NCT00264134

Brief Summary

Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer. Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

First QC Date

December 8, 2005

Last Update Submit

January 18, 2010

Conditions

Non-small Cell Lung CancerExtensive Stage Unresectable

Keywords

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.

Secondary Outcomes (1)

  • Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.

Interventions

DocetaxelDRUG
IrinotecanDRUG
CarboplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60%

You may not qualify if:

  • untreated CNS metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DocetaxelIrinotecanCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic CompoundsCoordination Complexes

Study Officials

  • Shawn Glisson, MD

    Kentuckiana Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2005

First Posted

December 12, 2005

Study Start

June 1, 2003

Study Completion

October 1, 2005

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

US(1)