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.
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.
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
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There are 138 Locations for this study
Birmingham Alabama, 35294, United States
Glendale Arizona, 85306, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85006, United States
Fayetteville Arkansas, 72703, United States
Fayetteville Arkansas, 72703, United States
Berkeley California, 94704, United States
Burlingame California, 94010, United States
Greenbrae California, 94904, United States
Greenbrae California, 94904, United States
Long Beach California, 90801, United States
Los Angeles California, 90027, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
San Francisco California, 94118, United States
Torrance California, 90509, United States
Aurora Colorado, 80010, United States
Greeley Colorado, 80631, United States
Loveland Colorado, 80539, United States
Hartford Connecticut, 06102, United States
Newark Delaware, 19713, United States
Miami Florida, 33136, United States
Orlando Florida, 32803, United States
Tampa Florida, 33612, United States
Savannah Georgia, 31403, United States
Aurora Illinois, 60507, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Hinsdale Illinois, 60521, United States
Joliet Illinois, 60435, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Elkhart Indiana, 46515, United States
Indianapolis Indiana, 46202, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Iowa City Iowa, 52242, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kansas City Kansas, 66160, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Ashland Kentucky, 41101, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Alexandria Louisiana, 71315, United States
Baton Rouge Louisiana, 70815, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Springfield Massachusetts, 01199, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Saint Joseph Michigan, 49085, United States
Minneapolis Minnesota, 55455, United States
Jackson Mississippi, 39216, United States
Columbia Missouri, 65203, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68114, United States
Lebanon New Hampshire, 03756, United States
Marlton New Jersey, 08053, United States
Voorhees New Jersey, 08043, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87131, United States
Brooklyn New York, 11203, United States
Buffalo New York, 14263, United States
New York New York, 10016, United States
Stony Brook New York, 11794, United States
Asheboro North Carolina, 27203, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28232, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27403, United States
Greenville North Carolina, 27834, United States
Greenville North Carolina, 27835, United States
Pinehurst North Carolina, 28374, United States
Reidsville North Carolina, 27320, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Akron Ohio, 44307, United States
Canton Ohio, 44710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Abington Pennsylvania, 19001, United States
Allentown Pennsylvania, 18105, United States
Danville Pennsylvania, 17822, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15213, United States
Reading Pennsylvania, 19612, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Sioux Falls South Dakota, 57117, United States
Knoxville Tennessee, 37901, United States
Memphis Tennessee, 38120, United States
Amarillo Texas, 79106, United States
Dallas Texas, 75390, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Burlington Vermont, 05401, United States
Richmond Virginia, 23226, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24014, United States
Marshfield Wisconsin, 54449, United States
Rice Lake Wisconsin, 54868, United States
Kagoshima City, Kagoshima , 892-8, Japan
Kobe , 654-0, Japan
Matsuyama , 790-0, Japan
Minami-ku , 811 1, Japan
Sendai , , Japan
Tokyo , 104 0, Japan
Tottori , 680-8, Japan
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