- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02271464
Maintenance Bevacizumab Only or Bevacizumab Plus Metronomic Chemotherapy in Advanced Colorectal Cancer (MOMA)
Phase II Randomized Study of Maintenance Treatment With Bevacizumab or Bevacizumab Plus Metronomic Chemotherapy After First-line Induction FOLFOXIRI Plus Bevacizumab for Metastatic Colorectal Cancer Patients
This study consist of 4-months induction first-line chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab followed by maintenance with bevacizumab or bevacizumab plus metronomic chemotherapy (with capecitabine and cyclophosphamide) in mCRC patients.
The main objective of this study is to preliminarily evaluate the potential effects of the combination of a metronomic chemotherapy with capecitabine and cyclophosphamide to maintenance bevacizumab on pharmacodynamic and clinical parameters among mCRC patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Brescia, Italia, 25124
- Istituto Ospedaliero Fondazione Poliambulanza Di Brescia
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Brescia, Italia, 25125
- Pres.Ospedaliero Spedali Civili Brescia
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Cremona, Italia, 26100
- Istituti Ospitalieri di Cremona
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Cuneo, Italia, 12100
- Azienda Ospedaliera S. Croce E Carle Di Cuneo
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Ferrara, Italia, 44100
- A.O. Universitaria Arcispedale S.Anna Di Ferrara
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Frosinone, Italia, 03100
- Ausl Di Frosinone -
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Genova, Italia, 16128
- E.O. Ospedali Galliera
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Legnago, Italia, 37045
- Ospedale Per Acuti Mater Salutis Di Legnago
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Lucca, Italia
- Oncologia AUSL 2 Lucca
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Milano, Italia, 20132
- Irccs Fondazione Centro S. Raffaele Del Monte Tabor
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Napoli, Italia, 80131
- A.O. Universitaria Federico Ii Di Napoli
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Padova, Italia, 35128
- IRCCS Istituto Oncologico Veneto (IOV)
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Pisa, Italia, 56100
- Polo Oncologico Area Vasta Nord Ovest
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Pontedera, Italia, 56100
- Ausl 5 Di Pisa
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Prato, Italia, 59100
- Ospedale Mesericordia E Dolce
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Reggio Emilia, Italia, 42100
- Ospedale S. Maria Nuova
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Roma, Italia
- Campus Biomedico
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Roma, Italia, 00186
- Ospedale San Giovanni Calibita Fatebenefratelli
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Roma, Italia, 00189
- Ospedale San Pietro Fatebenefratelli Di Roma
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Udine, Italia, 33100
- A.O. Universitaria S. Maria Della Misericordia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically proven diagnosis of colorectal cancer.
- Not resectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
- At least one measurable lesion according to RECIST criteria.
- Male or female of 18-75 years of age.
- ECOG PS < 2 if aged < 71 years, ECOG PS = 0 if aged 71-75 years;
- Life expectancy of at least 12 weeks.
- Previous adjuvant chemotherapy containing oxaliplatin is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
- Previous adjuvant chemotherapy with fluoropyrimidine monotherapy is allowed if more than 6 months have elapsed between the end of adjuvant and first relapse;
- Neutrophils 1.5 x 109/L, Platelets 100 x 109/L, Hgb >9 g/dl.
- Total bilirubin 1.5 time the upper-normal limits (UNL) of the institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase 2.5 x UNL, 5 x UNL in case of liver metastases.
- Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL.
- Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <1 g of protein/24 hr.
- Written informed consent to treatment and translational analyses.
Exclusion Criteria:
- Radiotherapy to any site within 4 weeks before the study.
- Previous treatment with bevacizumab
- Untreated brain metastases or spinal cord compression or primary brain tumours.
- History or evidence upon physical examination of CNS disease unless adequately treated.
- Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;
- Serious, non-healing wound, ulcer, or bone fracture.
- Evidence of bleeding diathesis or coagulopathy.
- Uncontrolled hypertension.
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
- Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes.
- Chronic, daily treatment with high-dose aspirin (>325 mg/day).
- Treatment with any investigational drug within 30 days prior to enrollment.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
- Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study (barrier contraceptive measure or oral contraception).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Maintenance:BEVACIZUMAB
Induction: FOLFOXIRI; Manteinance: Bevacizumab
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Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:
with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs): - BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks) |
Experimental: Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE
Induction: FOLFOXIRI; Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE(Metronomic Chemotherapy)
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Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:
with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
progression-free survival (PFS)
Periodo de tiempo: up to 4 years
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PFS is defined as the time from randomization to first documentation of objective disease progression or death due to any cause, whichever occurs first.PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive,on study and progression free at the time of the analysis.Alive patients having no tumor assessments after baseline will have time to event endpoint censored on the date of randomization.Disease status will be evaluated according to RECIST 1.1 criteria.
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up to 4 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Best overall response rate (ORR)
Periodo de tiempo: up to 4 years
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It is defined as the percentage of patients,relative to the total of enrolled subjects,achieving a complete or partial response, according to RECIST 1.1 criteria,during the induction and the maintenance phases of treatment.The determination of clinical response will be based on investigator reported measurements that will be subsequently confirmed by a central review.Responses will be evaluated every 8 weeks.Patients who do not have an on-study assessment will be included in the analysis as non responders.
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up to 4 years
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Duration of response
Periodo de tiempo: up to 4 years
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it is defined as the time from the date when measurement criteria are met for CR or PR until first documentation of objective disease progression
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up to 4 years
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Resection rate
Periodo de tiempo: up to 4 years
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it is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing secondary R0 resection of metastases during treatment or after its completion. Secondary R0 surgery is defined as microscopically margin-free complete surgical removal of all residual disease, allowed by tumoral shrinkage and/or disappearance of one or more lesions. |
up to 4 years
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Time to strategy failure (TSF)
Periodo de tiempo: up to 4 years
|
it is defined as the time from the day of randomization to one of the followings:
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up to 4 years
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Time to 2nd progressive disease
Periodo de tiempo: up to 4 years
|
it is defined as the time from randomization to second documentation of objective disease progression or death due to any cause, whichever occurs first. Time to 2nd progressive disease will be censored on the date of the last evaluable on-study tumor assessment documenting absence of progressive disease for patients who are alive, on study and second progression-free at the time of the analysis. Alive patients having no tumor assessments after baseline will have time to event endpoint censored on the date of randomization. |
up to 4 years
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Overall survival (OS)
Periodo de tiempo: up to 4 years
|
it is defined as the time from randomization to the date of death due to any cause.
For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
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up to 4 years
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Toxicity rate
Periodo de tiempo: up to 4 years
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it is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event, according to National Cancer Institute Common Toxicity Criteria (version 4.0), during the induction and the maintenance phases of treatment.
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up to 4 years
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Overall toxicity rate
Periodo de tiempo: up to 4 years
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it is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 4.0), during the induction and the maintenance phases of treatment.
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up to 4 years
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Cremolini C, Casagrande M, Loupakis F, Aprile G, Bergamo F, Masi G, Moretto R R, Pietrantonio F, Marmorino F, Zucchelli G, Tomasello G, Tonini G, Allegrini G, Granetto C, Ferrari L, Urbani L, Cillo U, Pilati P, Sensi E, Pellegrinelli A, Milione M, Fontanini G, Falcone A. Efficacy of FOLFOXIRI plus bevacizumab in liver-limited metastatic colorectal cancer: A pooled analysis of clinical studies by Gruppo Oncologico del Nord Ovest. Eur J Cancer. 2017 Mar;73:74-84. doi: 10.1016/j.ejca.2016.10.028. Epub 2016 Dec 13.
- Cremolini C, Marmorino F, Bergamo F, Aprile G, Salvatore L, Masi G, Dell'Aquila E, Antoniotti C, Murgioni S, Allegrini G, Borelli B, Gemma D, Casagrande M, Granetto C, Delfanti S, Di Donato S, Schirripa M, Sensi E, Tonini G, Lonardi S, Fontanini G, Boni L, Falcone A. Phase II randomised study of maintenance treatment with bevacizumab or bevacizumab plus metronomic chemotherapy after first-line induction with FOLFOXIRI plus Bevacizumab for metastatic colorectal cancer patients: the MOMA trial. Eur J Cancer. 2019 Mar;109:175-182. doi: 10.1016/j.ejca.2018.12.028. Epub 2019 Feb 5.
- van Dijk E, Biesma HD, Cordes M, Smeets D, Neerincx M, Das S, Eijk PP, Murphy V, Barat A, Bacon O, Prehn JHM, Betge J, Gaiser T, Fender B, Meijer GA, McNamara DA, Klinger R, Koopman M, Ebert MPA, Kay EW, Hennessey BT, Verheul HMW, Gallagher WM, O'Connor DP, Punt CJA, Loupakis F, Lambrechts D, Byrne AT, van Grieken NCT, Ylstra B. Loss of Chromosome 18q11.2-q12.1 Is Predictive for Survival in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab. J Clin Oncol. 2018 Jul 10;36(20):2052-2060. doi: 10.1200/JCO.2017.77.1782. Epub 2018 May 24.
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
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Ciclofosfamida
- Capecitabina
- Bevacizumab
Otros números de identificación del estudio
- MOMA261111
- 2011-006332-23 (Número EudraCT)
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. .
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