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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

Phase 3
18 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- Histologically confirmed primary stage III, stage IV, or recurrent endometrial

- 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



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Platelet count at least 100,000/mm^3

- Granulocyte count at least 1,500/mm^3


- SGPT no greater than 3 times upper limit of normal

- Bilirubin normal


- Creatinine no greater than 1.6 mg/dL


- LVEF at least 50% within past 6 months

- No uncontrolled angina

- No third-degree or complete heart block unless a pacemaker is in place


- No serious peripheral neuropathy


- No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer

- No uncontrolled infection

- No sensitivity to E. coli-derived drug preparations


Biologic therapy

- Prior biologic therapy allowed

- No concurrent biologic therapy


- No prior cytotoxic chemotherapy, including chemotherapy used for radiation

- No prior chemotherapy for any prior malignancy

Endocrine therapy

- Prior hormone therapy allowed

- No concurrent hormone therapy


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


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Gini F. Fleming, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Tufts University School of Medicine Boston, Massachusetts  02111
Brookview Research, Inc. Nashville, Tennessee  37203
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Greenville Greenville, South Carolina  29615
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Evanston Evanston, Illinois  60201
CCOP - Scott and White Hospital Temple, Texas  76508
North Shore University Hospital Manhasset, New York  11030
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
CCOP - Sooner State Tulsa, Oklahoma  74136
Medicine Branch Bethesda, Maryland  20892
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Memorial Hospital Worcester, Massachusetts  01605