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Cancer Disparities Research Partnership (CDRP) Clinical Trials

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Cancer Disparities Research Partnership (CDRP) Clinical Trials ... Wilmington, NC CDRP Eastern Sites Radiation Oncology Community ... Trial Lineberger Comp ... – PowerPoint PPT presentation

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Title: Cancer Disparities Research Partnership (CDRP) Clinical Trials


1
Cancer Disparities Research Partnership (CDRP)
Clinical Trials
  • Patrick D. Maguire, MD
  • New Hanover Regional Medical Center
  • Wilmington, NC

2
CDRP Eastern Sites
Hospital UPMC -McKeesport Location Pittsburgh, PA PI D Heron
New Hanover Regional Wilmington, NC P Maguire
Singing River Pascagoula, MS R Wynn
3
Radiation Oncology Community Outreach Group
(ROCOG)
  • Dwight E. Heron, M.D.
  • UPMC-McKeesport
  • Western PA Consortium
  • Pittsburgh, PA

4
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

5
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

6
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

7
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

8
Other Protocols under consideration
  • Samarium-153 for osseous carcinomatosis
  • Investigator-initiated
  • Conformal RT for pancreatic cancer
  • ECOG sponsored
  • Dose escalation for prostate cancer
  • RTOG

9
Improving Cancer Outcomes for African-Americans
in Southeastern NC
  • Patrick D. Maguire, MD
  • New Hanover Regional Medical Center Wilmington, NC

10
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

11
Local Research Team
12
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

13
Pilot 1 CMT for Advanced SCC of Head Neck
(SCCHN)
14
Toxic Cure Results (N50)
  • 2-year Survival 80
  • 2-year PFS 75
  • G3 Mucosal Toxicity 100
  • Pharynx Stricture 15

15
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

16
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

17
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!!!

18
Pilot 2 CMT for Stage III Non-Small Cell Lung
Cancer (NSCLC)
19
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

20
LCCC 0215
  • Patients
  • Stage IIIa/b, unresectable
  • Expect 30 African American
  • Treatment
  • RT - 74Gy qd
  • Chemo induction concurrent
  • Radiosensitizer - ZD1839 (Iressa)

21
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)

22
Mississippi-Alabama Radiation Oncology Research
Project
  • Raymond Wynn, M.D.
  • Singing River Hospital
  • Pascagoula, MS

23
Mississippi-Alabama Radiation Oncology Research
Project
  • Sharon Spencer, MD John Russell, MD
  • Univ. Alabama CCC Gulf Coast MBCCOP
  • Birmingham, AL Mobile, AL

24
Pilot 1 IMRT for Head Neck Cancer
  • Drs. Sharon Spencer, Judith Meredith, Raymond
    Wynn

25
Pilot 2 Phase II Trial of Gamma Knife
Radiosurgery Temozolomide for Newly Diagnosed
Brain Metastases
  • Drs. Raymond Wynn, Sharon Spencer, Joaquin
    Sariego

26
RTOG Affiliation
  • Approved through UAB
  • Final group approval pending
  • Nine (9) RTOG protocols IRB-approved
  • Xerostomia/Mucositis trial under review
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