NCT00195078

Brief Summary

The purpose of this study is to find out whether adding ZD1839 to standard treatment (Cisplatin and Radiation Therapy) of unresectable head and neck cancers is better than cisplatin and radiation alone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_1 head-and-neck-cancer

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 20, 2007

Status Verified

July 1, 2007

First QC Date

September 14, 2005

Last Update Submit

July 19, 2007

Conditions

Head and Neck Cancer

Keywords

head and neck cancersquamous cell carcinoma of the oral cavitysquamous cell carcinoma of the oropharynxsquamous cell carcinoma of the larynxsquamous cell carcinoma of the hypopharynx

Outcome Measures

Primary Outcomes (1)

  • To explore whether the addition of ZD1839 to standard treatment of unresectable head and neck cancers (i.e., cisplatin and radiation therapy) improves the clinical complete response rate (as measured by RECIST criteria).

Secondary Outcomes (3)

  • To determine the time to disease progression, duration of response, and 2?year disease-free survival in subjects with unresectable tumors of the head and neck after combined therapy with ZD1839, cisplatin, and radiation.

  • To determine the toxicities, and recovery from toxicities, of combined therapy with ZD1839, cisplatin, and radiation therapy.

  • To determine dose-limiting toxicity as well as the recommended Phase II dose of ZD1839 given concurrently with cisplatin and radiation.

Interventions

ZD1839 (IRESSA)DRUG
CisplatinDRUG
Radiation TherapyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. For the Phase II portion of the study: measurable disease as based on RECIST criteria.
  • Stage III or IV disease, M0.
  • Life expectancy \> 6 months.

You may not qualify if:

  • Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of squamous cell carcinoma of the skin or cervical cancer in situ.
  • Previous treatment with radiation, chemotherapy, or definitive surgical therapy.
  • Distant metastatic disease.
  • Documented evidence of HIV infection (because the interaction of ZD1839 with Highly Active Anti-Retroviral Therapy \[HAART\] is unknown).
  • Substance abuse or psychiatric problems that would interfere with compliance.
  • Pregnancy or breast-feeding (women of child-bearing potential).
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  • Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

GefitinibCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Roger Keresztes, M.D.

    Weill Medical College of Cornell University

    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

September 14, 2005

First Posted

September 19, 2005

Study Start

April 1, 2004

Study Completion

September 1, 2006

Last Updated

July 20, 2007

Record last verified: 2007-07

Locations

US(1)