Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
NCT ID: NCT00003644
Last Updated: 2019-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
571 participants
INTERVENTIONAL
1998-10-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.
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Detailed Description
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* Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.
* Assess the frequency and severity of toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.
* Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Carboplatin, paclitaxel, low dose paclitaxel
carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
carboplatin
paclitaxel
Carboplatin, paclitaxel
carboplatin, paclitaxel
carboplatin
paclitaxel
Interventions
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carboplatin
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types:
* Serous adenocarcinoma
* Malignant Brenner's tumor
* Mucinous adenocarcinoma
* Endometrioid
* Adenocarcinoma
* Clear cell adenocarcinoma
* Undifferentiated carcinoma
* Transitional cell
* Mixed epithelial carcinoma
* Adenocarcinoma - not otherwise specified
* Meets 1 of the following criteria:
* Stage Ia or Ib, grade 3 or clear cell
* Stage Ic or II, all grades/histologies
* Complete surgical staging
* No tumors of low malignant potential (borderline tumors)
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* GOG 0-3
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times normal
* Alkaline phosphatase no greater than 3 times normal
* SGOT no greater than 3 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Other:
* No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
* No major systemic medical illness expected to affect survival
* Body surface area no greater than 2.0
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Other:
* No prior treatment for this malignancy except surgical staging
* No prior anticancer therapy that would preclude study participation
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Robert S. Mannel, MD
Role: STUDY_CHAIR
University of Oklahoma College of Medicine
David S. Alberts, MD
Role: STUDY_CHAIR
University of Arizona
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Banner Thunderbird Medical Center
Glendale, Arizona, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
Peninsula Medical Center
Burlingame, California, United States
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
California Pacific Medical Center - California Campus
San Francisco, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Colorado Gynecologic Oncology Group P.C.
Aurora, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Cancer Resource Center at King's Daughters Medical Center
Ashland, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Tulane Cancer Center
Alexandria, Louisiana, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Gynecologic Oncology Network
Greenville, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Annie Penn Cancer Center
Reidsville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
OU Cancer Institute
Oklahoma City, Oklahoma, United States
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States
Baptist Centers for Cancer Care
Memphis, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Bon Secours Cancer Institute at St. Mary's Hospital
Richmond, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States
Kagoshima City Hospital
Kagoshima City, Kagoshima, , Japan
Kobe Medical Center
Kobe, , Japan
Shikoku Cancer Center
Matsuyama, , Japan
National Kyushu Cancer Center
Minamiku, , Japan
Tohoku University Graduate School of Medicine
Sendai, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Tottori University Hospital
Tottori, , Japan
Countries
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References
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Mannel RS, Brady MF, Kohn EC, Hanjani P, Hiura M, Lee R, Degeest K, Cohn DE, Monk BJ, Michael H. A randomized phase III trial of IV carboplatin and paclitaxel x 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2011 Jul;122(1):89-94. doi: 10.1016/j.ygyno.2011.03.013. Epub 2011 May 6.
Other Identifiers
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NCI-2012-02291
Identifier Type: -
Identifier Source: secondary_id
SWOG-G0175
Identifier Type: -
Identifier Source: secondary_id
GOG-0175
Identifier Type: -
Identifier Source: org_study_id
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