Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer|
- patient response rate to weekly taxotere and gemcitabine [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Evaluate toxicity of weekly Taxotere and Gemcitabine [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2000|
|Study Completion Date:||September 2007|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
- Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
- Determine the overall and progression-free survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278460
|Study Chair:||Antonius A. Miller, MD||Comprehensive Cancer Center of Wake Forest University|