NCT00337532

Brief Summary

The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started May 2005

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

Geographic Reach
1 country

2 active sites

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

May 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 4, 2010

Status Verified

June 1, 2008

Enrollment Period

2.1 years

First QC Date

June 14, 2006

Last Update Submit

February 2, 2010

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.

Secondary Outcomes (1)

  • Toxicity for maximum 3 cycles

Study Arms (1)

paclitaxel-cisplatin combination regimen

ACTIVE COMPARATOR
Drug: PaclitaxelDrug: cisplatin

Interventions

PaclitaxelDRUG

Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.

paclitaxel-cisplatin combination regimen
cisplatinDRUG

solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.

paclitaxel-cisplatin combination regimen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced, Stage II-IV (except M1), hand and neck cancer
  • \> = 1 measurable lesion
  • not been previously treated for head and neck cancer

You may not qualify if:

  • history of another malignancy
  • organ allografts
  • pre-exiting neuropathy \> = CTC grade 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Insitution

Seoul, South Korea

Location

Local Institution

Seoul, South Korea

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

PaclitaxelCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

May 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 4, 2010

Record last verified: 2008-06

Locations

KR(2)