Ovarian Cancer Clinical Trial

Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

571

Study ID:

NCT00003644

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 138 Locations for this study

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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Banner Thunderbird Medical Center
Glendale Arizona, 85306, United States
Banner Good Samaritan Medical Center
Phoenix Arizona, 85006, United States
CCOP - Western Regional, Arizona
Phoenix Arizona, 85006, United States
Highlands Oncology Group - Fayetteville
Fayetteville Arkansas, 72703, United States
Washington Regional Medical Center
Fayetteville Arkansas, 72703, United States
Alta Bates Comprehensive Cancer Center
Berkeley California, 94704, United States
Peninsula Medical Center
Burlingame California, 94010, United States
Marin Cancer Institute at Marin General Hospital
Greenbrae California, 94904, United States
Sutter Health - Western Division Cancer Research Group
Greenbrae California, 94904, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach California, 90801, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles California, 90027, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles California, 90095, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange California, 92868, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
California Pacific Medical Center - California Campus
San Francisco California, 94118, United States
Torrance Memorial Medical Center
Torrance California, 90509, United States
Colorado Gynecologic Oncology Group P.C.
Aurora Colorado, 80010, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford Connecticut, 06102, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando Florida, 32803, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa Florida, 33612, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston Illinois, 60201, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Howard Community Hospital at Howard Regional Health System
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Cancer Resource Center at King's Daughters Medical Center
Ashland Kentucky, 41101, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
James Graham Brown Cancer Center at University of Louisville
Louisville Kentucky, 40202, United States
Tulane Cancer Center
Alexandria Louisiana, 71315, United States
Woman's Hospital
Baton Rouge Louisiana, 70815, United States
Greater Baltimore Medical Center Cancer Center
Baltimore Maryland, 21204, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Tufts-NEMC Cancer Center
Boston Massachusetts, 02111, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield Massachusetts, 01199, United States
UMASS Memorial Cancer Center - University Campus
Worcester Massachusetts, 01655, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph Michigan, 49085, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
Minneapolis Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha Nebraska, 68114, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton New Jersey, 08053, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees New Jersey, 08043, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque New Mexico, 87131, United States
SUNY Downstate Medical Center
Brooklyn New York, 11203, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Cancer Institute at New York University Medical Center
New York New York, 10016, United States
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro North Carolina, 27403, United States
Gynecologic Oncology Network
Greenville North Carolina, 27834, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville North Carolina, 27835, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst North Carolina, 28374, United States
Annie Penn Cancer Center
Reidsville North Carolina, 27320, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Cancer Care Center at Medcenter One Hospital
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center
Bismarck North Dakota, 58502, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton Ohio, 44710, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights Ohio, 44124, United States
Lake/University Ireland Cancer Center
Mentor Ohio, 44060, United States
OU Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Oregon Health & Science University Cancer Institute
Portland Oregon, 97239, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown Pennsylvania, 18105, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia Pennsylvania, 19140, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Geisinger Medical Group - Scenery Park
State College Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville Tennessee, 37901, United States
Baptist Centers for Cancer Care
Memphis Tennessee, 38120, United States
Harrington Cancer Center
Amarillo Texas, 79106, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States
Bon Secours Cancer Institute at St. Mary's Hospital
Richmond Virginia, 23226, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Carilion Gynecologic Oncology Associates
Roanoke Virginia, 24014, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
Marshfield Clinic - Indianhead Center
Rice Lake Wisconsin, 54868, United States
Kagoshima City Hospital
Kagoshima City, Kagoshima , 892-8, Japan
Kobe Medical Center
Kobe , 654-0, Japan
Shikoku Cancer Center
Matsuyama , 790-0, Japan
National Kyushu Cancer Center
Minami-ku , 811 1, Japan
Tohoku University Graduate School of Medicine
Sendai , , Japan
National Cancer Center Hospital
Tokyo , 104 0, Japan
Tottori University Hospital
Tottori , 680-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

571

Study ID:

NCT00003644

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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