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

12. maj 2017 opdateret af: Leora Horn, MD, Vanderbilt-Ingram Cancer Center

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

116

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-0232
        • University of Florida Shands Cancer Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory University
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0942
        • University of Michigan Comprehensive Cancer Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, Forenede Stater, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin
    • Texas
      • Houston, Texas, Forenede Stater, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
Andet: laboratoriebiomarkøranalyse
Blod- og vævsopsamling.
Medicin: bevacizumab
15 mg/m2 given through a vein for every 3 weeks
Medicin: carboplatin
AUC = 6 given through a vein on day 1 of each cycle.
Medicin: erlotinib hydrochloride
150 mg taken by mouth daily
Medicin: paclitaxel
200 mg/m2 given through a vein on day 1 of each cycle.
Genetisk: gene expression analysis
Blood and tissue collection.
Genetisk: protein expression analysis
Blood and tissue collection.
Genetisk: proteomic profiling
Blood and tissue collection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease
Tidsramme: End of treatment date
End of treatment date

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: End of treatment date
End of treatment date
Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride
Tidsramme: End of treatment date
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
Tidsramme: End of treatment date
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
Tidsramme: End of treatment date
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
Tidsramme: End of treatment date
End of treatment date
Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
Tidsramme: 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.
Through study completion, an average of 1 year
Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
Tidsramme: 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.
Through study completion, an average of 1 year
Number of Patients With Worst-grade Toxicities Per Grade
Tidsramme: 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
Through study completion, an average of 1 year
Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
Tidsramme: 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.
Through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt-Ingram Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: David Carbone, M.D., Ph.D., Vanderbilt-Ingram Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

26. oktober 2007

Først indsendt, der opfyldte QC-kriterier

26. oktober 2007

Først opslået (Skøn)

30. oktober 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VICC-THO-0640
  • P30CA068485 (U.S. NIH-bevilling/kontrakt)
  • VU-VICC-THO-0640
  • VU-VICC-070494

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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