Paclitaxel and Cisplatin in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

Last updated: May 24, 2013
Sponsor: Gynecologic Oncology Group
Overall Status: Completed

Phase

3

Condition

Vaginal Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT00002717
CDR0000064554
GOG-0162
  • Ages > 18
  • Female

Study 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 which chemotherapy regimen is more effective for ovarian or peritoneal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel plus cisplatin in treating patients who have residual disease after surgery to remove stage III or stage IV ovarian cancer or primary peritoneal cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer or primary peritoneal cancer Suboptimal residual disease within 6 weeks of laparotomy with maximum resection Stage III residual retroperitoneal disease greater than 1 cm and no greater than 1 cm residual intraperitoneal disease OR Stage IV disease The following histologies are eligible: Serous adenocarcinoma Malignant Brenner's tumor Mucinous adenocarcinoma Endometrioid adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Measurable disease not required Cytologic confirmation of malignant pleural effusion required if sole basis of entry No borderline (low malignant potential) carcinoma No unclassified ovarian cancer, i.e., thought to be of ovarian origin but unexplored or unable to verify tumor arising from ovarian stroma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST, ALT, and GGT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal LDH no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No history of congestive heart failure No history of unstable angina No myocardial infarction within 6 months Other: No severe infection, including septicemia No severe gastrointestinal bleeding No history of second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging laparotomy and primary cytoreductive surgery

Study Design

Total Participants: 324
Study Start date:
March 01, 1996
Estimated Completion Date:

Study Description

OBJECTIVES: I. Compare progression free and overall survival and frequency of response in patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin. II. Determine the incidence and severity of adverse events, including catheter complications and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and measurable disease (yes vs no). Patients are randomized into one of two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6 courses.

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.

Connect with a study center

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033-0800
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • Women's Cancer Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • Vincent T. Lombardi Cancer Research Center, Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Walter Reed Army Medical Center

    Washington, District of Columbia 20307-5000
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University Hospital - Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • MBCCOP - Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chicago Cancer Research Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-5265
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Johns Hopkins Oncology Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Cooper Hospital/University Medical Center

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Cancer Center of Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • University of Rochester Cancer Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina 27599-7295
    United States

    Site Not Available

  • Duke Comprehensive Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157-1082
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ireland Cancer Center

    Cleveland, Ohio 44106-5065
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma 73190
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425-0721
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • CCOP - Baptist Cancer Institute

    Memphis, Tennessee 38117
    United States

    Site Not Available

  • Simmons Cancer Center - Dallas

    Dallas, Texas 75235-9154
    United States

    Site Not Available

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195-6043
    United States

    Site Not Available

  • Tacoma General Hospital

    Tacoma, Washington 98405
    United States

    Site Not Available

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