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
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Female
Ovarian Cancer
Female
Ovarian Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Recurrence-free interval
Safety Issue:
No
Principal Investigator
Robert S. Mannel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Oklahoma College of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000066732
NCT ID:
NCT00003644
Start Date:
October 1998
Completion Date:
Related Keywords:
- Ovarian Cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- ovarian undifferentiated adenocarcinoma
- ovarian mixed epithelial carcinoma
- ovarian serous cystadenocarcinoma
- ovarian mucinous cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- Brenner tumor
- Ovarian Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
| Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Tufts-NEMC Cancer Center | Boston, Massachusetts 02111 |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
| Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Gynecologic Oncology Network | Greenville, North Carolina 27858 |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
| Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
| Torrance Memorial Medical Center | Torrance, California 90505 |
| Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |
| Banner Thunderbird Medical Center | Phoenix, Arizona 85306 |
| North Colorado Medical Center | Greeley, Colorado 80631 |
| McKee Medical Center | Loveland, Colorado 80539 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
| Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Todd Cancer Institute at Long Beach Memorial Medical Center | Long Beach, California 90801 |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| Baptist Centers for Cancer Care | Memphis, Tennessee 38120 |
| Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Peninsula Medical Center | Burlingame, California 94010 |
| Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
| Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
| California Pacific Medical Center - California Campus | San Francisco, California 94118 |
| Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
| Bismarck Cancer Center | Bismarck, North Dakota 58501 |
| St. Alexius Medical Center | Bismarck, North Dakota 58502 |
| Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee 37901 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| Tulane Cancer Center | New Orleans, Louisiana 70112 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| Randolph Hospital | Asheboro, North Carolina 27203 |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
| Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
| Highlands Oncology Group - Fayetteville | Fayetteville, Arkansas 72703 |
| Washington Regional Medical Center | Fayetteville, Arkansas 72703 |
| Colorado Gynecologic Oncology Group P.C. | Aurora, Colorado 80010 |
| Cancer Resource Center at King's Daughters Medical Center | Ashland, Kentucky 41101 |
| Woman's Hospital | Baton Rouge, Louisiana 70815 |
| University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis, Minnesota 55455 |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| OU Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Oregon Health & Science University Cancer Institute | Portland, Oregon 97239-3098 |
| Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
| Bon Secours Cancer Institute at St. Mary's Hospital | Richmond, Virginia 23226 |
