CompletedPhase 2NCT00550537

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

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.

Checked against the public recordLast updated Jun 8, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations7
SponsorVanderbilt-Ingram Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Vanderbilt-Ingram Cancer Center
Interventions being studied
Drug: bevacizumab; Drug: carboplatin; Drug: erlotinib hydrochloride; Drug: paclitaxel; Genetic: gene expression analysis; Genetic: protein expression analysis; Genetic: proteomic profiling; Other: laboratory biomarker analysis
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Florida Shands Cancer CenterGainesville, Florida
  • Emory UniversityAtlanta, Georgia
  • University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
  • Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee
  • Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee
  • Vanderbilt-Ingram Cancer CenterNashville, Tennessee
  • M. D. Anderson Cancer Center at University of TexasHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 8, 2017. Always confirm current availability with the study team.

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