Topotecan in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer



Status:Terminated
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 120
Updated:4/17/2018
Start Date:February 2000

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Phase II Evaluation of Three-Day Topotecan (NSC 609699) in Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients who have
recurrent ovarian epithelial or primary peritoneal cancer.

OBJECTIVES: I. Determine the antitumor activity of topotecan in patients with recurrent
platinum sensitive ovarian epithelial or primary peritoneal cancer. II. Determine the nature
and degree of toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-3. Treatment continues every
3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed
every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.

DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial or primary
peritoneal carcinoma Bidimensionally measurable disease (ascites and pleural effusions not
considered measurable) Platinum sensitive (defined as treatment free interval following
response to platinum of greater than 6 months) One prior platinum based chemotherapy
regimen for management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound required

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) SGOT and alkaline phosphatase no greater that 2.5 times ULN Renal: Creatinine
no greater than 1.5 times ULN Other: No active infection requiring antibiotics No
neuropathy greater than grade 1 Not pregnant Negative pregnancy test Fertile patients must
use effective contraception No prior malignancy within past 5 years except nonmelanoma skin
cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic or
immunologic agents Chemotherapy: See Disease Characteristics Recovered from prior
chemotherapy Patients with no prior paclitaxel therapy may receive second regimen that
includes paclitaxel No other prior or concurrent cytotoxic chemotherapy for recurrent or
persistent disease, including retreatment with initial chemotherapy regimens No prior
topotecan Endocrine therapy: At least one week since prior hormonal therapy for malignant
tumor Prior and concurrent hormone replacement therapy allowed Radiotherapy: No prior or
concurrent radiotherapy to target sites No prior radiotherapy to greater than 25% of bone
marrow Recovered from prior radiotherapy Surgery: Recovered from prior surgery Other: No
prior cancer treatment that contraindicates study
We found this trial at
74
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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100 Nicolls Rd
Stony Brook, New York 11790
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Ann Arbor, Michigan 48106
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Atlanta, Georgia 30322
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Baltimore, Maryland 21231
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7700 Old Branch Avenue
Bethesda, Maryland 20892
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9000 Rockville Pike
Bethesda, Maryland 20892
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Billings, Montana 59101
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Boston, Massachusetts 02111
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlottesville, Virginia 22908
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Cleveland, Ohio 44106
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Cleveland, Ohio 44195
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Columbia, Missouri 65203
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Dallas, Texas 75235
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Decatur, Illinois 62526
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Denver, Colorado 80010
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
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Evanston, Illinois 60201
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Hershey, Pennsylvania 17033
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Honolulu, Hawaii 96813
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kansas City, Missouri 64131
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4503 M Street
Keesler Air Force Base, Mississippi 39534
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99 University Avenue
Kingston, Ontario K7L 3N6
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Memphis, Tennessee 38117
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Minneapolis, Minnesota 55455
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73190
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Orange, California 92868
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19104
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111 S 11th St,
Philadelphia, Pennsylvania 19107
(877) 503-8350
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Philadelphia, Pennsylvania 19111
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Phoenix, Arizona 85006
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Portland, Oregon 97225
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Rochester, New York 14642
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Spartanburg, South Carolina 29303
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
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Tacoma, Washington 98415
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Temple, Texas 76508
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3700 O Street Northwest
Washington, District of Columbia 20007
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6900 Georgia Ave NW
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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Winston-Salem, North Carolina 27103
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Wynnewood, Pennsylvania 19096
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