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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
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