NCT00375999

Docetaxel and Epirubicin in Advanced Gastric Cancer

A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints: 1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure. 2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel and epirubicin

Timeline

• Start date: 2006-09-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2006-09-14
• Last updated: 2014-03-03
• Results posted: 2014-03-03

Locations

1 site across 1 country: South Korea