Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Studying samples of tumor tissue, blood, and urine in the laboratory from patients receiving erlotinib may help doctors predict how patients will respond to treatment.

PURPOSE: The phase II trial is studying proteomic profiling to see how well it predicts response in patients receiving erlotinib for stage IIIB, stage IV, or recurrent non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Carboplatin; Erlotinib Hydrochloride; Paclitaxel

Criteria

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