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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00344552
First received: June 23, 2006
Last updated: November 12, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Esophageal Cancer
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response duration [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: June 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Paclitaxel
Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over
Other Name: Taxol

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344552

Locations
Japan
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00344552     History of Changes
Other Study ID Numbers: CA139-540
Study First Received: June 23, 2006
Last Updated: November 12, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on July 22, 2014