A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma

November 27, 2023 updated by: University of Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60653
        • The University of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZD1839 (IRESSA) 250mg
ZD1839(IRESSA) 250mg orally (po) daily
Drug: ZD1839 (IRESSA)
ZD1839: 250mg/day po or via g-tube Q 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 2 -5 years
2 -5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 2-5 years
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Ezra Cohen, M.D., The Univesity of Chicago Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimated)

August 19, 2010

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11588A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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