NCT00004915

Brief Summary

RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using raloxifene may fight endometrial cancer by reducing the production of estrogen. PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who have persistent or recurrent endometrial cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1998

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 30, 2004

Completed
Last Updated

June 6, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

March 7, 2000

Last Update Submit

May 31, 2012

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma

Interventions

raloxifeneDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Recurrent endometrial cancer Evidence of persistent or recurrent disease 4 weeks following primary treatment with radiation and surgery Bidimensionally measurable disease Not a candidate for curative salvage radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No history of unexplained or uncontrolled thromboembolic disease No active thromboembolic disease Other: No active or uncontrolled second malignancy HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy for early stage or advanced endometrial cancer Endocrine therapy: At least 4 weeks since prior hormonal therapy for early stage or advanced endometrial cancer Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Phillip Y. Roland, MD

    Florida Gynecologic Oncology - Fort Myers

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

August 30, 2004

Study Start

November 1, 1998

Primary Completion

February 1, 2000

Study Completion

February 1, 2000

Last Updated

June 6, 2012

Record last verified: 2012-05

Locations

US(1)