Paclitaxel in Treating Patients With Ovarian Stromal Cancer



Status:Completed
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:8/25/2017
Start Date:November 20, 2000
End Date:July 16, 2016

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Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy

This phase II trial studies the effectiveness of paclitaxel in treating patients who have
ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells
from dividing so they stop growing or die.

PRIMARY OBJECTIVES:

I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line
chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.

II. To evaluate the value of inhibin for predicting response.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues
every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, then every 6 months for three years, and
then annually thereafter.

Inclusion Criteria:

- Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell
tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma],
steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex
cord tumor with annular tubules)

- Patients must have recurrent stromal tumor having received no more than one prior
chemotherapy regimen

- Patients must have measurable disease as defined by Gynecological Oncology Group (GOG)
Response Evaluation Criteria in Solid Tumors (RECIST) criteria

- White blood count equal to or greater than 3000/mcl

- Granulocyte count equal to or greater than 1500/mcl

- Platelet count equal to or greater than 100,000/mcl

- Creatinine equal to or less than 2.0 mg%

- Bilirubin less than or equal to 1.5 times normal

- Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal

- Patients with a GOG performance grade of 0, 1 or 2

- Patients of child bearing potential must have a negative pregnancy test and must agree
to practice an effective means of birth control

- Patients who have met the pre-entry requirements as specified

- Patients must have signed an approved informed consent and Health Insurance
Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

- Patients with GOG performance grade of 3 or 4

- Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have
had any evidence of disease within the last 5 years or whose prior malignancy
treatment contraindicates the current protocol therapy

- Patients having received more than one prior chemotherapy regimen

- Patients amenable to cure by surgery

- Patients with prior radiation except for those whose recurrent disease is outside the
radiation port
We found this trial at
86
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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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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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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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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Allentown, Pennsylvania 18103
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Auburn, Washington 98001
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70816
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500 Fisher Street
Biloxi, Mississippi 39534
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
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Centralia, Washington 98531
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28204
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Columbus, Ohio 43222
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Elkton, Maryland 21921
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Federal Way, Washington 98003
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Glendale, Arizona 85306
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Indianapolis, Indiana 46260
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Knoxville, Tennessee 37917
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Lackland Air Force Base, Texas 78236
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Lakewood, Washington 98499
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3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
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424 Savannah Rd
Lewes, Delaware 19958
(302) 645-3300
Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
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Los Angeles, California 90095
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Los Gatos, California 95032
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Louisville, Kentucky 40202
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2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
McKee Medical Center Through the years, McKee has led the way in health care innovation....
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Mayfield Heights, Ohio 44124
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9485 Mentor Ave
Mentor, Ohio 44060
(440) 205-5755
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Michigan City, Indiana 46360
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Morgantown, West Virginia 26505
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Mountain View, California 94040
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Neptune City, New Jersey 07753
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100 Grand St
New Britain, Connecticut 06050
(860) 224-5011
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Olympia, Washington 98506
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Olympia, Washington 98507
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
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Phoenix, Arizona 85006
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Puyallup, Washington 98372
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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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San Francisco, California 94115
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Savannah, Georgia 31404
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Scottsdale, Arizona 85259
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Sendai, Aoba-ku 98085
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Tacoma, Washington 98405
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1825 Eastchester Road
The Bronx, New York 10461
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111 East 210th Street
The Bronx, New York 10467
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Winston-Salem, North Carolina 27103
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Winston-Salem, North Carolina 27103
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Winston-Salem, North Carolina 27103
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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