- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01099358
Study in Advanced Solid Tumors
Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Cisplatin in Patients With Advanced Solid Tumors
The primary purpose of this study is to help answer the following research question(s):
- To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken in combination with cisplatin [pharmacokinetic (PK) analysis]
- To see if any drug interactions occur between cetuximab and cisplatin.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
London, Canadá, N6A 4L6
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
-
Toronto, Canadá, M5G 2M9
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
-
-
-
-
Arkansas
-
Fayetteville, Arkansas, Estados Unidos, 72703
- Highlands Oncology Group
-
-
Kansas
-
Fairway, Kansas, Estados Unidos, 66205
- University of Kansas Medical Center
-
-
Nevada
-
Reno, Nevada, Estados Unidos, 89502
- VA Sierra Nevada Health Care System
-
-
North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina
-
-
Texas
-
San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center - San Antonio
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The participant has histologically or cytologically advanced solid tumor that is resistant to standard therapy or for which there is no standard therapy.
- The participant has measurable or non-measurable disease.
- The participant has a life expectancy of greater than 3 months.
- The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (μL), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/μL.
- The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
- The participant has adequate renal function as defined by serum creatinine less than or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal to 60 mL/min for participants with creatinine levels above the ULN.
- The participant has the ability to understand, and the willingness to sign, a written informed consent document.
- If the participant has received prior therapy with platinum, the time to the first treatment of study drug from the last platinum exposure is >28 days.
Exclusion Criteria:
- The participant has symptomatic brain or leptomeningeal metastasis.
- The participant has not recovered from Adverse Events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
- The participant is receiving any other investigational agent(s).
- The participant is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiation therapy (RT), chemoembolization, or targeted therapy. Participants receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.
- The participant is receiving therapy with immunosuppressive agents.
- The participant has known drug or alcohol abuse.
- The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg.
- The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or cisplatin.
- The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
- The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
- The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [β-HCG] pregnancy test) or breastfeeding
- The participant has had a known positive test result for the human immunodeficiency virus.
- The participant has an active infection (requiring intravenous [IV] antibiotics), including tuberculosis.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Cetuximab and Cisplatin (D)
Cycle 1 (1 week, combination therapy): 400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1. 100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1. After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Administrado por vía intravenosa
Administered Intravenously
Administered Intravenously
|
Experimental: Cetuximab and Cisplatin (C)
Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Administrado por vía intravenosa
Administered Intravenously
Administered Intravenously
|
Experimental: Cetuximab on Cisplatin (B)
Cycle 1: 400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Administrado por vía intravenosa
Administered Intravenously
Administered Intravenously
|
Experimental: Cisplatin on Cetuximab (A)
Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Administrado por vía intravenosa
Administered Intravenously
Administered Intravenously
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Total Cisplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
Periodo de tiempo: Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).
|
Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).
|
Cetuximab Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)
Periodo de tiempo: Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).
|
Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).
|
Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
Periodo de tiempo: Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).
|
Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).
|
Cetuximab Pharmacokinetics: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)
Periodo de tiempo: Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).
|
Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).
|
Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)
Periodo de tiempo: Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).
|
Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).
|
Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)
Periodo de tiempo: Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).
|
Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).
|
Cetuximab Pharmacokinetics: Confirmatory Serum Concentration
Periodo de tiempo: Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion.
|
Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13418
- I4E-MC-JXBA (Otro identificador: Eli Lilly and Company)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Tumor solido
-
Aadi Bioscience, Inc.ReclutamientoTumor sólido avanzado | Tumor | Tumor SólidoEstados Unidos
-
Sorrento Therapeutics, Inc.RetiradoTumor solido | Tumor sólido en recaída | Tumor refractario
-
Memorial Sloan Kettering Cancer CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
-
RemeGen Co., Ltd.TerminadoTumor sólido metastásico | Tumor sólido localmente avanzado | Tumor sólido irresecableAustralia
-
Baodong QinReclutamientoTumor refractario | Tumor raroPorcelana
-
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyReclutamientoTumor Sólido, Adulto | Tumor refractarioEstados Unidos
-
Impact Therapeutics, Inc.ReclutamientoTumor solido | Tumor sólido avanzadoPorcelana, Taiwán, Estados Unidos, Australia
-
Partner Therapeutics, Inc.RetiradoTumor solido | Tumor Sólido, AdultoEstados Unidos
Ensayos clínicos sobre Cetuximab
-
University Medical Center GroningenUMC Utrecht; Erasmus Medical CenterReclutamientoCarcinoma de células escamosas de cabeza y cuello | Evaluación de margenPaíses Bajos
-
West China HospitalFirst Affiliated Hospital of Chongqing Medical UniversityReclutamientoCáncer colonrectal | Capecitabina | CetuximabPorcelana
-
Eben RosenthalNational Cancer Institute (NCI)TerminadoAdenocarcinoma de páncreasEstados Unidos
-
HiberCell, Inc.TerminadoCáncer colonrectalEstados Unidos, Puerto Rico, Alemania, Francia
-
Merck KGaA, Darmstadt, GermanyTerminadoCáncer colorrectal metastásico no tratado previamenteFrancia, Italia, Polonia, Alemania, Hong Kong, Austria, Brasil, Israel, Grecia, Argentina, Tailandia, Bélgica, Australia, México
-
Arbeitsgemeinschaft medikamentoese TumortherapieMerck Sharp & Dohme LLCTerminadoCáncer colorrectal metastásicoAustria
-
Cancer Institute and Hospital, Chinese Academy...Reclutamiento
-
Amsterdam UMC, location VUmcRadboud University Medical Center; University Medical Center GroningenTerminadoCáncer colorrectal metastásicoPaíses Bajos
-
Merck KGaA, Darmstadt, GermanyTerminadoCáncer de pulmón de células no pequeñas (CPCNP)Alemania
-
Poitiers University HospitalTerminadoCáncer de colon metastásicoFrancia