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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 -5 years

Safety Issue:

Yes

Principal Investigator

Ezra Cohen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Univesity of Chicago Medical Center

Authority:

United States: Institutional Review Board

Study ID:

11588A

NCT ID:

NCT01185158

Start Date:

May 2002

Completion Date:

November 2010

Related Keywords:

  • Head and Neck Cancer
  • Larynx
  • Lip
  • Oral Cavity and Pharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

The University of Chicago Medical CenterChicago, Illinois  60637-1470