Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01024101
First received: November 30, 2009
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Head and Neck Cancer
 Drug: Paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent 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:
  • 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 ] [ Designated as safety issue: No ]
  • Safety: incidence and severity of adverse events, laboratory test abnormalities [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: 36
Study Start Date: January 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel 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

  Eligibility
Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01024101

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
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://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: NCT01024101     History of Changes
Other Study ID Numbers: CA139-372
Study First Received: November 30, 2009
Last Updated: April 8, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
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 February 27, 2015