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Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin hydrochloride
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chao Family Comprehensive Cancer Center
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center
  • New England Medical Center Hospital
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Arthur G. James Cancer Hospital - Ohio State University
  • Brookview Research, Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 7, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005861
Brief Title
Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
Official Title
Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard D. Homesley, MD
Organizational Affiliation
Gynecologic Oncology Network
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paula M. Fracasso, MD, PhD
Organizational Affiliation
Washington University Siteman Cancer Center
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15975638
Citation
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. doi: 10.1016/j.ygyno.2005.05.016.
Results Reference
result

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Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

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