NCT00050440

Brief Summary

The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Geographic Reach
4 countries

14 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

July 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

First QC Date

December 9, 2002

Last Update Submit

January 7, 2013

Conditions

Endometrial NeoplasmsUterine NeoplasmsGenital Neoplasms, Female Urogenital Neoplasms

Keywords

EndometrialCancerCarcinomaTrabectedinEcteinascidin 743ET743Antineoplastic AgentsAlkylating AgentsMolecular Mechanisms of Pharmacological Action

Outcome Measures

Primary Outcomes (1)

  • Number of patients with objective response

    Up to approximately 3 years

Secondary Outcomes (4)

  • Overall survival (OS)

    Up to approximately 3 years

  • The number of patients with adverse events

    Up to approximately 3 years

  • Time to progression (TTP)

    Up to approximately 3 years

  • Progression free survival (PFS),

    Up to approximately 3 years

Study Arms (1)

Trabectedin

EXPERIMENTAL

Trabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose.

Drug: TrabectedinDrug: Dexamethasone

Interventions

TrabectedinDRUG

Trabectedin 1.3 mg/m2 administered intravenously every 21 days.

Trabectedin
DexamethasoneDRUG

Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose

Trabectedin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of advanced or metastatic endometrial carcinoma
  • Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
  • At least one measureable tumor lesion
  • Adequate bone marrow, hepatic and renal function
  • Performance status ECOG 0 or 1

You may not qualify if:

  • Prior exposure to trabectedin
  • Known hypersensitivity to dexamethasone or to any of the components of trabectedin
  • Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
  • History of another neoplastic disease unless in remission for more than 5 years
  • Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
  • Current pregnancy, lactation, or childbearing potential without adequate method of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Maastricht, Netherlands

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Obninsk, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Saint, Russia

Location

Related Links

MeSH Terms

Conditions

Endometrial NeoplasmsUterine NeoplasmsNeoplasmsCarcinoma

Interventions

TrabectedinDexamethasone

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2002

First Posted

December 10, 2002

Study Start

July 1, 2002

Study Completion

July 1, 2004

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

CA(1)NL(1)US(8)RU(4)