Liposomal Doxorubicin in Treating Patients With Advanced 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: NCT00005861
Recruitment Status : Completed
First Posted : May 19, 2003
Last Update Posted : June 10, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

June 2, 2000
May 19, 2003
June 10, 2013
May 2000
August 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005861 on Archive Site
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Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.


  • Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer.
  • Determine the response rate, response duration, and overall survival of these patients treated with this regimen.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.

Phase 2
Primary Purpose: Treatment
Endometrial Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
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Homesley HD, Blessing JA, Sorosky J, Reid G, Look KY. Phase II trial of liposomal doxorubicin at 40 mg/m(2) every 4 weeks in endometrial carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2005 Aug;98(2):294-8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2005   (Final data collection date for primary outcome measure)


  • Histologically confirmed stage III, IV, or recurrent endometrial carcinoma for which curative radiotherapy or surgery is not an option
  • Bidimensionally measurable disease

    • Irradiated field as only site allowed if evidence of progression since radiotherapy



  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


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


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN


  • Creatinine no greater than 1.5 times ULN


  • LVEF normal by cardiac echocardiogram or MUGA


  • No concurrent active infection
  • No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer


Biologic therapy:

  • Not specified


  • Prior chemotherapy as radiosensitizer allowed
  • No prior chemotherapy for advanced or metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • Recovered from prior radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery


  • No prior therapy that would preclude study
  • No other concurrent antineoplastic agents
  • No other concurrent investigational agents
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Howard D. Homesley, MD Gynecologic Oncology Network
Investigator: Paula M. Fracasso, MD, PhD Washington University Siteman Cancer Center
Gynecologic Oncology Group
August 2002

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