Progress Report, June 2006: CDRP Grant Programs

1. Progress Report, June 2006:CDRP Grant Programs Singing River Hospital System Pascagoula, Mississippi

3. Radiation Oncology Research Partnership W. Sam Dennis, PhD, MD P.I., Singing River Hospital System Sharon Spencer, MD P.I., University of Alabama Comp. CA Center – Birmingham Vince Herron, MD P.I., University of Mississippi Medical center

4. Organizational Update • Added University of Mississippi Medical Center as a partner, Replacing Mobile Infirmary • Staffing Changes

5. MS/AL RADIATION THERAPY RESEARCH PROGRAM STAFFING PLAN UMISS SRHS UAB P.I. – Dr. Vince Herron - - - - - - - - - - - - - - - - - - P.I. – Dennis (10%)- - - - - - - - - - - - - - - - - - - - P.I. – Sharon Spencer (12%) CO – P.I.Grants Administrator(0.6 FTE)PROGRAM DIRECTOR (1 FTE) Clarkson (3%) Susan BoscoMaggie Clarkson Hull (3%) Administrative Assistant (.5 FTE) Ellita Henderson RESEARCH STAFFOUTREACH STAFF (*)PATIENT NAVIGATOR Research Nurse (1 FTE) Health Educator/RN (1 FTE) Patient Navigator (1 FTE) Gail Recore RNKathy ScottAmy Linton Clinical Research Assoc (1 FTE) Van Driver ( .5 FTE) Mitchell Harala MT (ASCP) TBA CONTRACT: Biostatistician @ $5,000/year *Shared oversight with Director, Cindy Rawlings, Community and Corporate Wellness Program

6. Review: Major Events of 2005 • Prior P.I. left. • Proposal for restructured Grant submitted to NIH, and NIH accepted. • New P.I. • Hurricane Katrina. • Restructuring implemented and operations were begun.

7. Review: Grant Restructuring Plan • Day-to-day operations of Grant to be handled by Project Director rather than P.I. • Full time research nurse/case finder, rather than carving out a percentage of time of an otherwise-occupied clinic nurse. • Full time clinical associate/data manager. • P.I. @ 10% time rather than 25%. • Grants Administrator @ 60% rather than 100%.

8. Accomplishments:Organizational Level • Budget reorganization submitted and approved through 2008 • RT facility accreditation with ATC • H/N phantom submitted, approved June 1st • RTOG 0126 Prostate study review still pending

9. Accomplishments: Clinical Research Activities • Total of 32 patients on active study patient roster • Includes 15 Keesler AFB transfers • 16 open studies • Total cases screened Nov-May = 178 • Male = 72 Female = 106 • Asian = 1 Black = 24 White = 153 • Total newly accrued patients = 2 • 2 white female, breast cancers

10. Results of Screened Cases, 178 pts. No Study Available: 130 cases Breast 21 Colon 6 Lung 20 Testicular 5 H/N Sites 14 Melanoma 4 Lymphoma 12 SC Skin 3 Prostate 12 Rectal 2 Study Available (Site/Stage): 48 Not Eligible 22 MD Preference to trx off-study 12 Patient Declined 3 Other 9 ACCRUED 2

11. SINGING RIVER HOSPITAL SYSTEM - CANCER CENTER OPEN STUDIES - June 2006 BLADDER SWOG S0219 Stage III: neoadj gemcitabine, Paclitaxel + Carbo BREAST NSABP B35 DCIS POSTMENOPAUSAL, Anastrozole vs. Tam for pts. trx with lumpectomy + RT NSABP B36 NODE NEG: FEC x 6 vs. AC x 4 NSABP B38 NODE POS: TAC vs. DD AC→P vs DD AC →P vs DD AC→PG SWOG S0221 NODE +/HIGH-RISK NODE NEG, AC+G vs q2 week AC → P either q 2 weeks or weekly x 12 CALGB 40101 NODE = 0-3: CTX + ADR (4 vs 6 cycle) vs. Paclitaxel (4 vs. 6 cycles) CALGB 49907 Elderly (> 65 yoa), NODE + or NEG: CMF or AC vs Capecitabine NCIC MA.20 NODE +/ Hi-risk NODE NEG, postop: Regional RT vs. partial RT COLON ECOG E5202 RESECTED STAGE II: Hi-risk vs Low-risk per molecular markers mFOLFOX6 vs. mFOLFOX6 + Avastin (Hi-risk) vs observation (Lo-risk) NSABP C08 RESECTED STAGE II/III: mFOLFOX6 vs. mFOLFOX6 + Avastin EFC 5505 1ST LINE METASTATIC COLORECTAL (sanofi-aventis) mFOLFOX6 + Xaliproden vs mFOLFOX6 + placebo (can use Avastin) HEAD/NECK RTOG 0234 ADVANCED SQUAMOUS CELL, postop RT + Cisplatin + Cetuximab vs. RT + docetaxel + Cetuximab LUNG RTOG 0212 LIMITED SMALL CELL, Prophylactic whole brain RTOG 0214 LOCALLY ADVANCED NSC, Prophylactic whole brain SWOG S9925 Specimen Repository PROSTATE RTOG 0126 LOCALIZED: Hi dose 3D- CRT/IMRT vs. standard dose 3D-CRT/IMRT

12. Accomplishments: Research Office Tools Developed • Casefinding Logs • All new referrals to Cancer Center are screened & tracked for final trx plan • Casefinding Forms/packet (for M.D.) • Communication form for consult visit with Fast Fact Sheet attached for any potential study • Patient Fast Fact Sheets (for Pt.) • Study-specific brief intro handout given to patients during treatment planning process (IRB approved) • Study Patient Identification/Info Cards (Re: hurricane) • For use with study patients in the event of evacuation, contains study sponsor contact info and study-specific patient ID number • Used in collaboration with study calendar for individual patient

13. CLINICAL RESEARCH TRIAL – PATIENT FAST FACT SHEET CALGB 49907 – Breast Cancer Study We would like to provide some very basic information about a clinical trial that your physician has begun to discuss with you. Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. The goal of this research is to find better ways to treat cancer and help cancer patients. As one of your treatment choices, you are being asked to consider participating in this clinical trial because you are a woman 65 years of age or older with early stagebreastcancer that has been removed by surgery. We believe that you may meet the eligibility requirements for this study. This trial is being conducted in many locations by the National Cancer Institute through a research group called CALGB. The Singing River Hospital System Regional Cancer Center is conducting the study locally. It is expected that about 600-1,800 people will join this study. WHY IS THIS RESEARCH STUDY BEING DONE? The purpose of this study is to compare the safety and effectiveness of adjuvant combination chemotherapy using either cyclophosphamide + methotrexate + 5-flurouracil (CMF), or doxorubicin (also called Adriamycin) + cyclophosphamide (AC), with the chemotherapy drug capecitabine, in women 65 years of age and older. The study will also help gain more information about the effects of each of the treatments on physical and emotional well-being and how well the participants assigned to receive capecitabine follow the treatment plan. WHAT ARE THE TREATMENT POSSIBILITIES? You will be “randomized” into one of the treatment groups described below. Randomization means that you are assigned to a group by chance. The treatment group you are assigned to is chosen by a computer. Neither you nor your doctor will choose which group you will be in. You will have an equal chance of being assigned to either group. Treatment A If you are assigned to this treatment group, you and your doctor will decide whether you will receive the CMF or the AC standard combination chemotherapy. These treatments are given as outpatient treatment in the clinic.  If you choose CMF, you will be given a prescription for cyclophosphamide tablets, which you will take by mouth, daily for 14 days. You will be given methotrexate and 5-fluorouracil, through a vein, on days 1 and 8. This treatment will be repeated every 28 days. This 28 day period is called a treatment cycle. You will receive 6 cycles of this treatment.  If you choose AC, you will be given doxorubicin and cyclophosphamide through a vein on day 1, every 21 days. This 21 day period is called a treatment cycle. You will receive 4 cycles of this treatment. Treatment B If you are assigned to this treatment group you will be given a supply of capecitabine tablets, which you will take at home, by mouth, twice daily for 14 days. This treatment will be repeated every 21 days. This 21 day period is called a treatment cycle. You will receive 6 cycles of this treatment. The study staff will give you additional instructions on how to take the capecitabine. (con’td – next page)

14. CLINICAL RESEARCH TRIAL – PATIENT FAST FACT SHEET (CON’TD) CALGB 49907 – Breast Cancer Study All Treatment Groups After you have completed the study treatment, if your breast cancer is the type that is responsive to hormones your doctor may recommend hormonal therapy with tamoxifen, anastrozole, exemstane or lettozoloe. WHAT TESTS ARE INVOLVED? If you take part in this study, you will have the following routine tests and procedures before the study treatment begins: you will be asked to give your medical history and have a physical examination, blood tests, a chest x-ray and a mammogram. If you are going to receive the AC treatment, you will have a MUGA scan or an echocardiogram, which measure your heart’s ability to pump. During the time that you are receiving the study treatment, a physical examination and blood tests will be done on day 1 of each treatment cycle. If you are receiving the CMF treatment blood tests will also be done on day 8 of each cycle. MUGA scans or echocardiograms will be done as your doctor feels necessary. After the study treatment has been completed, the physical examinations will be done every 6 months for 2 years, then annually thereafter. The blood tests and mammograms will be done annually. HOW LONG ARE PARTICIPANTS IN THE STUDY? We think you will receive study treatment for 3 to 6 months, depending on which treatment group you are assigned to. After the treatment has been completed your doctor will follow your medical condition for up to 15 years to learn about the long-term effects of the study. WHAT’S NEXT? Your doctor will discuss your treatment options with you again, including the opportunity to participate in this study. If you are interested and you and your doctor agree that this study would be of potential benefit to you in treating your cancer, the Research Nurse will do further evaluation of your records to make sure you are fully eligible to join the study. If you qualify to join the study, you will be given as much time as needed to ask questions and make an informed decision. We have a research nurse available to help answer your questions. WHERE CAN YOU GET MORE INFORMATION? If you are interested in learning more about the opportunity to participate in this research study, please let your doctor know. You may call the Singing River Regional Cancer Center Research Nurse at 228-809-5639 or e-mail M_RECORE@srhshealth.com. You can call the Cancer Information Service at 1-800-4-CANCER or visit the National Cancer Institute’s Cancer Trials Web Site at http://www.cancer.gov/clinicaltrials for information on clinical trials or http://www.cancer.gov/cancerinformation for information on cancer.

15. Accomplishments: TeleSynergy • Regular Administrative/Program Meetings • Research office staffs monthly meetings • CDRP Navigator meetings (quarterly) • Partner Meetings (almost regular) • Review for study activations • Program updates • Additional Equipment at SRHS • Additional Site at U. Miss

16. Accomplishments: Patient Navigator Program • Assessment/monitoring tools • Documentation in electronic medical record • Supports internal monitoring/analysis • Patient Navigator Brochure • Redesigned for patient focus • Satisfaction Survey • Scheduled for July

17. Patient Navigator Program:Changes • One Navigator • 0.5 FTE van driver

18. Community Outreach Program • Materials development • Awareness, education, screening • Topics: Cancer Risk Quiz, Colorectal, Skin Cancer, Tobacco Cessation • Assessment/monitoring methods • Cancer Protective Practices • Pre/Post with Intent to Practice measure • Program evaluation • Community-based programs • Senior centers, businesses, post offices, schools • Cancer Center programs • Monthly education programs • Cancer support groups • RT and Chemo group classes

19. Community Outreach Program (cont) • Physician Outreach: working toward re-establishing regular meetings with community physicians.

20. Summary • Largely recovered from Hurricane Katrina • Staffing is in place (one exception) • Case screening going forward, 2 accruals • Community outreach activities progressing • Navigator Program progressing • Providing research follow-up for 30 research patients from Keesler and from our facility.