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Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer, Extensive Stage Unresectable

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Irinotecan
Carboplatin
Sponsored by
Kentuckiana Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60% Exclusion Criteria: untreated CNS metastases

Sites / Locations

  • Kentuckiana Cancer Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2005
Last Updated
January 18, 2010
Sponsor
Kentuckiana Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00264134
Brief Title
Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer
Official Title
A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kentuckiana Cancer Institute

4. Oversight

5. Study Description

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.
Detailed Description
A phase I/II dose escalating study to determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Extensive Stage Unresectable
Keywords
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Primary Outcome Measure Information:
Title
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
Secondary Outcome Measure Information:
Title
Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60% Exclusion Criteria: untreated CNS metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn Glisson, MD
Organizational Affiliation
Kentuckiana Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer

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