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

This study has been terminated.
Sponsor:
Information provided by:
Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier:
NCT00264134
First received: December 8, 2005
Last updated: January 18, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Extensive Stage Unresectable
 Drug: Docetaxel
Drug: Irinotecan
Drug: Carboplatin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Kentuckiana Cancer Institute:

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.

Estimated Enrollment: 40
Study Start Date: June 2003
Estimated Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264134

Locations
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Kentuckiana Cancer Institute
Investigators
Principal Investigator: Shawn Glisson, MD Kentuckiana Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00264134     History of Changes
Other Study ID Numbers: 1047791, CPTAIV-0020-339
Study First Received: December 8, 2005
Last Updated: January 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Kentuckiana Cancer Institute:
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Irinotecan
 Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013