Cancer Care

The following clinical trials are in progress for cancer care. If you are interested in participating in a trial, please discuss the specific trial with your physician and ask him to contact the Local PI on your behalf.

1.“AVASTIN” --- A data collection study on how patients who have colorectal cancer do while receiving Avastin in combination with other chemotherapy drugs. The study will also evaluate the frequency of complications associated with Avastin and chemotherapy.
Industry sponsored: Genentech, Inc., South San Francisco, CA
Local PI: George Sanders, MD
Local IRB approval: April 2004
Status: The study is closed to enrollment

2.“BRE 37” --- A study comparing two different treatment combinations of three different chemotherapy drugs: Adriamycin (or Rubex), Cytoxan, and Taxol as post-surgical treatment for breast cancer women with a high risk of relapse, to determine which combination is most effective and tolerable.
Foundation sponsored: Sarah Cannon Cancer Institute, Nashville, TN
Local PI: George Sanders, MD
Local IRB approval: February 2000
Status: The study is closed to enrollment

3.“CCCWFU #60A02 (Fruit/Vegetable Extract)” --- A study to determine what effects fruit and vegetable extracts have on patients with previously diagnosed head and neck cancers, whether these effects are influenced by other factors, such as the stage of the tumor, tobacco/alcohol use or depression, and to determine whether these extracts can increase the antioxidant levels in the blood.
Sponsor: Comprehensive Cancer Center of Wake Forest University, (CCCWFU)
Local PI: Bart Frizzell, MD
Local IRB approval: December 2004
Status: The study is open to enrollment

4.“CCCWFU #97100 (DONEPEZIL v. GINGKO)” --- A study originally created to determine if either the drug Aricept, (donepezil), or the herbal supplement gingko biloba, would reduce some of the side effects associated with radiation therapy in brain tumor patients. The donepezil portion of the study has been completed. The study related to gingko biloba continues.
Sponsor: Comprehensive Cancer Center of Wake Forest University, (CCCWFU)
Local PI: Bart Frizzell, MD
Local IRB approved: February 2002
Status: The study is closed to enrollment

5.“CCCWFU #97102 (Oxandrin v. Megace)” --- A study comparing the effects, (good and bad) of Oxandrolone (Oxandrin), and Megestrol acetate (Megace), on weight gain, weight loss, body composition and quality of life in patients with solid tumors receiving chemotherapy.
Sponsor: Comprehensive Cancer Center of Wake Forest University, (CCCWFU)
Local PI: Bart Frizzell, MD
Local IRB approval: April 2004
Status: The study is open to enrollment

6.“CCCWFU #97202 (Co-Q10)” --- A study to determine if taking oral coenzyme Q10, (Co-Q10), and Vitamin E will relieve self-reported cancer treatment-related fatigue in female patients with breast cancer receiving chemotherapy.
Sponsor: Comprehensive Cancer Center of Wake Forest University, (CCCWFU)
Local PI: Bart Frizzell, MD
Local IRB approval: June 2005
Status: The study is open to enrollment

7.“CCCWFU #97301 (STRENGTH)” --- A study comparing the three different diets and/or exercise programs, to determine which is the most effective in preventing body composition changes, in patients who are receiving post-surgical chemotherapy for breast cancer.
Sponsor: Comprehensive Cancer Center of Wake Forest University, (CCCWFU)
Local PI: George Sanders, MD
Local IRB approval: October 2002
Status: The study is closed to enrollment

8.“CTSU MA.27” --- A study to compare the ability of Aromsin and Armidex to prevent the recurrence of breast cancer and to compare their side effects on post-menopausal women with receptor positive primary breast cancer.
Sponsor: National Cancer Institute of Canada
Local PI: George Sanders, MD
Local IRB Approval: September 2005
Status: The study is open to enrollment

9.“HLMCC 0501” – A quality of life study to learn more about the effectiveness of certain kinds of stress management therapy techniques for patients undergoing chemotherapy.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida
Local PI: George Sanders, MD
Local IRB Approval: March 2007
Status: The study is open to enrollment

10.“LORHAN Registry” – A data collection study, (a registry), of information about head and neck cancer patients who are receiving radiation therapy and/or drug therapy as a treatment for the disease.
Sponsor: ImClone Systems Incorporated, Branchburg, NJ
Local PI: Bart Frizzell, MD
Local IRB Approval: March 2007
Status: The study is open to enrollment

11.“MAMMOSITE” --- A data collection study designed to compile information on the use of Mammosite RTS, a FDA approved device designed to deliver internal radiation in post-lumpectomy patients.
Industry sponsored: Proxima Therapeutics, Alpharette, GA
Local PI: Bart Frizzell, MD
Local IRB approval: October 2002
Status: The study is open to enrollment

12.“NAFTA” --- A study comparing the chemotherapy drugs Fareston and Tamoxifen as post-surgical treatment for localized breast cancer patients, to determine which drug is more effective and tolerable.
University sponsored: The University of Louisville, Louisville, KY
Local PI: George Sanders, MD
Local IRB approval: February 1999
Status: The study is closed to enrollment

13.“NSABP B-39 (Whole Breast Irradiation versus Partial Breast Irradiation)” --- A study comparing these two types of radiation therapy in women with Stage 0, I, or II breast cancers.
Sponsor: The National Surgical Adjuvant Breast Project (NSABP), Pittsburgh, PA
Local PI: Bart Frizzell, MD
Local IRB approval: May 2005
Status: The study is open to enrollment, with the exception of certain low-risk groups

14.“PACCT-1: The TAILORx Trial” --- A study using a gene test to score certain types of breast cancer, to determine whether patients with a score in one range benefit from chemotherapy and whether other patients with a lower score have a very low risk of recurrence with hormonal therapy alone.
Sponsors: Eastern Cooperative Oncology Group, (ECOG) and the National Cancer Institute Cancer Trials Support Unit, (CTSU).
Local PI: George Sanders, MD
Local IRB Approval: October 2006
Status: The study is open to enrollment

15.“RTOG 0117” --- A study to determine the highest dose of radiation that can be given with the drug combination of paclitaxel and carboplatin without causing severe side effects, for patients with inoperable, non-small cell lung cancer.
Sponsor: Radiation Therapy Oncology Group, (RTOG) of the American College of Radiology, and the Comprehensive Cancer Center of Wake Forest University, (CCCWFU)
Local PI: Bart Frizzell, MD
Local IRB approval: November 2004
Status: The study is open to enrollment

16.“RTOG 0521” – A study to determine the effectiveness of adding chemotherapy to the standard treatment of radiation and hormonal therapy in patients with localized, high-risk prostate cancer.
Sponsor: Radiation Therapy Oncology Group, (RTOG) of the American College of Radiology, and the Comprehensive Cancer Center of Wake Forest University, (CCCWFU)
Local PI: Bart Frizzell, MD
Local IRB approval: March 2007
Status: The study is open to enrollment

17.“SWOG – S0307” --- A study to determine if adding one of three different bisphosphonate drugs to hormonal therapy or chemotherapy with help prevent the spread of breast cancer to bones or other parts of the body.
Sponsor: Southwest Oncology Group
Local PI: George Sanders, MD
Local IRB approval: October 2006
Status: The study is open to enrollment

18.“SWOG – S0424” --- An observational study to determine why women are more likely to be diagnosed with certain types of lung caner than men are, and to see if factors other than smoking may put women at higher risk of lung cancer than men.
Sponsor: Southwest Oncology Group
Local PI: Bart Frizzell, MD
Local IRB approval: May 2006
Status: The study is open to enrollment

19.“URCC 3905” --- A study to determine if a four-week Hatha yoga program provided in a community-based setting two times a week for seventy-five minutes per session can provide improvement in sleep quality for cancer survivors.
University sponsored: University of Rochester Cancer Center CCOP Research Base, Rochester, NY
Local PI: George Sanders, MD
Local IRB approval: January 2007
Status: The study is open to enrollment