NCT01024101

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_2 head-and-neck-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

Enrollment Period

1.9 years

First QC Date

November 30, 2009

Last Update Submit

April 8, 2011

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Paclitaxel

EXPERIMENTAL
Drug: Paclitaxel

Interventions

PaclitaxelDRUG

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

Also known as: Taxol, BMS-181339
Paclitaxel

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with serious, uncontrolled medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

PaclitaxelBMS 181339

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

January 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

April 25, 2011

Record last verified: 2011-04