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Trial record 18 of 24 for:    "Adenosquamous Lung Carcinoma" | "Antineoplastic Agents, Phytogenic"

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

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ClinicalTrials.gov Identifier: NCT00550537
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : April 25, 2017
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date  ICMJE October 26, 2007
First Posted Date  ICMJE October 30, 2007
Results First Submitted Date  ICMJE March 14, 2017
Results First Posted Date  ICMJE April 25, 2017
Last Update Posted Date June 8, 2017
Study Start Date  ICMJE October 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2010)
Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease [ Time Frame: End of treatment date ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2007)
Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease
Change History Complete list of historical versions of study NCT00550537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • 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 [ Time Frame: End of treatment date ]
  • Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride [ Time Frame: End of treatment date ]
  • Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment [ Time Frame: End of treatment date ]
    End of treatment date
  • Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers [ Time Frame: End of treatment date ]
  • 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 [ Time Frame: End of treatment date ]
  • Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC [ Time Frame: Through study completion, an average of 1 year ]
    Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. The response rate is calculated as the percentage of PR+CR among patients assessed for response.
  • Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC [ Time Frame: Through study completion, an average of 1 year ]
    PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B. For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date). The median survival time and 95% confidence interval were estimated using Kaplan-meier method.
  • Number of Patients With Worst-grade Toxicities Per Grade [ Time Frame: Through study completion, an average of 1 year ]
    The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) - Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B). Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
  • Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC [ Time Frame: Through study completion, an average of 1 year ]
    The overall survival time is defined as the time from on treatment to death. Patients were censored of they were alive at the last follow up date. The median survival time and its confidence interval were estimated using Kaplan-meier method.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2007)
  • 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
  • Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride
  • Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment
  • Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers
  • 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
  • Response rate
  • Progression-free and overall survival
  • Safety profile
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Official Title  ICMJE A Feasibility Study Investigating Translational Science in Chemotherapy-Naive Patients With Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Treated With the EGFR-TKI, Erlotinib
Brief 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.

Detailed Description

OBJECTIVES:

Primary

  • To define a pre-treatment tumor proteomic profile that predicts response, stable disease, or progressive disease in patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer treated with erlotinib hydrochloride.

Secondary

  • To test and refine a pre-treatment serum proteomic expression pattern that predicts response to erlotinib hydrochloride and/or carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride.
  • To test and refine tumor proteomic profiles that predict response to carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride.
  • To analyze individual and pattern(s) of erlotinib hydrochloride-induced genomic and proteomic biomarker changes in relation to response or non-response to treatment.
  • To correlate the efficacy and toxicity of erlotinib hydrochloride with expression of EGFR, EGFR pathway, ErbB family, and other related biomarkers.
  • To determine 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.
  • To estimate response rate and progression-free and overall survival of patients treated with erlotinib hydrochloride as initial therapy.
  • To characterize the safety profile of erlotinib hydrochloride in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily until disease progression.

At the time of disease progression, patients receive standard chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Patients with non-squamous cell non-small cell lung cancer also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses.

Tumor tissue, plasma, serum, and urine samples are collected at baseline for proteomics analysis.

After the completion of study treatment, patients are followed every 8 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: bevacizumab
    15 mg/m2 given through a vein for every 3 weeks
  • Drug: carboplatin
    AUC = 6 given through a vein on day 1 of each cycle.
  • Drug: erlotinib hydrochloride
    150 mg taken by mouth daily
  • Drug: paclitaxel
    200 mg/m2 given through a vein on day 1 of each cycle.
  • Genetic: gene expression analysis
    Blood and tissue collection.
  • Genetic: protein expression analysis
    Blood and tissue collection.
  • Genetic: proteomic profiling
    Blood and tissue collection.
  • Other: laboratory biomarker analysis
    Blood and tissue collection.
Study Arms  ICMJE Experimental: Treatment
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
Interventions:
  • Drug: bevacizumab
  • Drug: carboplatin
  • Drug: erlotinib hydrochloride
  • Drug: paclitaxel
  • Genetic: gene expression analysis
  • Genetic: protein expression analysis
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2017)
116
Original Enrollment  ICMJE
 (submitted: October 26, 2007)
210
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00550537
Other Study ID Numbers  ICMJE VICC-THO-0640
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0640
VU-VICC-070494
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leora Horn, MD, Vanderbilt-Ingram Cancer Center
Study Sponsor  ICMJE Vanderbilt-Ingram Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: David Carbone, M.D., Ph.D. Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP