Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003691
First received: November 1, 1999
Last updated: July 8, 2013
Last verified: September 2010
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Biological: filgrastim
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 240
Study Start Date: December 1998
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.
  • Compare the toxicities of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.
  • Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.

Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary stage III, stage IV, or recurrent endometrial carcinoma

    • Very poor potential for cure by radiotherapy or surgery alone or in combination
  • Measurable disease

    • Disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Granulocyte count at least 1,500/mm^3

Hepatic

  • SGPT no greater than 3 times upper limit of normal
  • Bilirubin normal

Renal

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular

  • LVEF at least 50% within past 6 months
  • No uncontrolled angina
  • No third-degree or complete heart block unless a pacemaker is in place

Neurologic

  • No serious peripheral neuropathy

Other

  • No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer
  • No uncontrolled infection
  • No sensitivity to E. coli-derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed
  • No concurrent biologic therapy

Chemotherapy

  • No prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization
  • No prior chemotherapy for any prior malignancy

Endocrine therapy

  • Prior hormone therapy allowed
  • No concurrent hormone therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine

Surgery

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003691

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Women's Cancer Center
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
Medicine Branch
Bethesda, Maryland, United States, 20892
Radiation Oncology Branch
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Memorial Hospital
Worcester, Massachusetts, United States, 01605
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-9832
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
CCOP - Sooner State
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States, 38117
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Canada, Ontario
NCIC-Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Gini F. Fleming, MD University of Chicago
  More Information

Additional Information:
Publications:
Fleming GF, Brunetto VL, Mundt AJ, et al.: Randomized trial of doxorubicin (DOX) plus cisplatin (CIS) versus DOX plus CIS plus paclitaxel (TAX) in patients with advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group (GOG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-807, 2002.
Modesitt S, Tian C, Kryscio R, et al.: Impact of body mass index (BMI) on treatment outcomes in advanced or recurrent endometrial cancer patients receiving doxorubicin/cisplatin chemotherapy: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-93, 2006.

ClinicalTrials.gov Identifier: NCT00003691     History of Changes
Obsolete Identifiers: NCT00698620
Other Study ID Numbers: CDR0000066794, GOG-0177
Study First Received: November 1, 1999
Last Updated: July 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage III endometrial carcinoma
stage IV endometrial carcinoma
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Liposomal doxorubicin
Cisplatin
Doxorubicin
Paclitaxel
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014