Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT00193453
- Lead Sponsor
- SCRI Development Innovations, LLC
- 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.
- Detailed Description
Upon determination of eligibility all patients will receive:
* Docetaxel + Gemcitabine + Cetuximab
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Gemcitabine 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). Intervention Cetuximab 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). Intervention Docetaxel 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).
- Primary Outcome Measures
Name Time Method Overall Clinical Response Rate 18 months 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.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) 18 months Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.
Response Duration 18 months The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Trial Locations
- Locations (10)
Gainsville Hematology Oncology Associates
🇺🇸Gainesville, Florida, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Northeast Arkansas Clinic
🇺🇸Jonesboro, Arkansas, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Mercy Hospital
🇺🇸Portland, Maine, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Consultants in Blood Disorders and Cancer
🇺🇸Louisville, Kentucky, United States
Consultants in Medical Oncology and Hematology
🇺🇸Drexel Hill, Pennsylvania, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States