NCT00005861

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

May 19, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Last Updated

June 10, 2013

Status Verified

August 1, 2002

Enrollment Period

5.3 years

First QC Date

June 2, 2000

Last Update Submit

June 7, 2013

Conditions

Endometrial Cancer

Keywords

stage III endometrial carcinomastage IV endometrial carcinomarecurrent endometrial carcinoma

Interventions

pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • 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.

    PMID: 15975638RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Howard D. Homesley, MD

    Gynecologic Oncology Network

    STUDY CHAIR

  • Paula M. Fracasso, MD, PhD

    Washington University Siteman Cancer Center

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

June 2, 2000

First Posted

May 19, 2003

Study Start

May 1, 2000

Primary Completion

August 1, 2005

Last Updated

June 10, 2013

Record last verified: 2002-08

Locations

US(10)