Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease
- 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
- 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
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate as measured by RECIST criteria
At study completion
Caio Max S. Rocha Lima, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|