As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with resistant relapse, respectively. Because of single-agent activity, different mechanism of action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and gemcitabine combinations are attractive for testing in clinical trials.
The treatment consists of paclitaxel 80 mg/m2 and gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle. Patients receive treatment every 3 weeks till disease progression
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
To evaluate the response rate of paclitaxel plus gemcitabine
Time frame: the ratio between the number of responders and number of patients assessable for tumor response
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
Time frame: the first day of treatment to the date that disease progression is reported
To examine the association between genotypes of paclitaxel biotransformation and the pharmacokinetics /
Time frame: before the first treatment date, each response evaluation until disease progression
To estimate the overall survival
Time frame: the first day of treatment to death date
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