Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00005861

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: pegylated liposomal doxorubicin hydrochloride	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
2	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
3	Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242-1009
4	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
5	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
6	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
7	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
8	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
9	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
10	Brookview Research, Inc.	Nashville	Tennessee	United States	37203