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

January 18, 2010 updated by: Kentuckiana Cancer Institute

A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kentuckiana Cancer Institute

Investigators

  • Principal Investigator: Shawn Glisson, MD, Kentuckiana Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 18, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1047791
  • CPTAIV-0020-339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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