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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00971841
First received: September 3, 2009
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.


Condition Intervention Phase
Esophageal Cancer
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of Adverse Events (AEs) Per Participant [ Time Frame: Weekly Day 1 to 4 years ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.


Secondary Outcome Measures:
  • Number of Participants With Complete Response to Tumor [ Time Frame: Every 7 weeks Day 1 to 4 years ] [ Designated as safety issue: No ]
    Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).


Enrollment: 1
Study Start Date: March 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel
One hour intravenous infusion on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consists of 49 days. Day 1 dose same level as last dose of original Study CA139-540 (100mg/m2, 80 mg/m2, or 60 mg/m2). Treatment to continue until disease progression or unacceptable toxicity apparent.
Drug: Paclitaxel
Other Names:
  • Taxol
  • BMS-181339

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Subjects with advanced or recurrent esophageal cancer who have completed the previous late Phase 2 study (CA139-540) and for who continued therapy with paclitaxel would be beneficial as deemed by the investigator(s).

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00971841

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00971841     History of Changes
Other Study ID Numbers: CA139-557
Study First Received: September 3, 2009
Results First Received: May 24, 2013
Last Updated: July 18, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 20, 2014