Cancer Disparities Research Partnership CDRP Clinical Trials Patrick

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

CDRP “Eastern” Sites Hospital: UPMC Mc. Keesport 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-Mc. Keesport & Western PA Consortium Pittsburgh, PA

ROCOG sites 5 Hospital, 3 Health Systems l l l UPMC Mc. Keesport, 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 l l Roswell Park, Buffalo, NY Washington University, St. Louis, MO

Clinical Trials: ROCOG Breast Partial breast irradiation (investigator initiated) l l l Breast brachytherapy External beam partial breast (3 D CRT±IMRT) Eligible patients l l Study Objective l l T 1 & T 2, N 1 (no ECE) invasive breast cancer Uni-focal disease Negative margins 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 l l Phase I dose escalation Eligible patients: l Clinically localized adenocarcinoma of the prostate l l l T 1 c-T 3 b, 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: l l 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 l Eligible patients l l l Study objective: l l Investigator initiated Phase II Medically inoperable Stage II, IIIA, IIIB Incidence of treatment breaks Acute & Chronic esophagitis, pneumonitis Impact of RT on pulmonary function (FEV 1 & DLCO) Planned enrollment of at least 10 patients

Other Protocols under consideration Samarium-153 for osseous carcinomatosis l Investigator-initiated Conformal RT for pancreatic cancer l ECOG sponsored Dose escalation for prostate cancer l 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) UNC-Chapel Hill PI: Maguire Co-PIs: Hamann & Kotwall Mentor: Tepper Co-Mentors: Rosenman & Morris UNC-Wilmington

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 l 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% G 3 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 N 2 c & N 3 Regimen: 70 Gy at 1. 25 Gy bid to GTV l CDDP at 33 mg/m 2/wk l Planned break after 40 Gy l Endpoints: l 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/ ZD 1839 in Unresectable Stage IIIa/b NSCLC Mentor Institution (UNC) Trial Lineberger Comp Cancer Center (LCCC) 0215 PI: David Morris, MD

LCCC 0215 Patients: l Stage IIIa/b, unresectable l Expect 30% African American Treatment: l RT - 74 Gy qd l Chemo – induction & concurrent l Radiosensitizer - ZD 1839 (Iressa)

Cooperative Group Priority Trials for CDRP BREAST (CALGB 49801): l Tam +/- RT for “Good Risk” DCIS ANUS (RTOG 9811): l RT/5 FU + MMC vs. CDDP PROSTATE (RTOG 0232): l Brachy +/- EBRT for Intermediate Risk LUNG PCI (RTOG 0214 & 0212): l 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 Univ. Alabama CCC Birmingham, AL John Russell, MD Gulf Coast MBCCOP 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 IRBapproved Xerostomia/Mucositis trial under review