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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate
Safety

Secondary Outcome Measures

Response duration
Time to progression (TTP)

Full Information

First Posted
June 23, 2006
Last Updated
November 12, 2009
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00344552
Brief Title
Phase II Study of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
at the end of the study
Title
Safety
Time Frame
at the end of the study
Secondary Outcome Measure Information:
Title
Response duration
Time Frame
at the end of the study
Title
Time to progression (TTP)
Time Frame
at the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Local Institution
City
Kashiwa-Shi
State/Province
Chiba
ZIP/Postal Code
277-0882
Country
Japan
Facility Name
Local Institution
City
Sagamihara-Shi
State/Province
Kanagawa
ZIP/Postal Code
228-8520
Country
Japan
Facility Name
Local Institution
City
Osaka-Sayama City
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Local Institution
City
Suita-Shi
State/Province
Osaka
Country
Japan
Facility Name
Local Institution
City
Takatsuki-Shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Local Institution
City
Sunto-Gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Local Institution
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Local Institution
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution
City
Toshima-Ku
State/Province
Tokyo
ZIP/Postal Code
170-8455
Country
Japan
Facility Name
Local Institution
City
Osaka
Country
Japan
Facility Name
Local Institution
City
Saitama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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