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Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00005861
First received: June 2, 2000
Last updated: June 7, 2013
Last verified: August 2002
June 2, 2000
June 7, 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 ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Primary Purpose: Treatment
Endometrial Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2005   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • LVEF normal by cardiac echocardiogram or MUGA

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • No prior therapy that would preclude study
  • No other concurrent antineoplastic agents
  • No other concurrent investigational agents
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00005861
CDR0000067891
GOG-0086M
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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