CRO Monthly Communique

CRO Communiqué

Keeping you informed about CRO progress

May 2010

Top Enrolling Physicians for Grant Year - (6/1/09 – 5/31/10)

April was the third straight good enrollment month for CRO. We had 24 enrollments to 17 different studies during April.  Cox had another excellent month with 14 of our enrollments coming from this location.  We now have 109.8 treatment credits.  Our treatment credits target is 130 for the year.  Our control credits are at 50.5 and our target is 90. Our grant year ends on May 31^st.  We are hoping for another good month so we can meet our target treatment credits of 130, but it is doubtful we will be able to meet our target control credits of 90 for this grant year.   Special thanks to all enrolling physicians.  Above are our enrollment stars.    

Research Discovery
An update of the results of the Study of Raloxifene and Tamoxifen, (NSABP P-2 STAR trial in

breast cancer prevention) shows that the drug raloxifene (initially used to prevent and treat osteoporosis in postmenopausal women) was more effective against noninvasive breast cancer, caused significantly less endometrial cancer and was significantly less toxic than tamoxifen.  Although raloxifene was slightly less effective against invasive breast cancer, it still maintained strong efficacy after 81 months of follow-up. 

Cancer Research for the Ozarks participated in the STAR Study, one of the largest breast cancer prevention clinical trials ever conducted.  STAR enrolled 19,490 postmenopausal women who were at increased risk for the disease in the follow-up study.   At CRO, 101 women were enrolled in the trial between July 1999 when it opened and January 2005 when it closed.  We continue to follow-up with these ladies on an annual basis.  This is a great study with very significant results for breast cancer prevention.  

NCI Cooperative Group Programs
For the past 50 years, NCI’s 10 Cooperative Groups have been very successful in developing new and improved therapies…however, many stakeholders have expressed concerns that the program is falling short of its potential.  As a result NCI asked the Institute of Medicine to assess the state of cancer clinical trials, review the Cooperative Group Program and provide advice for improvements. Their recommendations are found in a report entitled, “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program”.  The link to the Institute of Medicine’s Report on the Cooperative Groups is at

http://www.iom.edu/Reports/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative.aspx  This report has great merit for the research world and CRO.  I encourage you to take a few minutes and review the 4 page report. 

Dr. Carolla Auditor for Moffitt Research Base

CRO’s Principal Investigator, Robert Carolla MD, was in Tampa, Florida auditing Moffitt research Base on April 27^th & 28^th.  Information he gains from his auditing experience is an asset to CRO in preparing for our Cooperative Group audits and assists us to become an even better CCOP.    

CRO Communiqué

Keeping you informed about CRO progress

August 2010

    Top Enrolling Physicians for Grant Year - (6/1/10 – 5/31/11)

Two months into our grant year we have 29 registrations which have earned us 21.5 treatment and 6.0 cancer control credits.  We are 1.5 credits above where we need to be to meet our NCI target treatment credit of 120.  YEA!! To be on target to meet our NCI target cancer control credits we should be at 11.6 control credits, so we need to work to get our control credits up.  We appreciate each enrollment and all efforts to get a patient enrolled.  
Community Health Educator Grant Opportunity.  NCI has announced the availability of an administrative supplement to NCI-sponsored grants and cooperative agreement awards that are pertinent to the (NON) National Outreach Network.  The intent is to expand community outreach capacity, such that cancer information is relevantly disseminated to diverse communities. CRO is in process of drafting a grant proposal for this opportunity and will submit an application on or prior to August 6^th.  CRO has selected a health disparity project of working with prenatal patients seen at the Greene County Health Department’s WIC office on a tobacco cessation program.  The grant is highly competitive with over 100 listening in on the webinar explaining the opportunity. Only 17 grants will be approved.   

CRO Steering Committee Meeting & Dinner Rescheduled for Sept. 27th

CRO apologizes for cancellation of our Steering Committee meeting on July 27^th.  Our speaker canceled less than a week before the event due to complications from surgery and being placed on bed rest.   Dr. Nora Bucher has rescheduled with us for Monday, September 26th at Metropolitan Grill at 6pm to share information on pharmacokenetically guided dosing using Area Under the Curve rather than traditional BSA dosing.  Area Under the Curve is a much more personalized and efficacious way to dose patients and the process is now commercially available through Myriad Genetics.  Studies have shown very little correlation between BSA and 5-FU clearance and studies have indicated greatly elevated levels of efficacy as well as reduced toxicity in patients dosed in this manner.  If you would like to attend and we hope you do, please RSVP to 417-269-4520 by September 20th, 2010, or email debbie.cane@coxhealth.com

New Studies Approval and Available at CRO

N1031 “Randomized Phase II Study of Two Doses of  Pixantrone in Patients with Metastatic Breast Cancer”
CALGB 40603  “ Randomized Phase II 2 X 2 Factorial Trial of the addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer”

Closed studies for July IRB:

NSABP B-40  A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens

CRO Communiqué

Keeping you informed about CRO progress

July 2010

Top Enrolling Physicians for Grant Year - (6/1/09 – 5/31/10)

Above are our CRO All Star top enrolling investigators for grant year 2009-2010.  Congratulations to our top enroller Dr. Raju who had 19 registrations to clinical trials this past grant year. Thanks to all our investigators for enrolling patients.  We appreciate your caring enough to give your patients the very best of oncology care by placing them on a clinical trial.    

Top Enrolling Physicians for Grant Year - (6/1/10 – 5/31/11)

We understand the competition is on with our investigators to see who can enroll the most this year. 
This is exciting!  Everything is more fun when you make it a contest.   At the end of our first month into this grant year any investigator can still win.   There were thirteen enrollments for the month of June.

NCI Target Credits for grant year 2010-2011

CRO has been notified that our target treatment credits for grant year is 120 which is down 10 credits from the previous year.  Our cancer control credits have been reduced from 90 to 70 for this year.  CRO staff have pledged to do their best to enroll every eligible person we can into a clinical trial. If we all make this pledge, we can make our target enrollments but most importantly our patients will be getting the very best cancer care.  Our total credits for June the fist grant month of our grant year is 12.  

CRO Steering Committee Meeting and Dinner on July 26^th

Dr. Nora Bucher will be with us on Monday, July 26^th at Metropolitan Grill at 6pm to share information on pharmacokenetically guided dosing using Area Under the Curve rather than traditional BSA dosing.  Area Under the Curve is a much more personalized and efficacious way to dose patients and the process is now commercially available through Myriad Genetics.  Studies have shown very little correlation between BSA and 5-FU clearance and studies have indicated greatly elevated levels of efficacy as well as reduced toxicity in patient dosed in this manner.  There has been a change of speaker from a flyer previously distributed noting Dr. Edward Kaplan as the speaker.  Dr. Kaplan had a conflict with this date.  If you would like to attend, please RSVP to 417-269-4520 by August 18, 2009, or email debbie.cane@coxhealth.com