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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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ZD1839 (IRESSA)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Larynx, Lip, Oral Cavity and Pharynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZD1839 (IRESSA) 250mg

Arm Description

ZD1839(IRESSA) 250mg orally (po) daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 17, 2010
Last Updated
January 16, 2014
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01185158
Brief Title
A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma
Official Title
A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Larynx, Lip, Oral Cavity and Pharynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZD1839 (IRESSA) 250mg
Arm Type
Experimental
Arm Description
ZD1839(IRESSA) 250mg orally (po) daily
Intervention Type
Drug
Intervention Name(s)
ZD1839 (IRESSA)
Intervention Description
ZD1839: 250mg/day po or via g-tube Q 24 hours
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ezra Cohen, M.D.
Organizational Affiliation
The Univesity of Chicago Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60653
Country
United States

12. IPD Sharing Statement

Links:
URL
http://uccrc.uchicago.edu
Description
The University of Chicago Comprehensive Cancer Center Web page

Learn more about this trial

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

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