Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00004139
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Compare the complete and overall response rate to gemcitabine and docetaxel versus gemcitabine and irinotecan in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer. II. Compare the overall and failure free survival, duration of response, and toxicity associated with these combination regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs recurrent/progressive disease post surgery and/or radiotherapy). Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes immediately followed by irinotecan IV over 90 minutes on days 1 and 8. Arm II: Patients receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete response or stable disease receive treatment for least 6 courses and for 2 additional courses beyond the maximum response, and then at the investigator's discretion. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression or death.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine + Docetaxel docetaxel - Gemcitabine + Docetaxel gemcitabine hydrochloride - Gemcitabine + Irinotecan gemcitabine hydrochloride - Gemcitabine + Irinotecan irinotecan hydrochloride -
- Primary Outcome Measures
Name Time Method overall survival Up to 2 years failure-free survival Up to 2 years response rate Up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States