NCT00402545

Brief Summary

The purpose of this research study is to determine the safest and most effective dose of 5-FU that can be given with docetaxel (Taxotere), Cisplatin and cetuximab to patients with newly diagnosed locally advanced squamous cell carcinoma of the head and neck. We will also be studying the toxicity of this regimen of 4 drugs and the tumor response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

2.5 years

First QC Date

November 21, 2006

Last Update Submit

October 30, 2009

Conditions

Head and Neck Neoplasms

Keywords

SCCHNC-TPF5-FUsquamous cell carcinoma of the head and neck

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose (MTD) of Docetaxel/Cisplatin/5-Fluorouracil (TPF) induction chemotherapy when combined with cetuximab in an induction chemotherapy setting for locally advanced squamous cell cancer of the head and neck.

    2 years

Secondary Outcomes (2)

  • To asses toxicity of this combination

    2 years

  • To determine the response rate in this patient population.

    2 years

Interventions

CetuximabDRUG

Given intravenously on days 1, 8 and 15 of each 21-day cycle for three cycles

DocetaxelDRUG

Given intravenously on day 1 of each 21-day cycle for 3 cycles

Also known as: Taxotere
CisplatinDRUG

Intravenously on day 1 of each 21-day cycle for 3 cycles

5-FluorouracilDRUG

Given by continuous infusion pump over a period of 96 hours(dosage wil vary depending upon when participant enrolls in trial)

Also known as: 5-FU

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically proven squamous cell carcinoma of the head and neck.
  • Primary tumor sites eligible: oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx. Unknown primary SCC will also be eligible.
  • Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound or CAT scan.
  • At lease one uni- or bi-dimensionally measurable lesion by RECIST criteria.
  • years of age or older
  • ECOG performance status of 0-1
  • Adequate bone marrow, hepatic and renal functions as outlined in the protocol.

You may not qualify if:

  • Pregnant or breast feeding women
  • Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
  • Symptomatic peripheral neuropathy greater or equal to grade 2
  • Symptomatic altered hearing \> grade 2 by CIT-CTC criteria
  • Unstable cardiac disease despite treatment, myocardial infarction within 6 months
  • History of significant neurologic or psychiatric disorders including dementia or seizures
  • Active clinically significant uncontrolled infection
  • Active peptic ulcer disease defined as unhealed or clinically active
  • Hypercalcemia
  • Active drug addiction, including alcohol, cocaine or intravenous drugs use
  • Chronic Obstructive Pulmonary Disease
  • Autoimmune disease requiring therapy, prior organ transplant, or HIV infection
  • Interstitial lung disease
  • Involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
  • Concurrent treatment with any other cancer drug
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CetuximabDocetaxelCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Robert I Haddad, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 22, 2006

Study Start

January 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

US(1)