erlotinib in treating patients with stage iiib, stage iv, or recurrent non-small cell lung cancer

Conditions: Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: this clinical trial is studying how well erlotinib works in treating patients with stage iiib, stage iv, or recurrent non-small cell lung cancer. erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

primary objectives: i. prospectively identify downstream markers of egfr linked signaling pathways that are predictive of response to osi-774 (erlotinib) in this population. secondary objectives: i. estimate antitumor objective response rate per recist. ii. estimate disease control rate (cr+pr+sd). iii. estimate time to progression and overall survival. iv. estimate if a grade 2 rash is a predictor of response to osi-774 (erlotinib) and of patient survival. v. assess safety profile of osi-774 (erlotinib) in this population. vi. to determine whether smoking status is linked to outcome for advanced nsclc patients treated with osi-774 (erlotinib). outline: this is a pilot, multicenter study. patients receive oral erlotinib once daily on days 1-28. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients complete the smoking status survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment. after completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years. projected accrual: a total of 129 patients will be accrued for this study within 6 months.

Eligibility criteria:
inclusion criteria: * patients must have pathologically confirmed nsclc * patients must have diagnostic specimen available on paraffin-embedded block * patients must have advanced nsclc (stage iiib with a malignant pleural effusion or iv disease, or recurrent disease) * patients must not have received prior chemotherapy or targeted therapy for metastatic disease, including no prior egfr inhibitor; patient may have received adjuvant chemotherapy for early stage disease (ib-iiia), or chemo/xrt for stage iiia or iiib disease, provided s/he meets all of the following: * it has been at least 6 months since completion of patient's adjuvant chemotherapy for early stage disease (ib-iiia) or chemo/xrt for stage iiia or iiib disease * patient now has advanced disease * patients must have measurable disease per recist criteria; all sites of disease must be assessed within 4 weeks prior to registration * creatinine \ 50 ml/min * sgot(ast) and sgpt(alt) \< 2 x the institution's upper limit of normal * bilirubin \< 1.5 mg/dl * anc \> 1500/mm\^3 * plt \> 100,000/mm\^3 * patients must have ecog performance status 0, 1, or 2 * patients with stable, treated brain metastases are eligible (defined as: patients with brain metastases must have been treated and are asymptomatic and are no longer taking corticosteroids) * patients with gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for iv alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease, are ineligible * pregnant and breast feeding women are excluded from the study because the agent used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk * women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) for the duration of the study * hiv positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with osi-774 (erlotinib) * patients must not have had immuno, hormonal or radiation therapy within 2 weeks prior to entering the study; those who have not recovered from adverse events due to agents administered more than 2 weeks earlier are ineligible; previously irradiated areas can be considered "measurable disease" if there has been documented progression * patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements * patients must not have serious non-healing wound, or bone fracture, or major surgical procedure within 21 days prior to study entry * patients taking warfarin are eligible * if the patient is taking cyp3a4 inducers or inhibitors, they must be discontinued one week prior to starting osi-774 (erlotinib) * patients must not be enrolled in any other concurrent clinical trials