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


Phase 2
20 Years
74 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Each 49 day course of treatment until withdrawal or unacceptable toxicity

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CA139-372

NCT ID:

NCT01024101

Start Date:

January 2004

Completion Date:

December 2005

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

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