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

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00344552
Enrollment
53
Registered
2006-06-27
Start date
2006-06-30
Completion date
2008-03-31
Last updated
2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

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.

Interventions

DRUGPaclitaxel

Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall response rateat the end of the study
Safetyat the end of the study

Secondary

MeasureTime frame
Response durationat the end of the study
Time to progression (TTP)at the end of the study

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026