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Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck 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.
 
ClinicalTrials.gov Identifier: NCT01024101
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : April 25, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date April 25, 2011
Study Start Date  ICMJE January 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ]
  • Safety: incidence and severity of adverse events, laboratory test abnormalities [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
Official Title  ICMJE Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
Brief Summary The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent head and neck cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Drug: Paclitaxel
Solution, IV, 100 mg/m², Weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
Other Names:
  • Taxol
  • BMS-181339
Study Arms  ICMJE Experimental: Paclitaxel
Intervention: Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with locally advanced head and neck cancer pretreated with surgery and/or radiotherapy and not suitable for further radical local treatment or patients with distant metastases who may have received no or one chemotherapy regimen

Exclusion Criteria:

  • Patients with serious, uncontrolled medical illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024101
Other Study ID Numbers  ICMJE CA139-372
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2011

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