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

The University of Chicago

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: ZD1839 (IRESSA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01185158

11588A

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No 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