Capecitabine is an orally administered fluoropyrimidine that is converted by 5-FU by thymidine phosphorylase (TP), preferentially in tumor tissues and has demonstrated activity as single agent in patients with gastrointestinal cancer. Up-regulation of TP after taxane treatment in vitro suggested that there may be synergistic effects in combined treatment with taxane and capecitabine. The combination of taxane and capecitabine was reported to be highly active against non-small cell lung cancer, breast cancer, and stomach cancer.
Paclitaxel-80 mg/m2/IV D1 \& D8 q 3 weeks Capecitabine-900 mg/m2/PO twice daily Days 1-14 q 3 weeks Patients receive treatment every 3 weeks till disease progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks
capecitabine 900mg/m2 bid po on day 1\~14, 1 weeks rest, until disease progression
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
To evaluate the response rate
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 and overall survival
Time frame: the first day of treatment to the date that disease progression is reported
To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy.
Time frame: before the first treatment
To estimate the overall survival
Time frame: the first day of the treatment to death date
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