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This study looks at whether proteomic profiling can predict response to treatment in patients with stage IIIB, stage IV or recurrent non-small cell lung cancer who receive erlotinib hydrochloride. People with histologically confirmed NSCLC who were willing to undergo biopsy procedures could take part. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following criteria: * Stage IIIB (with pleural effusion) or stage IV disease * Recurrent disease after prior surgery * Measurable or evaluable disease is desirable but not required * No untreated symptomatic brain metastases * Patients who are neurologically unstable despite radiotherapy for the brain metastases are not eligible * No requirement for steroids to control neurological symptoms PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 1.5 mg/dL * Normal hemostasis by history * PT/PTT within 0.5 seconds of normal range * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to undergo biopsy procedures * No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients of this product * No other concurrent malignancies or malignancies diagnosed within the past 5 years, except basal cell carcinoma or cervical cancer in situ * No significant cardiac disease, including any of the following: * NYHA class III or IV heart disease * Uncontrolled dysrhythmia * Myocardial infarction within the past 6 months * No evidence of clinically active interstitial lung disease * Chronic stable radiographic changes that are asymptomatic allowed * No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial * No uncontrolled hypertension * Blood pressure must be ≤ 150/90 mmHg on a stable antihypertensive regimen PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 months since prior adjuvant chemotherapy * No unresolved chronic toxicity \> CTC grade 2 from prior anticancer therapy (except alopecia) * More than 30 days since prior non-approved or investigational drugs * No prior chemotherapy for advanced NSCLC * No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or St. John's wort * No concurrent administration of other drugs known to inhibit EGFR * No other concurrent anti-neoplastic or anti-tumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy * No other concurrent investigational agents * Concurrent cardioprotective doses of aspirin, as recommended by the physician, for cardiovascular disease allowed