A Pilot Study to Determine if Downstream Markers of EGFR Linked Signaling Pathways Predict Response to OSI-774 (Erlotinib) in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

Date de début de l'étude : 1 septembre 2004

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 \< 1.5 mg/dL or a creatinine clearance of \> 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