|NCI and 10 Other Institutions Launch Ovarian Cancer Clinical
The National Cancer Institute (NCI), part of the National Institutes of Health
(NIH), is leading a clinical trial designed to build a repository of blood samples
in order to develop an accurate means of detecting ovarian cancer soon after
the disease returns. Researchers will collect a series of blood samples from
women with advanced-stage ovarian cancer who show no signs of cancer after completing
their first program of chemotherapy for ovarian cancer.
According to study lead Elise Kohn, M.D., Center for Cancer Research, NCI, ďIf
we can harness all of the protein information in our patientís samples, we may
have a strong lead on how to detect ovarian cancer at an early stage when it
can be most effectively treated. CA-125 (a test for a protein that is detectable
in 80 percent of advanced stage patients with epithelial ovarian cancer) is currently
the only approved test to see if ovarian cancer has returned, but it is not able
to reliably diagnose women who have no signs of ovarian cancer.Ē The scientistsí long-term
goal is to make a test that can predict the presence of early stage ovarian cancer
using new technology that examines blood proteins.
Advanced-stage ovarian cancer has a high likelihood of returning within three
years of initial treatment even when there are no signs of cancer being present.
Current tests, such as CA-125 and transvaginal ultrasound, do not have good ability
to predict whether cancer will return or not or for finding it in the first place.
New biomarkers, such as those found in blood, are urgently needed.
The trial will enroll 400 women over 24 months. Researchers are looking for
women who have advanced-stage ovarian cancer, have completed their initial chemotherapy
within 9 weeks of starting this trial, and show no evidence of cancer following
completion of their first treatment program for which they received drugs such
as carboplatin or cisplatin with paclitaxel, or docetaxel. The women will have
a physical exam and routine laboratory tests performed every three months and
a CT scan of the abdomen and pelvis (plus chest if indicated) every six months.
Research samples will be frozen to create a repository for analysis of blood
proteins. The study will also compare the blood protein test that is developed
with CA-125 to see if it is better at predicting return of cancer than CA-125.
Additional blood samples will be stored to create a repository so that other
promising blood tests for ovarian cancer may be studied.
ďA pilot study launched in 2000 gave us a better understanding of the complexities
of protein analysis and reinforced the importance of collecting and analyzing
a large number of blood samples and their protein patterns. After carefully analyzing
our processes and procedures during that pilot study, we now have the opportunity
to incorporate those advances and to gather a larger patient pool, expand our
partnerships, and make sure that we do not create false-positive results for
our patients,Ē said Kohn. The trialís leaders note that their goal is to create
the best, most accurate, validated test so patients can have a high level of
confidence when their results come back.
Ovarian cancer accounts for approximately four percent of all womenís cancers
and is the fourth leading cause of cancer-related death among women in the United
States, with close to 16,000 women expected to die of the disease in 2005.
For more information or to enroll in the trial at NCIís Bethesda, Maryland location,
please call 1-888-NCI-1937 (1-888-624-1937). Women who are not eligible for this
trial but are interested in joining a different clinical trial are invited to
contact NCI at 1-800-4-CANCER or go to www.cancer.gov/clinicaltrials.
The first site opening for this trial is at NCIís clinical facility on the NIH
campus in Bethesda, Maryland. Ten other sites will begin enrolling patients later
in 2005 or in 2006. The other participating institutions include:
- Fred Hutchinson Cancer Research Center and the University of Washington,
- Cedars Sinai Medical Center, Los Angeles, Calif.
- University of Alabama at Birmingham
- Duke University Medical Center, Durham, N.C.
- Fox Chase Cancer Center, Philadelphia, Pa.
- University of Texas MD Anderson Cancer Center, Houston, Texas
- Massachusetts General Hospital, Boston, Mass.
- Northwestern Memorial Hospital, Chicago, Ill.
- Evanston Northwestern University Hospital, Evanston, Ill.
- New York University School of Medicine, New York, N.Y.
For more information about cancer, visit the NCI Web site at http://www.cancer.gov or
call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
The National Institutes of Health (NIH) — The Nation's Medical Research
Agency — includes 27 Institutes and Centers and is a component of
the U. S. Department of Health and Human Services. It is the primary Federal
agency for conducting and supporting basic, clinical, and translational medical
research, and it investigates the causes, treatments, and cures for both common
and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.