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

September 3, 2009
September 10, 2010
August 2006
November 2008   (final data collection date for primary outcome measure)
Adverse event [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00971867 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
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
Experimental: Paclitaxel
Intervention: Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00971867
CA139-539
Yes
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP