A Phase 2 interventional study of Paclitaxel and Capecitabine in Esophageal Cancer, sponsored by National Cancer Center, Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-12.
Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 33 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Paclitaxel · Drug: Capecitabine
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
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
This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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National Cancer Center, Korea