Spots Global Cancer Trial Database for Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
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Trial Identification
Brief Title: Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
Official Title: A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma
Study ID: NCT00003644
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. 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.
Detailed Description: OBJECTIVES: * 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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, 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
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, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, 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, Minami-ku, , Japan
Tohoku University Graduate School of Medicine, Sendai, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Tottori University Hospital, Tottori, , Japan
Contact Details
Name: Robert S. Mannel, MD
Affiliation: University of Oklahoma College of Medicine
Role: STUDY_CHAIR
Name: David S. Alberts, MD
Affiliation: University of Arizona
Role: STUDY_CHAIR
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