NCT00272558

Brief Summary

The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

5 years

First QC Date

January 3, 2006

Last Update Submit

September 17, 2009

Conditions

Malignant Pleural Mesothelioma

Keywords

Malignant Pleural MesotheliomaChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Response

Secondary Outcomes (2)

  • Survival

  • Feasibility

Interventions

Carboplatin and VinorelbineDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically verified malignant pleural Mesothelioma
  • Age above 18 years
  • Performance status 0-2

You may not qualify if:

  • No previous chemotherapy
  • Normal renal, liver and bone marrow function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Oncol., Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

CarboplatinVinorelbine

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Jens B Sorensen, MD

    Dept. Oncology, Rigshospitalet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 6, 2006

Study Start

September 1, 2004

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

DK(1)