NCT00050414

Brief Summary

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2002

Typical duration for phase_2

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

October 1, 2002

Completed
2 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
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

First QC Date

December 9, 2002

Last Update Submit

January 9, 2013

Conditions

Ovarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, Female

Keywords

Ovarian cancerOvaryCancerTrabectedinYondelisET743Ecteinascidin 743Antineoplastic Agents, AlkylatingAlkylating Agents

Outcome Measures

Primary Outcomes (1)

  • Number of patients with objective response

    Up to approximately 3 years

Secondary Outcomes (8)

  • The number of patients with an unbiased objective response

    Up to approximately 3 years

  • Progression-free survival

    Up to approximately 3 years

  • Time to progression

    Up to approximately 3 years

  • Overall survival

    Up to approximately 3 years

  • Duration of response

    Up to approximately 3 years

  • +3 more secondary outcomes

Study Arms (1)

Trabectedin

EXPERIMENTAL

Trabectedin 0.58 mg/m2 administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.

Drug: TrabectedinDrug: Dexamethasone

Interventions

TrabectedinDRUG

Trabectedin 0.58 mg/m2, administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression.

Trabectedin
DexamethasoneDRUG

Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.

Trabectedin

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of advanced epithelial ovarian cancer
  • Progression or recurrence during or after platinum-containing regimen
  • At least one measureable tumor lesion
  • Adequate bone marrow, hepatic and renal function
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

You may not qualify if:

  • Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone
  • Pregnant or lactating women
  • Known metastases (spread) of cancer to the central nervous system
  • History of another neoplastic disease unless in remission for five years or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, Female

Interventions

TrabectedinDexamethasone

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

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

October 1, 2002

Study Completion

September 1, 2005

Last Updated

January 10, 2013

Record last verified: 2013-01