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

Esophageal Cancer Clinical Trial

Official title:

Phase II Study to Evaluate Efficacy and Safety of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer. This Study is an Extension Study for Japanese Registration Only.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344552
• Other study ID #: CA139-540
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2006
• Last updated: November 12, 2009
• Start date: June 2006
• Est. completion date: March 2008

Study information

• Verified date: November 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Paclitaxel
Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over

Locations

Country	Name	City	State
Japan	Local Institution	Chuo-Ku	Tokyo
Japan	Local Institution	Kashiwa-Shi	Chiba
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Osaka
Japan	Local Institution	Osaka-Sayama City	Osaka
Japan	Local Institution	Sagamihara-Shi	Kanagawa
Japan	Local Institution	Saitama
Japan	Local Institution	Suita-Shi	Osaka
Japan	Local Institution	Sunto-Gun	Shizuoka
Japan	Local Institution	Takatsuki-Shi	Osaka
Japan	Local Institution	Toshima-Ku	Tokyo
Japan	Local Institution	Utsunomiya	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		at the end of the study	No
Primary	Safety		at the end of the study	Yes
Secondary	Response duration		at the end of the study	No
Secondary	Time to progression (TTP)		at the end of the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm