A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
OBJECTIVES:
Primary
- Determine the antitumor activity of topotecan, in terms of frequency and duration of
tumor response, in patients with recurrent platinum-sensitive ovarian epithelial,
fallopian tube, or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- Determine the duration of progression-free survival and overall survival in patients
treated with these regimens.
- Determine the effects of prognostic variables (i.e., initial performance status, age,
and mucinous or clear cell histology) in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued
for this study within 15-30 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response
No
Thomas J. Herzog, MD
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
CDR0000434848
NCT00114166
January 2005
Name | Location |
---|---|
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Tufts-NEMC Cancer Center | Boston, Massachusetts 02111 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Harrington Cancer Center | Amarillo, Texas 79106 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Jersey Shore Cancer Center at Jersey Shore University Medical Center | Neptune, New Jersey 07754-0397 |