NCT00033449

Brief Summary

This phase I trial is studying the side effects and best dose of gefitinib when given together with radiation therapy with or without cisplatin in treating patients with stage III or stage IV head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy with cisplatin may kill more tumor cells

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

8.2 years

First QC Date

April 9, 2002

Last Update Submit

January 24, 2013

Conditions

Stage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the Oropharynx

Outcome Measures

Primary Outcomes (3)

  • Incidence of grade 4 or greater mucositis as scored by the National Cancer Institute (NCI) Common Toxicity Criteria v2.0

    Descriptive statistics (mean, median, range, standard deviation \[s.d.\], percentage, as appropriate) will be obtained.

    Up to 2 years

  • Incidence of grade 4 or greater skin toxicity as scored by the NCI Common Toxicity Criteria v2.0

    Descriptive statistics (mean, median, range, s.d., percentage, as appropriate) will be obtained.

    Up to 2 years

  • Incidence of any other grade 4 or greater toxicity as scored by the NCI Common Toxicity Criteria v2.0

    Descriptive statistics (mean, median, range, s.d., percentage, as appropriate) will be obtained.

    Up to 2 years

Secondary Outcomes (5)

  • Primary tumor response rate as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)

    8 weeks

  • Response rates as assessed by the RECIST

    Up to 5 years

  • Relapse-free survival rates

    Up to 5 years

  • Overall survival rates

    Up to 5 years

  • Biological effects of gefitinib within the primary tumor and skin

    Baseline

Study Arms (1)

Treatment (gefitinib, radiation therapy, cisplatin)

EXPERIMENTAL

See detailed description.

Drug: gefitinibRadiation: radiation therapyDrug: cisplatinOther: laboratory biomarker analysis

Interventions

gefitinibDRUG

Given orally

Also known as: Iressa, ZD 1839
Treatment (gefitinib, radiation therapy, cisplatin)
radiation therapyRADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Treatment (gefitinib, radiation therapy, cisplatin)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Treatment (gefitinib, radiation therapy, cisplatin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gefitinib, radiation therapy, cisplatin)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed locally advanced squamous cell carcinoma of the head and neck involving the oral cavity, oropharynx, hypopharynx, or supraglotticor glottic larynx
  • Unresectable disease
  • Medically inoperable resectable disease allowed
  • Stage III or IV
  • No distant metastases
  • Only patients with intermediate stage disease (T1-2, N1-N2a or T3, N0-1) are eligible for radiotherapy alone with gefitinib
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 6 months
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9 g/dL
  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Denver, Colorado, 80217-3364, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

GefitinibRadiotherapyRadiationCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeuticsPhysical PhenomenaChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • David Raben

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

February 1, 2002

Primary Completion

April 1, 2010

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)