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

NCT00003644 | Completed Phase 3 Results DMC

• 3 other identifiers: GOG-0175NCI-2012-02291SWOG-G0175
• Study Type: interventional
• Target: 571
• Locations: 2 countries
• Sites: 151

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.

Conditions

Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Progression-free Survival

  The percent of participants with disease recurrence within 5 years

  Up to 5 years

• Overall Survival

  Number of deaths during study and follow up.

  up to 96 months

• Number of Participants With Adverse Events Grade 3 or Greater

  Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants

  Throughout study treatment lasting up to 24 weeks

Study Arms (2)

Carboplatin, paclitaxel, low dose paclitaxel

EXPERIMENTAL

carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later

Drug: carboplatin; Drug: paclitaxel

Carboplatin, paclitaxel

ACTIVE COMPARATOR

carboplatin, paclitaxel

Drug: carboplatin; Drug: paclitaxel

Interventions

carboplatin DRUG

Carboplatin, paclitaxel; Carboplatin, paclitaxel, low dose paclitaxel

paclitaxel DRUG

Carboplatin, paclitaxel; Carboplatin, paclitaxel, low dose paclitaxel

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• SWOG Cancer Research Network: collaborator

Study Sites (151)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Banner Thunderbird Medical Center

Glendale, Arizona, 85306, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006, United States

Location

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

Sutter Health - Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

Todd Cancer Institute at Long Beach Memorial Medical Center

Long Beach, California, 90801, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90509, United States

Location

Colorado Gynecologic Oncology Group P.C.

Aurora, Colorado, 80010, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Howard Community Hospital at Howard Regional Health System

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Cancer Resource Center at King's Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane Cancer Center

Alexandria, Louisiana, 71315-3198, United States

Location

Woman's Hospital

Baton Rouge, Louisiana, 70815, United States

Location

Greater Baltimore Medical Center Cancer Center

Baltimore, Maryland, 21204, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Tufts-NEMC Cancer Center

Boston, Massachusetts, 02111, United States

Location

Baystate Regional Cancer Program at D'Amour Center for Cancer Care

Springfield, Massachusetts, 01199, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

University of Minnesota Medical Center & Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Methodist Cancer Center at Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-8174, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203-5400, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, 27403-1198, United States

Location

Gynecologic Oncology Network

Greenville, North Carolina, 27834, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27835-6028, United States

Location

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Annie Penn Cancer Center

Reidsville, North Carolina, 27320, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Cancer Care Center at Medcenter One Hospital

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center

Bismarck, North Dakota, 58502, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710-1799, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

OU Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health & Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Joan Karnell Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Fox Chase Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, 19140, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Baptist Regional Cancer Center at Baptist Hospital of East Tennessee

Knoxville, Tennessee, 37901, United States

Location

Baptist Centers for Cancer Care

Memphis, Tennessee, 38120, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Bon Secours Cancer Institute at St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Carilion Gynecologic Oncology Associates

Roanoke, Virginia, 24014, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Kagoshima City Hospital

Kagoshima City, Kagoshima, 892-8580, Japan

Location

Kobe Medical Center

Kobe, 654-0155, Japan

Location

Shikoku Cancer Center

Matsuyama, 790-0007, Japan

Location

National Kyushu Cancer Center

Minamiku, 811 1395, Japan

Location

Tohoku University Graduate School of Medicine

Sendai, Japan

Location

National Cancer Center Hospital

Tokyo, 104 0045, Japan

Location

Tottori University Hospital

Tottori, 680-8550, Japan

Location

Related Publications (1)

• Mannel RS, Brady MF, Kohn EC, Hanjani P, Hiura M, Lee R, Degeest K, Cohn DE, Monk BJ, Michael H. A randomized phase III trial of IV carboplatin and paclitaxel x 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2011 Jul;122(1):89-94. doi: 10.1016/j.ygyno.2011.03.013. Epub 2011 May 6.

  PMID: 21529904 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Brenner Tumor

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Linda Gedeon, Christopher Purdy on behalf of Mark Brady, PhD
• Organization: NRG Oncology

lgedeon@gogstats.org

(716) 845-1169

Study Officials

• Robert S. Mannel, MD

  University of Oklahoma College of Medicine

  STUDY CHAIR

• David S. Alberts, MD

  University of Arizona

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: October 1, 1998
• Primary Completion: March 1, 2010
• Last Updated: June 4, 2019
• Results First Posted: April 17, 2019

Record last verified: 2016-03

Locations

JP (7); US (144)