Phase II Study as First Line Treatment for Patients With Advanced Non-Small Cell Lung Cancer
- Histologically or cytologically documented stage IIIB or IV NSCLC
- Measurable disease
- ECOG performance status of 0-1
- Asymptomatic brain metastasis; must have completed radiotherapy/radiosurgery at least
2 weeks prior to enrollment and be off steroids.
- Radiotherapy must have been completed > 2 weeks prior to enrollment and patients must
have recovered from adverse events of radiotherapy.
- >/= 18 years of age
- Adequate hematologic function: absolute neutrophil count (ANC) >/= 1,500/mm3;
platelets >/= 100,000/mm3.
- Adequate hepatic function: total bilirubin = 1.5 X upper limit of normal (ULN); AST
and ALT = 2.5 X ULN.
- Adequate renal function: serum creatinine = 1.5mg/dL or creatinine clearance >/=
50cc/minute if serum creatinine > 1.5
- Signed an approved informed consent for this protocol and an approved informed
consent for Health Insurance Portability and Accountability Act (HIPAA)
- EGFR status by immunohistochemistry (IHC) if sufficient tissue is available
- Women of childbearing potential who have a positive pregnancy test at enrollment or
within 7 days of treatment. In addition, men enrolled on this study should
understand the risks to any sexual partner of childbearing potential and should
practice an effective method of birth regulation/control. Note: Patients are
considered to not be of childbearing potential if they are surgically sterile (they
have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
or they are postmenopausal.
- Patients who have had prior malignancy, except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
patient has been disease-free for 3 years.
- Patients with significant history of cardiac disease, i.e., uncontrolled
hypertension, unstable angina, uncontrolled congestive heart failure, myocardial
infarction within the past year, cardiomyopathy with decreased ejection fraction, or
cardiac ventricular arrythmias within the last year requiring new treatment .
- Patients with an uncontrolled seizure disorder, or active neurological disease.
- Patients with symptomatic brain metastasis.
- Patients who have received prior systemic chemotherapy.
- Patients who have received prior cetuximab or other therapy which specifically and
directly targets the EGF pathway.
- Prior infusion reaction to a monoclonal antibody or prior hypersensitivity to
- Patients with known peripheral neuropathy (> grade 1).