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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00344552
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : November 13, 2009
Information provided by:
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Paclitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Paclitaxel
Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over
Other Name: Taxol

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: at the end of the study ]
  2. Safety [ Time Frame: at the end of the study ]

Secondary Outcome Measures :
  1. Response duration [ Time Frame: at the end of the study ]
  2. Time to progression (TTP) [ Time Frame: at the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00344552

Local Institution
Nagoya, Aichi, Japan, 464-8681
Local Institution
Kashiwa-Shi, Chiba, Japan, 277-0882
Local Institution
Sagamihara-Shi, Kanagawa, Japan, 228-8520
Local Institution
Osaka-Sayama City, Osaka, Japan, 589-8511
Local Institution
Suita-Shi, Osaka, Japan
Local Institution
Takatsuki-Shi, Osaka, Japan, 569-8686
Local Institution
Sunto-Gun, Shizuoka, Japan, 411-8777
Local Institution
Utsunomiya, Tochigi, Japan, 320-0834
Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045
Local Institution
Toshima-Ku, Tokyo, Japan, 170-8455
Local Institution
Osaka, Japan
Local Institution
Saitama, Japan
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00344552     History of Changes
Other Study ID Numbers: CA139-540
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action