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

Bristol-Myers Squibb36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

PaclitaxelDRUG

Solution, IV, 100 mg/m², Weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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