NCT00344552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

Enrollment Period

1.8 years

First QC Date

June 23, 2006

Last Update Submit

November 12, 2009

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Overall response rate

    at the end of the study

  • Safety

    at the end of the study

Secondary Outcomes (2)

  • Response duration

    at the end of the study

  • Time to progression (TTP)

    at the end of the study

Study Arms (1)

1

EXPERIMENTAL
Drug: Paclitaxel

Interventions

PaclitaxelDRUG

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

Also known as: Taxol
1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with previous therapy with Taxanes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Local Institution

Nagoya, Aichi-ken, 464-8681, Japan

Location

Local Institution

Kashiwa-Shi, Chiba, 277-0882, Japan

Location

Local Institution

Sagamihara-Shi, Kanagawa, 228-8520, Japan

Location

Local Institution

Osaka, Osaka, Japan

Location

Local Institution

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Local Institution

Suita-Shi, Osaka, Japan

Location

Local Institution

Takatsuki-Shi, Osaka, 569-8686, Japan

Location

Local Institution

Saitama, Saitama, Japan

Location

Local Institution

Sunto-Gun, Shizuoka, 411-8777, Japan

Location

Local Institution

Utsunomiya, Tochigi, 320-0834, Japan

Location

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Local Institution

Toshima-Ku, Tokyo, 170-8455, Japan

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

JP(12)