# Presentation: 089277

## Cancer Disparities Research Partnership (CDRP) Clinical Trials 

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

## 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 |

## Radiation Oncology Community Outreach Group (ROCOG)

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

## 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

## Clinical Trials: ROCOG Breast

- Partial breast irradiation (investigator initiated)
- Breast brachytherapy
- External beam partial breast (3D CRT±IMRT)
- 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

## 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

## 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

## Other Protocols under consideration

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

## Improving Cancer Outcomes for African-Americans in Southeastern NC

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

## North Carolina’s 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

## Local Research Team

## 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

## Pilot #1: CMT for Advanced SCC of Head & Neck (SCCHN)

## “Toxic Cure” Results (N=50)

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

## 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

## 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!!!

## Pilot #2: CMT for Stage III Non-Small Cell Lung Cancer (NSCLC)

## 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

## LCCC 0215

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

## 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)

## Mississippi-Alabama Radiation Oncology Research Project

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

## Mississippi-Alabama Radiation Oncology Research Project

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

## Pilot #1: IMRT for Head & Neck Cancer

- Drs. Sharon Spencer, Judith Meredith, & Raymond Wynn

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

- Drs. Raymond Wynn, Sharon Spencer, & Joaquin Sariego

## RTOG Affiliation

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