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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003691
Recruitment Status : Completed
First Posted : June 24, 2004
Last Update Posted : July 9, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

November 1, 1999
June 24, 2004
July 9, 2013
December 1998
June 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003691 on Archive Site
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Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
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

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.


  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Endometrial Cancer
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: doxorubicin hydrochloride
  • Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2004   (Final data collection date for primary outcome measure)


  • 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



  • 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 sensitization
  • 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 spine


  • Not specified
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Gini F. Fleming, MD University of Chicago
Gynecologic Oncology Group
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP