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OpenTrials
Completed

NCT Number: NCT00344552

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

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

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

Other names: Taxol

Primary outcomes

  1. Overall response rate

    Time frame: at the end of the study

  2. Safety

    Time frame: at the end of the study

Secondary outcomes

  1. Response duration

    Time frame: at the end of the study

  2. Time to progression (TTP)

    Time frame: at the end of the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 27, 2006
Registry last updated
Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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