NCT00006377

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin, paclitaxel, and carboplatin in treating patients who have primary stage III, stage IV, 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 Jun 2000

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

June 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 30, 2003

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

2.6 years

First QC Date

October 4, 2000

Last Update Submit

June 17, 2013

Conditions

Endometrial Cancer

Keywords

stage III endometrial carcinomastage IV endometrial carcinomarecurrent endometrial carcinoma

Interventions

carboplatinDRUG
doxorubicin hydrochlorideDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven primary stage III or IV or recurrent endometrial cancer * Bidimensionally measurable disease by x-ray, CT scan, MRI scan, or physical exam * Sole site may be within a previously irradiated area if documented disease progression since prior radiotherapy PATIENT CHARACTERISTICS: Age: * Adult Performance status: * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin, SGOT, and alkaline phosphatase no greater than 1.5 times normal Renal: * Creatinine no greater than 1.8 mg/dL Cardiovascular: * Left ventricular ejection fraction at least 50% Other: * No active uncontrolled infection * No greater than grade II neuropathy * No other active malignancy * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior doxorubicin * Greater than 6 months since prior paclitaxel, carboplatin, or other platinum compounds Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

CarboplatinDoxorubicinPaclitaxel

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)

Coordination ComplexesOrganic ChemicalsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Paul Sabbatini, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2000

First Posted

May 30, 2003

Study Start

June 1, 2000

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(1)