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:	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:

MedlinePlus related topics: Head and Neck Cancer

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 ]
Safety: incidence and severity of adverse events, laboratory test abnormalities [ Time Frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity ]

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 ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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


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

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms by Site Neoplasms Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic	Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017

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