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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003644
• Other study ID #: GOG-0175
• Secondary ID: NCI-2012-02291SW
• Status: Completed
• Phase: Phase 3
• Start date: October 1998

Study information

• Verified date: March 2016
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• carboplatin

• paclitaxel

Locations

Country	Name	City	State
Japan	Kagoshima City Hospital	Kagoshima City, Kagoshima
Japan	Kobe Medical Center	Kobe
Japan	Shikoku Cancer Center	Matsuyama
Japan	National Kyushu Cancer Center	Minami-ku
Japan	Tohoku University Graduate School of Medicine	Sendai
Japan	National Cancer Center Hospital	Tokyo
Japan	Tottori University Hospital	Tottori
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Tulane Cancer Center	Alexandria	Louisiana
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Harrington Cancer Center	Amarillo	Texas
United States	Randolph Hospital	Asheboro	North Carolina
United States	Cancer Resource Center at King's Daughters Medical Center	Ashland	Kentucky
United States	Colorado Gynecologic Oncology Group P.C.	Aurora	Colorado
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	Tufts-NEMC Cancer Center	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Peninsula Medical Center	Burlingame	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Highlands Oncology Group - Fayetteville	Fayetteville	Arkansas
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	Banner Thunderbird Medical Center	Glendale	Arizona
United States	North Colorado Medical Center	Greeley	Colorado
United States	Marin Cancer Institute at Marin General Hospital	Greenbrae	California
United States	Sutter Health - Western Division Cancer Research Group	Greenbrae	California
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Gynecologic Oncology Network	Greenville	North Carolina
United States	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina
United States	Helen and Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Baptist Regional Cancer Center at Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Howard Community Hospital at Howard Regional Health System	Kokomo	Indiana
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Southwest Medical Center	Liberal	Kansas
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	Todd Cancer Institute at Long Beach Memorial Medical Center	Long Beach	California
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Baptist Centers for Cancer Care	Memphis	Tennessee
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	University of Minnesota Medical Center & Children's Hospital - Fairview	Minneapolis	Minnesota
United States	NYU Cancer Institute at New York University Medical Center	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	OU Cancer Institute	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center CCOP Research Base	Philadelphia	Pennsylvania
United States	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University Cancer Institute	Portland	Oregon
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin
United States	Bon Secours Cancer Institute at St. Mary's Hospital	Richmond	Virginia
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Carilion Gynecologic Oncology Associates	Roanoke	Virginia
United States	University of California Davis Cancer Center	Sacramento	California
United States	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	Saint Joseph	Michigan
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	Baystate Regional Cancer Program at D'Amour Center for Cancer Care	Springfield	Massachusetts
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Geisinger Medical Group - Scenery Park	State College	Pennsylvania
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	Torrance Memorial Medical Center	Torrance	California
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI), Southwest Oncology Group

Countries where clinical trial is conducted

United States,  Japan, 

References & 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 × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	The percent of participants with disease recurrence within 5 years	Up to 5 years
Primary	Overall Survival	Number of deaths during study and follow up.	up to 96 months
Primary	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