S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission

Last updated: October 7, 2014
Sponsor: Southwest Oncology Group
Overall Status: Completed

Phase

3

Condition

Ovarian Cancer

Pelvic Cancer

Malignant Ascites

Treatment

N/A

Clinical Study ID

NCT00003120
CDR0000065875
U10CA032102
GOG-178
SWOG-S9701
  • Ages > 18
  • Female

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter period of time is as effective as a standard course of treatment for advanced ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial laparotomy Must have attained a clinically defined complete remission (CR) following treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination chemotherapy regimen by achieving the following: No evidence of cancer on physical examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy Must have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to study Must register for study within 21 to 56 days after prior chemotherapy Not concurrently registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line treatment phase III GOG trials

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other: No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin allowed if initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No second look laparotomy or laparoscopy

Study Design

Total Participants: 308
Study Start date:
November 01, 1997
Estimated Completion Date:
November 30, 2012

Study Description

OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on progression free survival and overall survival in women with advanced ovarian, fallopian tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated with prolonged paclitaxel administration in these patients.

OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression or 1 year from registration, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 5 years.

Connect with a study center

  • MBCCOP - Gulf Coast

    Mobile, Alabama 36688
    United States

    Site Not Available

  • CCOP - Greater Phoenix

    Phoenix, Arizona 85006-2726
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Phoenix (Hayden)

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona 85723
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California 91010-3000
    United States

    Site Not Available

  • Scripps Clinic Cancer Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California 90822
    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 and Hospital

    Los Angeles, California 90033-0804
    United States

    Site Not Available

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California 90073
    United States

    Site Not Available

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California 94553
    United States

    Site Not Available

  • CCOP - Bay Area Tumor Institute

    Oakland, California 94609-3305
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California 95403
    United States

    Site Not Available

  • David Grant Medical Center

    Travis Air Force Base, California 94535
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80010
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado 80220
    United States

    Site Not Available

  • CCOP - Atlanta Regional

    Atlanta, Georgia 30342-1701
    United States

    Site Not Available

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia 30905-5650
    United States

    Site Not Available

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois 60612-7323
    United States

    Site Not Available

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois 60611-3013
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois 60141
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-7357
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas 67218
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky 40511-1093
    United States

    Site Not Available

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana 71130-3932
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts 02130
    United States

    Site Not Available

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109-0752
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201-1379
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan 48201-1932
    United States

    Site Not Available

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Providence Hospital - Southfield

    Southfield, Michigan 48075-9975
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi 39531-2410
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Keesler Medical Center - Keesler AFB

    Keesler AFB, Mississippi 39534-2576
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • CCOP - St. Louis-Cape Girardeau

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St. Louis University Health Sciences Center

    Saint Louis, Missouri 63110-0250
    United States

    Site Not Available

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri 65807
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico 87108-5138
    United States

    Site Not Available

  • Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina 27104-4241
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio 45220-2288
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43206
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio 45428
    United States

    Site Not Available

  • CCOP - Dayton

    Kettering, Ohio 45429
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio 43623-3456
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • CCOP - Columbia River Program

    Portland, Oregon 97213
    United States

    Site Not Available

  • Oregon Cancer Center

    Portland, Oregon 97201-3098
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon 97207
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas 75216
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-0209
    United States

    Site Not Available

  • Texas Tech University Health Science Center

    Lubbock, Texas 79423
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78284-7811
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas 78284
    United States

    Site Not Available

  • CCOP - Scott and White Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Temple

    Temple, Texas 76504
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah 84148
    United States

    Site Not Available

  • CCOP - Virginia Mason Research Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington 98108
    United States

    Site Not Available

  • CCOP - Northwest

    Tacoma, Washington 98405-0986
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431-5000
    United States

    Site Not Available

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