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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
N/A
Not Enrolling
Female
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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Gini F. Fleming, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000066794

NCT ID:

NCT00003691

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
Women's Cancer CenterPalo Alto, California  94304
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Tufts University School of MedicineBoston, Massachusetts  02111
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Scott and White HospitalTemple, Texas  76508
North Shore University HospitalManhasset, New York  11030
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
CCOP - Sooner StateTulsa, Oklahoma  74136
Medicine BranchBethesda, Maryland  20892
Radiation Oncology BranchBethesda, Maryland  20892
Memorial HospitalWorcester, Massachusetts  01605