Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
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.
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Trial of Gemcitabine/Docetaxel and Gemcitabine/Irinotecan in Stage IIIB/IV Non-Small Cell Lung Cancer|
|Study Start Date:||September 1999|
|Study Completion Date:||January 2006|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
|Experimental: Gemcitabine + Irinotecan||Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride|
|Experimental: Gemcitabine + Docetaxel||Drug: docetaxel Drug: gemcitabine hydrochloride|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004139
|United States, District of Columbia|
|Vincent T. Lombardi Cancer Research Center, Georgetown University|
|Washington, District of Columbia, United States, 20007|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5000|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Nevada|
|CCOP - Southern Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425-0721|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|United States, Tennessee|
|University of Tennessee, Memphis Cancer Center|
|Memphis, Tennessee, United States, 38163|
|Study Chair:||Caio Max S. Rocha Lima, MD||Medical University of South Carolina|