Status:

COMPLETED

Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

Lead Sponsor:

SCRI Development Innovations, LLC

Collaborating Sponsors:

Bristol-Myers Squibb

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination w...

Detailed Description

Upon determination of eligibility all patients will receive: * Docetaxel + Gemcitabine + Cetuximab

Eligibility Criteria

Inclusion

  • To be included in the study, you must meet the following criteria:
  • 18 years of age or older
  • Non-small cell lung cancer confirmed by biopsy
  • Unresectable stage III or IV disease
  • Measurable disease
  • Must not have received any prior chemotherapy for lung cancer
  • Able to perform activities of daily living without considerable assistance
  • Adequate bone marrow, kidney, and liver function
  • Signed informed consent

Exclusion

  • You cannot participate in the study if any of the following apply to you:
  • History of serious heart disease within six months prior to study entry
  • Prior treatment with agents that target the EGFR pathway
  • History of any other uncontrolled or significant disease
  • Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

69 Patients enrolled

Trial Details

Trial ID

NCT00193453

Start Date

July 1 2005

End Date

December 1 2009

Last Update

November 13 2012

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Northeast Alabama Regional Medical Center

Anniston, Alabama, United States, 36207

2

Northeast Arkansas Clinic

Jonesboro, Arkansas, United States, 72401

3

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

4

Gainsville Hematology Oncology Associates

Gainesville, Florida, United States, 32605