NCT01185158

Brief Summary

The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's squamous cell head and neck cancer. The research is being done because currently no effective treatment exists for metastatic (spread of cancer cells from one area of the body to another) or recurrent squamous cell cancer of the head and neck. The purpose of this study is to find out if ZD1839 can shrink tumors or cause tumors to stop growing for a period of time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

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

Timeline
Completed

Started May 2002

Longer than P75 for phase_2 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

May 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

August 17, 2010

Last Update Submit

November 27, 2023

Conditions

Head and Neck Cancer

Keywords

LarynxLipOral Cavity and Pharynx

Outcome Measures

Primary Outcomes (1)

  • To assess the activity of 250mg of ZD1839 administered as a single agent to patients with recurrent or metastatic or both recurrent and metastatic head and neck cancer.

    2 -5 years

Secondary Outcomes (1)

  • To demonstrate the effectiveness of ZD 1839 as an inhibitor of epithelial growth factor (EGFR) phosphorylation, MAP kinase activation, and vascular endothelial growth (VEGF) secretion in metastatic head and neck cancer.

    2-5 years

Study Arms (1)

ZD1839 (IRESSA) 250mg

EXPERIMENTAL

ZD1839(IRESSA) 250mg orally (po) daily

Drug: ZD1839 (IRESSA)

Interventions

ZD1839 (IRESSA)DRUG

ZD1839: 250mg/day po or via g-tube Q 24 hours

ZD1839 (IRESSA) 250mg

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 head and neck incurable by surgery or radiation
  • Patients must have measurable disease, defined as at least on e lesion that can be accurately measured in the one dimension (longer diameter to be recorded) as greater then or equal to 20mm with conventional techniques or as greater than or equal to 10mm with computed tomograpy (CT) scan.
  • Therapeutic history that includes the Following:
  • No prior EGFR-based therapy for recurrent disease
  • No chemotherapy or irradiation with the 28-day period preceding entry to the study
  • Eastern Cooperative Oncology Group (ECOG)performance Status 0-2 (kamofsky \>59%)
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes \>3,000ml
  • absolute neutrophil count 1,500/ml
  • platelets 100,000/ml
  • total bilirubin within normal institutional limits
  • AST(SGOT)ALT(SGPT) \<2.5 X institutional upper limits of normal
  • Creatinine \<1.5

You may not qualify if:

  • Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical in situ.
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, ketoconazole, erythromycin, clarithromycin, atorvastatin, cimetidine, ametidine, amitriptyline, imipramine, verpamil, tamoxifen, chlorpromazine, amiodorone, chloroquine, St. John's Wort
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • Incomplete healing from previous oncologic or other major surgery Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compound of similar chemical or biologic composition to ZD 1839
  • Uncontrolled intercurrent illness
  • Pregnancy or breast feeding (women of child -bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60653, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsLaryngeal DiseasesLymphoid Interstitial Pneumonia

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ezra Cohen, M.D.

    The Univesity of Chicago Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

May 1, 2002

Primary Completion

August 1, 2004

Study Completion

November 1, 2010

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

US(1)