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Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

24 november 2015 bijgewerkt door: Eli Lilly and Company

Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

72

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital
    • Newfoundland and Labrador
      • Grand Falls-Windsor, Newfoundland and Labrador, Canada, A2A 2E2
        • Local Institution
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2N1
        • The Credit Valley Hospital
      • Sudbury, Ontario, Canada, P3E 5J1
        • Sudbury Regional Hospital
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre (Regional Cancer Care)
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre De Sante Et De Services Sociaux De Rimouski-Neigette
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine (Caimed Center)
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego
  • Verenigde Staten
    • Arizona
      • Casa Grande, Arizona, Verenigde Staten, 85122
        • Donald W. Hill M.D., P.C.
    • California
      • Beverly Hills, California, Verenigde Staten, 90211
        • Beverly Hills Cancer Center
      • Los Angeles, California, Verenigde Staten, 90036
        • Cancer Care Institute
      • Oakland, California, Verenigde Staten, 94609
        • Northern California Hematology & Oncology
      • San Diego, California, Verenigde Staten, 92123
        • Sharp Clinical Oncology Research
    • Florida
      • Ft. Lauderdale, Florida, Verenigde Staten, 33308
        • Broward Oncology Associates, P.A.
      • Miami, Florida, Verenigde Staten, 33125
        • Elite Research Institute
    • Illinois
      • Skokie, Illinois, Verenigde Staten, 60076
        • Edward H. Kaplan, MD & Associates
    • Minnesota
      • Edina, Minnesota, Verenigde Staten, 55435
        • Fairview Southdale Medical Oncology Clinic
    • North Dakota
      • Bismarck, North Dakota, Verenigde Staten, 58501
        • Mid Dakota Clinic, PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19140
        • Temple University Hospital
    • Texas
      • Lubbock, Texas, Verenigde Staten, 79415
        • University Medical Center
    • Washington
      • Kennewick, Washington, Verenigde Staten, 99336
        • Columbia Basin Hematology and Oncology

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
  • Evaluable or measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

  • Uncontrolled Central Nervous System (CNS) metastasis.
  • Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
  • Concurrent malignancy
  • Prior chemotherapy for NSCLC
  • Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
  • Superior vena cava syndrome contra-indicating hydration
  • White Blood Cells (WBC) < 3,000/mm³
  • Absolute neutrophile count (ANC) < 1,500/mm³
  • Platelet < 100,000/mm³
  • Hemoglobin (Hgb) < 9.0 g/dL
  • Total bilirubin > 1.5 x Upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) > 5.0 x ULN.
  • Serum creatinine >1.25 x ULN and calculated creatinine clearance <60mL/min

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cetuximab + Cisplatin + Vinorelbine
Geneesmiddel: Cetuximab
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
Andere namen:
  • Erbitux
  • BMS-564717
Geneesmiddel: Cisplatin
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
Andere namen:
  • Platina
Geneesmiddel: Vinorelbine
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
Andere namen:
  • Navelbine

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Tijdsspanne: Day 1 up to 30 days after last dose
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
Tijdsspanne: Day 1 to 30 days after last dose
Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Day 1 to 30 days after last dose
Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
Tijdsspanne: Day 1 up to 30 days after last dose
ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN. Albumin (low) Grade 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Grade 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Grade 3: < 2 g/dL to <2 g/L. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Hematology Laboratory Abnormalities - Treated Population
Tijdsspanne: Day 2 up to 30 days after last dose
Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10^9/μL.
Day 2 up to 30 days after last dose
Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
Tijdsspanne: Day 1 up to 30 days after last dose
ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 - 155 mmol/L; Gr 3: >155 - 160mmol/L; Gr 4: >160 mmol/L. Sodium low(L) Gr 1:<LLN - 130mmol/L; Gr 3: <130 - 120 mmol/L; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN - 5.5 mmol/L; Gr 2: >5.5 - 6.0 mmol/L; Gr 3: > 6.0 - 7.0 mmol/L; Gr 4: >7.0 mmol/L. Potassium (L) Gr 1: <LLN - 3.0 mmol/L; Gr 2: <LLN - 3.0 mmol/L; Gr 3: < 3.0 - 2.5 mmol/L; Gr 4: <2.5 mmol/L. Serum creatinine (H) Gr 1: >1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
Tijdsspanne: Day 1 up to 30 days after last dose
Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship. AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.
Day 1 up to 30 days after last dose
Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
Tijdsspanne: Day 1 up to 30 days after last dose
Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship. Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0). Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less. Day 1=start of study drug; to 30 days after last dose of any treatment.
Day 1 up to 30 days after last dose

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Eli Lilly and Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2010

Primaire voltooiing (Werkelijk)

1 september 2012

Studie voltooiing (Werkelijk)

1 september 2012

Studieregistratiedata

Eerst ingediend

22 april 2010

Eerst ingediend dat voldeed aan de QC-criteria

22 april 2010

Eerst geplaatst (Schatting)

23 april 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

24 december 2015

Laatste update ingediend die voldeed aan QC-criteria

24 november 2015

Laatst geverifieerd

1 november 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CA225-346

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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