NCT00185835

Brief Summary

To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck. To study the effects of ZD1839 combined with either cisplatin or radiotherapy on signal transduction pathway gene expression in tumor cells in patients with local-regional recurrent squamous cell cancer of the head and neck using micro array analysis from tumor samples taken at the time of relapse and during treatment.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 head-and-neck-cancer

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

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Last Updated

March 29, 2010

Status Verified

March 1, 2010

Enrollment Period

4.1 years

First QC Date

September 12, 2005

Last Update Submit

March 25, 2010

Conditions

Head and Neck CancerCarcinoma, Squamous Cell

Outcome Measures

Primary Outcomes (1)

  • To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck

    no known

Secondary Outcomes (5)

  • To estimate the median and one-year disease-free and overall survival rates of the treated patients.

    one year

  • To determine the response rate, duration of response and duration of stable disease in these treated patients.

  • To identify and estimate the incidence rate of acute and late toxicities associated with combined ZD1839, chemotherapy and re-irradiation in patients with recurrent squamous cell cancer of the head and neck.

    no known

  • To determine the pattern of disease progression in recurrent disease patients treated with this regimen.

  • To assay EGFR pathway-related proteins by IHC and cDNA microarray, and to correlate their baseline expression, as well as changes in expression after therapy, with clinical endpoints including tumor remission and one-year survival.

    one year

Interventions

ZD-1839DRUG
CisplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • The recurrence or second primary must have defined bi- or uni-dimensional measurements.
  • Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
  • The patient must not be a candidate for complete surgical resection. The previous irradiation must not exceed a maximum of 75 Gy.
  • The entire tumor volume must be included in a treatment field that limits the total spinal cord dose to 50 Gy (prior RT and anticipated RT).
  • Patients must be at least 6 months from prior radiation therapy.
  • Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
  • Zubrod performance status 0-1.
  • Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or equal to 1.5 mg/dl within 2 weeks prior to registration.
  • LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
  • Must be able to submit previous radiation records, including simulation and portal films, in order to assure that cord tolerance is not exceeded.

You may not qualify if:

  • Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ZD1839 or other agents used in study.
  • Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

GefitinibCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Quynh-Thu Le

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

June 1, 2002

Primary Completion

July 1, 2006

Last Updated

March 29, 2010

Record last verified: 2010-03

Locations

US(1)