Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Exclusion Criteria

• •Renal insufficiency (serum creatinine \>2mg/dl)
• •Liver insufficiency (serum total bilirubin \>1.5X ULN, or serum transaminases \> 2.5X the ULN or %X ULN if hepatic metastases).
• •hematologic abnormality platelets\< 100,000 ANC \<1,500/mm3
• •THerapeutic anticoagulation will be allowed, but patients receiving fulvestrant while on therapeutic anticoagulation will have the fulvestrant dose divided into twice as many syringes to minimize the volume of intramuscular injection in these patients. In patients receiving low molecular weight heparin or fondaparinux, these medications should be held for 12 hours before and after fulvestrant injection if possible.
• •Active CNS metastases.
• •New York Heart Association class III or IV cardiac disease
• •myocardial infarction within the past 12 months
• •symptomatic ventricular arrhythmia
• •symptomatic conduction abnormality
• •evidence of clinically active interstitial lung disease
• •Patients with asymptomatic chronic stable radiographic changes are eligible
• •pregnant or nursing or inadequate contraception
• •hypersensitivity to erlotinib hydrochloride or fulvestrant or to any of their excipients
• •comorbid disease or medical condition that would preclude study treatment or compliance
• •malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• •chemotherapy or non-cytotoxic investigational agents within 4 weeks of initiating treatment.
• •major surgery within 4 weeks of initiating therapy. Minor surgery within 7 days of initiating therapy.
• •anticancer antiestrogen therapy. Concurrent stable-dose steroids allowed
• •concomitant radiation therapy to the lungs. Radiation therapy to non-target lesions will be allowed as long as it is completed 1 week prior to initiation of treatment.
• •prior anticancer epidermal growth factor receptor inhibitors
• •concurrent CYP3A4 inducers, including any of the following:
• •Phenytoin
• •Carbamazepine
• •Rifampin
• •Barbiturates
• •Hypericum perforatum (St. John's wort)