- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00609804
Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib
10. mars 2016 oppdatert av: SCRI Development Innovations, LLC
Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib
This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
53
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Florida Cancer Specialists
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Georgia
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Gainesville, Georgia, Forente stater, 30501
- Northeast Georgia Medical Center
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Marietta, Georgia, Forente stater, 30060
- Wellstar Cancer Research
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Indiana
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Terre Haute, Indiana, Forente stater, 47802
- Providence Medical Group
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Kentucky
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Louisville, Kentucky, Forente stater, 40207
- Norton Cancer Institute
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70806
- Hematology Oncology Clinic, LLP
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Maryland
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Bethesda, Maryland, Forente stater, 20817
- Center For Cancer And Blood Disorders
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Bethesda, Maryland, Forente stater, 20817
- National Capital Clinical Research Consortium
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Mississippi
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Jackson, Mississippi, Forente stater, 39202
- Jackson Oncology Associates
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Missouri
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Chesterfield, Missouri, Forente stater, 63017
- St. Louis Cancer Care
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Kansas City, Missouri, Forente stater, 64132
- Research Medical Center
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Nebraska Methodist Cancer Center
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New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Hematology-Oncology Associates of Northern NJ
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- Chattanooga Oncology Hematology Associates
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Chattanooga, Tennessee, Forente stater, 37404
- Associates in Hematology Oncology
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Nashville, Tennessee, Forente stater, 37023
- Tennessee Oncology, PLLC
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Histologically confirmed stage IIIB/IV or relapsed non-small cell lung carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Patients with mixed tumors with small-cell elements are ineligible.
- Patients with no more than 2 prior lines of therapy, with the latest of those therapies being single-agent erlotinib.
- Evidence of progressive disease on erlotinib as assessed by the treating physician. Erlotinib must be the last treatment for NSCLC prior to enrollment into this study. Patients may be on erlotinib until enrollment. If erlotinib has already been stopped, the period of time off Erlotinib cannot exceed 14 days prior to study enrollment.
- Patients must have experienced a clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) from prior therapy with erlotinib for a period of 8 weeks.
- Patient must have one measurable lesion measuring at least 10 mm in the longest diameter (LD) by spiral computed tomography (CT), or 20 mm with conventional techniques according to the Response Evaluation Criteria in Solid Tumors (RECIST).
- Recovery from any toxic effects of erlotinib to ≤ grade 1 per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- Completion of palliative radiation therapy prior to the start of study treatment. Previously irradiated lesions in the advanced setting cannot be included as target lesions unless clear tumor progression has been observed following the completion of radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Absolute neutrophil count (ANC) >=1,500 and platelets >=75,000 (within 7 days prior to initial study treatment).
- Hemoglobin >=9 g/dL (within 7 days prior to initial treatment).
- International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution if not on anticoagulation therapy. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate with the therapeutic range established prior to study treatment initiation.
- Serum creatinine <=1.5 x institutional upper limit of normal (ULN) within 7 days prior to initial study treatment. If the absolute value is greater than 2mg/dL, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >=45 mL/min to be eligible.
- Bilirubin <=1.5 x the ULN; transaminases <=3 x institutional ULN, except in known hepatic metastasis, wherein these may be >=5 x institutional ULN.
- Patients must be able to understand the nature of this study, give written informed consent, and comply with study requirements.
- Agreement of male patients (with partners of childbearing potential) and female patients of childbearing potential to use effective contraception to prevent pregnancy during treatment and for a minimum of 90 days thereafter. Additionally, women should not breastfeed during this time.
Exclusion Criteria:
- Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone, and a disease-free survival (DFS) >=3 years.
- Pregnancy or lactation. All females of child-bearing potential must have negative serum or urine pregnancy tests within 7 days prior to study treatment.
- Prior epithelial growth factor receptor (EGFR) inhibitors, with the exception of erlotinib, are not allowed. This includes both tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. Prior vascular endothelial growth factor (VEGF) inhibitors, with the exception of bevacizumab, are not allowed.
Significant cardiac disease within 90 days of starting study treatment including:
- superior vena cava syndrome
- new onset angina
- congestive heart failure (CHF) > Class 2 per New York Heart Association (NYHA) classification
- arrhythmia
- valvular heart disease.
- Myocardial infarction within 6 months prior to initiation of study treatment
- Cardiomegaly on chest imaging or ventricular hypertrophy on electrocardiogram (ECG) unless the left ventricular ejection fraction (LVEF) is within normal range for the institution.
- Poorly controlled hypertension (defined as systolic blood pressure [BP] >150 mm Hg and/or diastolic BP >100 mm Hg on antihypertensive medications).
- Unstable angina (anginal symptoms at rest).
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
- A serious active infection (> grade 2) at the time of treatment
- A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- Untreated brain metastases. Patients who have treated metastases >=4 weeks out (with surgery and/or radiation therapy) and no evidence of central nervous system (CNS) progression are eligible.
- Treatment with a non-approved or investigational drug within 28 days of initial study treatment.
- A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment or anticipation of need for major surgery during the course of the study.
- Thrombolic or embolic events such as a stroke and transient ischemic attack (TIA) within the past 6 months.
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- Pulmonary hemorrhage/bleeding event >= grade 2 within 28 days of initial study treatment.
- Any other non-pulmonary hemorrhage/bleeding event >= grade 3 within 28 days of initial study treatment.
- Evidence or history of bleeding diathesis or coagulopathy.
- Serious non-healing wound, ulcer, or bone fracture.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
- Any malabsorption problem.
- Any condition that impairs the patient's ability to swallow whole pills.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Sorafenib+Erlotinib
Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth
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Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days.
Patients will be re-staged every 2 treatment cycles (every 8 weeks).
Patients with an objective response or stable disease will continue study treatment.
Patients will continue until disease progression or intolerable toxicity occurs.
Andre navn:
Erlotinib 150 mg once daily by mouth
Andre navn:
|
Aktiv komparator: Sorafenib
Sorafenib 400 mg twice daily by mouth.
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Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days.
Patients will be re-staged every 2 treatment cycles (every 8 weeks).
Patients with an objective response or stable disease will continue study treatment.
Patients will continue until disease progression or intolerable toxicity occurs.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Progression-free Survival (PFS)
Tidsramme: 18 months
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The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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18 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall Response Rate
Tidsramme: 18 months
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The Number of Patients Who Experience an Objective Benefit From Treatment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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18 months
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Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Tidsramme: 18 months
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Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0
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18 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: David Spigel, M.D., SCRI Development Innovations, LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2008
Primær fullføring (Faktiske)
1. mai 2012
Studiet fullført (Faktiske)
1. november 2014
Datoer for studieregistrering
Først innsendt
24. januar 2008
Først innsendt som oppfylte QC-kriteriene
24. januar 2008
Først lagt ut (Anslag)
7. februar 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. april 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Proteinkinasehemmere
- Erlotinib hydroklorid
- Sorafenib
Andre studie-ID-numre
- SCRI LUN 162
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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