Phase 2
Completed N=116
Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00550537 ↗Enrolled (actual)
116
Serious AEs
6.9%
Results posted
Apr 2017
Primary outcomePrimary: Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease |
— | — |
| SECONDARY Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride |
— | — |
| SECONDARY Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride |
— | — |
| SECONDARY Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment |
— | — |
| SECONDARY Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers |
— | — |
| SECONDARY Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy |
— | — |
| SECONDARY Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC |
18.8 | — |
| SECONDARY Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC |
3.16 | — |
| SECONDARY Number of Patients With Worst-grade Toxicities Per Grade |
18; 51; 15; 1 | — |
| SECONDARY Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC |
12.53; 17.23; 6.08 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00550537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.