NCT00102609

Brief Summary

The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2005

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

January 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

First QC Date

January 31, 2005

Last Update Submit

January 9, 2013

Conditions

Soft Tissue SarcomaSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Keywords

DoxorubicinAdriamycinTrabectedinYondelisEcteinascidin 743Filgrastim, AntineoplasticAntineoplastic AgentsPharmacologic ActionsAlkylating Agents

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events as a measure of safety

    Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up)

Secondary Outcomes (5)

  • The number of patients with clinically relevant changes in clinically laboratory tests

    Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)

  • Number of patients with neutropenia

    Up to approximately19 weeks (six 3-week treatment cycles+30 day safety follow up)

  • Plasma concentrations of trabectedin (Yondelis)

    During the first 3 weeks of treatment

  • Plasma concentrations of Doxorubicin

    During the first 3 weeks of treatment

  • Plasma concentrations of Doxorubicinol

    During the first 3 weeks of treatment

Study Arms (1)

Trabectedin and doxorubicin

EXPERIMENTAL

Doxorubicin (50 to 75 mg/m2) administered intravenously on Day 1 followed by trabectedin (0.9 to 1.3 mg/m2) administered intravenously on Day 1 every 3 weeks for up to 6 cycles. Dexamethasone 20 mg administered intravenously will be given within 1 hour before the start of doxorubicin. Patients may receive filgrastim for unmanageable neutropenia.

Drug: DoxorubicinDrug: TrabectedinDrug: Dexamethasone

Interventions

DoxorubicinDRUG

Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1

Trabectedin and doxorubicin
TrabectedinDRUG

Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles

Trabectedin and doxorubicin
DexamethasoneDRUG

Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin

Trabectedin and doxorubicin

Eligibility Criteria

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

You may qualify if:

  • Have a diagnosis of soft tissue sarcoma, recurrent or persistent
  • Signed informed consent obtained for all patients before performing any study-related procedures

You may not qualify if:

  • Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy)
  • Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin
  • Less than 4 weeks since radiation therapy
  • Known metastases (spread) of cancer to the central nervous system
  • Other ongoing serious illness present at the time of enrollment as determined by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Interventions

DoxorubicinTrabectedinDexamethasone

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesDioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, Fluorinated

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial

    Johnson & Johnson Pharmaceutical Research and Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2005

First Posted

February 1, 2005

Study Start

April 1, 2005

Study Completion

October 1, 2007

Last Updated

January 10, 2013

Record last verified: 2013-01