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

Phase 1

Terminated

• Conditions: Non-small Cell Lung Cancer; Extensive Stage Unresectable

• Registration Number: NCT00264134
• Lead Sponsor: Kentuckiana Cancer Institute

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.

Study Timeline

• Study Start: 2003-06
• Study Completion: 2005-10
• Study First Submitted: 2005-12-08
• Study First Submitted QC: 2005-12-08
• Study First Posted: 2005-12-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-18
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Kentuckiana Cancer Institute; 🇺🇸 Louisville, Kentucky, United States