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

Brief Summary:

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 or disease Intervention/treatment Phase
Endometrial Cancer Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Study Start Date : December 1998
Actual Primary Completion Date : June 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003691

  Show 73 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Gini F. Fleming, MD University of Chicago

Publications of Results:
Other Publications:
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. Identifier: NCT00003691     History of Changes
Obsolete Identifiers: NCT00698620
Other Study ID Numbers: CDR0000066794
First Posted: June 24, 2004    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: September 2010

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
Uterine Diseases
Genital Diseases, Female
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors