Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer
1 other identifier
interventional
69
1 country
10
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 with a novel agent cetuximab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lung-cancer
Started Jul 2005
Typical duration for phase_2 lung-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
November 13, 2012
CompletedNovember 13, 2012
October 1, 2012
3.6 years
September 12, 2005
October 11, 2012
October 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Clinical Response Rate
Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.
18 months
Secondary Outcomes (2)
Progression Free Survival (PFS)
18 months
Response Duration
18 months
Study Arms (1)
Intervention
EXPERIMENTALNewly-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).
Interventions
100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 \& 15, all subsequent cycles 250mg/m2 IV day 1, 8, \& 15
Eligibility Criteria
You may qualify if:
- To be included in the study, you must meet the following criteria:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Bristol-Myers Squibbcollaborator
Study Sites (10)
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Gainsville Hematology Oncology Associates
Gainesville, Florida, 32605, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Mercy Hospital
Portland, Maine, 04101, United States
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, 19026, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related Publications (1)
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.
PMID: 20439197RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
David R. Spigel, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
July 1, 2005
Primary Completion
February 1, 2009
Study Completion
December 1, 2009
Last Updated
November 13, 2012
Results First Posted
November 13, 2012
Record last verified: 2012-10