A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix
OBJECTIVES:
- Determine the antitumor activity of capecitabine in patients with persistent or
recurrent non-squamous cell carcinoma of the cervix who have failed higher priority
treatment protocols.
- Determine the nature and degree of toxicity of this drug in these patients.
- Determine whether the mRNA tumor expression levels of thymidylate synthase (TS),
dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) at baseline are
potential predictors of clinical outcomes (response and survival) in patients treated
with this drug.
- Determine whether the serum level of TP is a potential prognostic indicator of clinical
outcomes (response and survival) in patients treated with this drug.
- Determine whether the TS promoter polymorphism in peripheral blood is a potential
prognostic indicator of clinical outcomes (response and survival) in patients treated
with this drug.
- Determine the associations among the various measures of TS, DPD, and TP and clinical
outcomes (response and survival) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 15-37 patients will be accrued for this study within
approximately 5-12 months.
Interventional
Primary Purpose: Treatment
Katherine Y. Look, MD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
CDR0000069384
NCT00039442
June 2002
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
Women's Cancer Center - Los Gatos | Los Gatos, California 95032 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Evanston | Evanston, Illinois 60201 |
Hinsdale, Illinois 60521 | |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Southeast Gynecologic Oncology Associates | Knoxville, Tennessee 37917 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
University of Texas M.D. Anderson CCOP Research Base | Houston, Texas 77030-4009 |