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Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00971867
First received: September 3, 2009
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects


Condition Intervention Phase
Head and Neck 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 Head and Neck Cancer

Resource links provided by NLM:

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse event [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: Every 7 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Every 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel Drug: Paclitaxel
Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Other Names:
  • Taxol
  • BMS-181339

  Eligibility

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

Inclusion Criteria:

  • Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with aclitaxel as the discretion of the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971867

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00971867     History of Changes
Other Study ID Numbers: CA139-539
Study First Received: September 3, 2009
Last Updated: September 10, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
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 June 18, 2013