- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01109524
Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
24 november 2015 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Casa Grande, Arizona, Förenta staterna, 85122
- Donald W. Hill M.D., P.C.
-
-
California
-
Beverly Hills, California, Förenta staterna, 90211
- Beverly Hills Cancer Center
-
Los Angeles, California, Förenta staterna, 90036
- Cancer Care Institute
-
Oakland, California, Förenta staterna, 94609
- Northern California Hematology & Oncology
-
San Diego, California, Förenta staterna, 92123
- Sharp Clinical Oncology Research
-
-
Florida
-
Ft. Lauderdale, Florida, Förenta staterna, 33308
- Broward Oncology Associates, P.A.
-
Miami, Florida, Förenta staterna, 33125
- Elite Research Institute
-
-
Illinois
-
Skokie, Illinois, Förenta staterna, 60076
- Edward H. Kaplan, MD & Associates
-
-
Minnesota
-
Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Medical Oncology Clinic
-
-
North Dakota
-
Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic, PC
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19140
- Temple University Hospital
-
-
Texas
-
Lubbock, Texas, Förenta staterna, 79415
- University Medical Center
-
-
Washington
-
Kennewick, Washington, Förenta staterna, 99336
- Columbia Basin Hematology and Oncology
-
-
-
-
New Brunswick
-
Moncton, New Brunswick, Kanada, E1C 6Z8
- The Moncton Hospital
-
-
Newfoundland and Labrador
-
Grand Falls-Windsor, Newfoundland and Labrador, Kanada, A2A 2E2
- Local Institution
-
-
Ontario
-
Mississauga, Ontario, Kanada, L5M 2N1
- The Credit Valley Hospital
-
Sudbury, Ontario, Kanada, P3E 5J1
- Sudbury Regional Hospital
-
Thunder Bay, Ontario, Kanada, P7B 6V4
- Thunder Bay Regional Health Sciences Centre (Regional Cancer Care)
-
Toronto, Ontario, Kanada, M4C 3E7
- Toronto East General Hospital
-
-
Quebec
-
Rimouski, Quebec, Kanada, G5L 5T1
- Centre De Sante Et De Services Sociaux De Rimouski-Neigette
-
-
-
-
-
Ponce, Puerto Rico, 00716
- Ponce School of Medicine (Caimed Center)
-
San Juan, Puerto Rico, 00927
- Fundacion de Investigacion de Diego
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Cetuximab + Cisplatin + Vinorelbine
|
Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
Andra namn:
Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
Andra namn:
Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2010
Primärt slutförande (Faktisk)
1 september 2012
Avslutad studie (Faktisk)
1 september 2012
Studieregistreringsdatum
Först inskickad
22 april 2010
Först inskickad som uppfyllde QC-kriterierna
22 april 2010
Första postat (Uppskatta)
23 april 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 december 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 november 2015
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Carcinom
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Antineoplastiska medel, immunologiska
- Vinorelbin
- Cetuximab
Andra studie-ID-nummer
- CA225-346
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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