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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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