
• Co-PIs
• Hamann Kotwall
• UNC-Wilmington

• UNC-Chapel Hill
• Mentor Tepper
• Co-Mentors Rosenman Morris

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Local Research Team
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NHRMC

• Largest health care provider in Southeastern NC
  (New Hanover Health Network)
• Nine county service area, mostly rural
• Public, county-owned, JCAHO 87
• 769 beds tertiary, teaching hospital
• Surgery, Ob/Gyn, IM, Family Med Residencies

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Pilot 1 CMT for Advanced SCC of Head Neck
(SCCHN)
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Toxic Cure Results (N50)

• 2-year Survival 80
• 2-year PFS 75
• G3 Mucosal Toxicity 100
• Pharynx Stricture 15

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Phase II Trial of Hyperfractionated IMRT with
Concurrent Weekly Cisplatin for Stage III and IVa
SCCHN

• Investigator Initiated (NHRMC) Trial
• Zimmer Cancer Center (ZCC) 0204
• PI Patrick Maguire, MD

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ZCC 0204

• Eligibility III IVa, excluding N2c N3
• Regimen
• 70 Gy at 1.25 Gy bid to GTV
• CDDP at 33 mg/m2/wk
• Planned break after 40 Gy
• Endpoints
• Primary QOL Secondary Survival, PFS

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Expectations for ZCC 0204 Trial

• 10-15 patients per year
• 30 African Americans low income
• QOL prospective swallowing
• Collaboration with UNC-CH for IMRT expertise
  TELESYNERGY!!!

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Pilot 2 CMT for Stage III Non-Small Cell Lung
Cancer (NSCLC)
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Induction Chemotherapy Using Paclitaxel,
Carboplatin, and CPT-11 with Pegfilgrastim
Support Followed by Conformal Radiotherapy and
Paclitaxel/Carboplatin/ZD1839 in Unresectable
Stage IIIa/b NSCLC

• Mentor Institution (UNC) Trial
• Lineberger Comp Cancer Center (LCCC) 0215
• PI David Morris, MD

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LCCC 0215

• Patients
• Stage IIIa/b, unresectable
• Expect 30 African American
• Treatment
• RT - 74Gy qd
• Chemo induction concurrent
• Radiosensitizer - ZD1839 (Iressa)

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Cooperative Group Priority Trials for CDRP

• BREAST (CALGB 49801)
• Tam /- RT for Good Risk DCIS
• ANUS (RTOG 9811)
• RT/5FU MMC vs. CDDP
• PROSTATE (RTOG 0232)
• Brachy /- EBRT for Intermediate Risk
• LUNG PCI (RTOG 0214 0212)
• NSCLC (phase III) SCLC (3 fx schemes)

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Mississippi-Alabama Radiation Oncology Research
Project

• Raymond Wynn, M.D.
• Singing River Hospital
• Pascagoula, MS

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Mississippi-Alabama Radiation Oncology Research
Project

• Sharon Spencer, MD John Russell, MD
• Univ. Alabama CCC Gulf Coast MBCCOP
• Birmingham, AL Mobile, AL

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Pilot 1 IMRT for Head Neck Cancer

• Drs. Sharon Spencer, Judith Meredith, Raymond
  Wynn

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Pilot 2 Phase II Trial of Gamma Knife
Radiosurgery Temozolomide for Newly Diagnosed
Brain Metastases

• Drs. Raymond Wynn, Sharon Spencer, Joaquin
  Sariego

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RTOG Affiliation

• Approved through UAB
• Final group approval pending
• Nine (9) RTOG protocols IRB-approved
• Xerostomia/Mucositis trial under review