Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00193453
Last Updated: 2012-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2005-07-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Docetaxel + Gemcitabine + Cetuximab
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
Gemcitabine
1000mg/m2 30min IV, Day 1 \& 8
Docetaxel
30mg/m2, 30min IV, day 1 \& 8
Cetuximab
100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 \& 15, all subsequent cycles 250mg/m2 IV day 1, 8, \& 15
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine
1000mg/m2 30min IV, Day 1 \& 8
Docetaxel
30mg/m2, 30min IV, day 1 \& 8
Cetuximab
100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 \& 15, all subsequent cycles 250mg/m2 IV day 1, 8, \& 15
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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 Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David R. Spigel, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Mercy Hospital
Portland, Maine, United States
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Spigel DR, Greco FA, Thompson DS, Webb C, Rubinsak J, Inhorn RC, Reeves J Jr, Vazquez ER, Lane CM, Burris HA 3rd, Hainsworth JD. Phase II study of cetuximab, docetaxel, and gemcitabine in patients with previously untreated advanced non-small-cell lung cancer. Clin Lung Cancer. 2010 May;11(3):198-203. doi: 10.3816/CLC.2010.n.026.
Related Links
Access external resources that provide additional context or updates about the study.
Published article in Clinical Lung Cancer
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCRI LUN 92
Identifier Type: -
Identifier Source: org_study_id