Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity. Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index.
The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. We are conducting a phase II study to evaluate the response rate and toxicity of the gemcitabine-oxaliplatin combination both given every 4 weeks in patients with advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression
gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression
National Cancer Center, Korea
Goyang-si, Gyeonggi-dog, South Korea
Response rate
Time frame: every 12 weeks during until disease progression
To access the toxicity
Time frame: the first day of the treatment to 30 days after the last dose of study drug
To estimate the time to progression and overall survival
Time frame: the first day of treatment to the date that disease progression is reported
To evaluate the improvement quality of life
Time frame: before the first treatment and every cycle d1 until diseas progression
To estimate the overall survival
Time frame: the first day of the treatment to death date
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