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

NCT ID: NCT01185158

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZD1839 (IRESSA) 250mg

ZD1839(IRESSA) 250mg orally (po) daily

Group Type EXPERIMENTAL

ZD1839 (IRESSA)

Intervention Type DRUG

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

Interventions

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ZD1839 (IRESSA)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ezra Cohen, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Univesity of Chicago Medical Center

Locations

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The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Related Links

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http://uccrc.uchicago.edu

The University of Chicago Comprehensive Cancer Center Web page

Other Identifiers

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11588A

Identifier Type: -

Identifier Source: org_study_id