A Phase II Study of 250-mg ZD1839 Monotherapy in Recurren... | NCT01185158

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

NCT01185158

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

46Actual

Phase

Phase 2

Conditions

Head and Neck Cancer

Interventions

ZD1839 (IRESSA)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Aug 2004Actual

Completion Date

Nov 2010Actual

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 18, 2010

First Posted Date

Aug 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Label	Type	Description	Intervention Names
ZD1839 (IRESSA) 250mg	Experimental	ZD1839(IRESSA) 250mg orally (po) daily	Drug: ZD1839 (IRESSA)

Name	Type	Description	Arm Group Labels	Other Names
ZD1839 (IRESSA)	Drug	ZD1839: 250mg/day po or via g-tube Q 24 hours	ZD1839 (IRESSA) 250mg

Outcomes Module

Primary Outcomes

Measure	Description	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.		2 -5 years

Secondary Outcomes

Measure	Description	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.		2-5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006258	Head and Neck Neoplasms
D007818	Laryngeal Diseases
C562489	Lymphoid Interstitial Pneumonia

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds