Phase II Study of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer

Phase 2

Completed

• Conditions: Esophageal Cancer
• Interventions: Drug: Paclitaxel

• Registration Number: NCT00344552
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this clinical research study is to learn if BMS-181339 can shrink or slow the growth of the cancer in patients with advanced or recurrent esophageal cancer. The safety of this treatment will also be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-23
• Study First Submitted QC: 2006-06-23
• Study First Posted: 2006-06-27
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-12
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Patients must have measurable disease
• Patients must have experienced on pervious chemotherapy regime
• Men and Women, with the age 20 years or older
• ECOG PS: 0-1

Exclusion Criteria

• Patients with previous therapy with Taxanes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Overall response rate	at the end of the study
Safety	at the end of the study

Secondary Outcome Measures

Name	Time	Method
Time to progression (TTP)	at the end of the study
Response duration	at the end of the study

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Saitama, Japan