Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
- Registration Number
- NCT01024101
- Lead Sponsor
- Bristol-Myers Squibb
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Read More
Exclusion Criteria
- Patients with serious, uncontrolled medical illness
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Paclitaxel Paclitaxel -
- Primary Outcome Measures
Name Time Method 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 Each 49 day course of treatment until withdrawal or unacceptable toxicity Safety: incidence and severity of adverse events, laboratory test abnormalities Each 49 day course of treatment until withdrawal or unacceptable toxicity
- Secondary Outcome Measures
Name Time Method 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 Each 49 day course of treatment until withdrawal or unacceptable toxicity