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

Condition(s) targeted: Ovarian Cancer

Intervention: carboplatin (Drug); paclitaxel (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Gynecologic Oncology Group

Official(s) and/or principal investigator(s):
Robert S. Mannel, MD, Study Chair, Affiliation: University of Oklahoma College of Medicine
David S. Alberts, MD, Study Chair, Affiliation: University of Arizona

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.

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 design: Treatment, Randomized, Active Control

Primary outcome:

Recurrence-free interval

Overall survival

Frequency and severity of adverse events

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Kagoshima City Hospital, Kagoshima City, Kagoshima 892-8580, Japan

Kobe Medical Center, Kobe 654-0155, Japan

National Cancer Center Hospital, Tokyo 104 0045, Japan

National Kyushu Cancer Center, Minami-ku 811 1395, Japan

Shikoku Cancer Center, Matsuyama 790-0007, Japan

Tohoku University Graduate School of Medicine, Sendai, Japan

Tottori University Hospital, Tottori 680-8550, Japan

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294, United States

Banner Good Samaritan Medical Center, Phoenix, Arizona 85006, United States

Banner Thunderbird Medical Center, Glendale, Arizona 85306, 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

California Pacific Medical Center - California Campus, San Francisco, California 94118, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California 92868, United States

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 90095-1781, United States

Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California 90027, United States

Marin Cancer Institute at Marin General Hospital, Greenbrae, California 94904, United States

Peninsula Medical Center, Burlingame, California 94010, 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

Torrance Memorial Medical Center, Torrance, California 90509, United States

University of California Davis Cancer Center, Sacramento, California 95817, United States

Colorado Gynecologic Oncology Group P.C., Aurora, Colorado 80010, United States

McKee Medical Center, Loveland, Colorado 80539, United States

North Colorado Medical Center, Greeley, Colorado 80631, United States

Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford, Connecticut 06102-5037, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida 32803-1273, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida 33612-9497, United States

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida 33136, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois 60201-1781, United States

Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

University of Illinois Cancer Center, Chicago, Illinois 60612-7243, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Howard Community Hospital at Howard Regional Health System, Kokomo, Indiana 46904, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, 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

Associates in Womens Health, PA - North Review, Wichita, Kansas 67203, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, 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

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, 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

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States

CCOP - Wichita, Wichita, Kansas 67214, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

Southwest Medical Center, Liberal, Kansas 67901, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

Cancer Resource Center at King's Daughters Medical Center, Ashland, Kentucky 41101, United States

James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky 40202, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky 40536-0293, United States

Tulane Cancer Center, Alexandria, Louisiana 71315-3198, 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 21231-2410, United States

Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts 01199, United States

Tufts-NEMC Cancer Center, Boston, Massachusetts 02111, United States

UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts 01655, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Borgess Medical Center, Kalamazooaa, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, St. Joseph, Michigan 49085, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, 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

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri 65807, United States

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri 63110, United States

St. John's Regional Health Center, Springfield, Missouri 65804, 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 03756-0002, 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

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey 08053, United States

University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico 87131-5636, United States

NYU Cancer Institute at New York University Medical Center, New York, New York 10016, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Stony Brook University Cancer Center, Stony Brook, New York 11794-8174, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Annie Penn Cancer Center, Reidsville, North Carolina 27320, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina 28374, United States

Gynecologic Oncology Network, Greenville, North Carolina 27834, United States

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina 27835-6028, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States

Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina 27403-1198, United States

Randolph Hospital, Asheboro, North Carolina 27203-5400, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, 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

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio 43210-1240, United States

Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio 44710-1799, United States

Case Comprehensive Cancer Center, Cleveland, Ohio 44106, United States

Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio 44124, United States

Lake/University Ireland Cancer Center, Mentor, Ohio 44060, United States

McDowell Cancer Center at Akron General Medical Center, Akron, Ohio 44307, United States

MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States

OU Cancer Institute, Oklahoma City, Oklahoma 73104, United States

Oregon Health & Science University Cancer Institute, Portland, Oregon 97239-3098, United States

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania 19104-4283, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania 19111-2497, United States

Fox Chase Cancer Center CCOP Research Base, Philadelphia, Pennsylvania 19140, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States

Geisinger Medical Center, Danville, Pennsylvania 17822-0001, United States

Geisinger Medical Group - Scenery Park, State College, Pennsylvania 16801, United States

Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania 18105, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania 19001, United States

UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania 15213, United States

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota 57117-5039, United States

Baptist Centers for Cancer Care, Memphis, Tennessee 38120, United States

Baptist Regional Cancer Center at Baptist Hospital of East Tennessee, Knoxville, Tennessee 37901, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234, 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

University of Texas Medical Branch, Galveston, Texas 77555-0361, 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

Carilion Gynecologic Oncology Associates, Roanoke, Virginia 24014, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 1998
Last updated: May 23, 2008