Clinical trial NCT01185158: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Larynx
Lip
Oral Cavity and Pharynx
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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.
timeFrame: 2 -5 years
Secondary outcomes:
measure: 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.
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: The Univesity of Chicago Medical Center
name: Ezra Cohen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: