NCT00453323

Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks
DRUG	Capecitabine	capecitabine 900mg/m2 bid po on day 1\~14, 1 weeks rest, until disease progression

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2007-03-28
• Last updated: 2010-07-12

Locations

1 site across 1 country: South Korea