Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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 oxaliplatin works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease|
- Response rate as measured by RECIST criteria [ Time Frame: At study completion ] [ Designated as safety issue: No ]
- Toxicity as monitored by DSMC [ Time Frame: At study completion ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Study Completion Date:||May 2010|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- Determine the efficacy and safety of gemcitabine hydrochloride and oxaliplatin as second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer.
- Determine overall response in patients treated with this regimen.
- Determine time to progression, time to treatment failure, and overall survival of these patients.
- Determine the type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days after completion of study treatment.
- Assess the quality of life of these patients.
- Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the beginning of each course, at the completion of study treatment, and then every 6 weeks thereafter.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Caio Max S. Rocha Lima, MD||University of Miami Sylvester Comprehensive Cancer Center|