- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00949455
A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium (LaMB)
A Phase II/III, Randomised, Two-Arm, Comparison of Maintenance Lapatinib Versus Placebo After First-Line Chemotherapy in Patients With HER1 and/or HER2 Overexpressing Locally Advanced or Metastatic Bladder Cancer [LaMB]
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether lapatinib ditosylate is more effective than a placebo in killing tumor cells.
PURPOSE: This randomized phase II/III trial is studying how well lapatinib ditosylate works compared to a placebo in treating patients with stage IV bladder cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.
Secondary
- Compare overall survival between these patient groups.
- Evaluate the safety and tolerability of the regimens in these patients.
- Assess and compare quality of life between these patient groups.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status and response to first line chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity.
Patients undergo quality of life assessment by EORTC QLQ-C30 at baseline and every 4 weeks during study treatment.
After completion of study treatment, patients are followed up periodically for up to 5 years.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Aberdeen, Reino Unido
- NHS Grampian - Aberdeen Royal Infirmary
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Basildon, Reino Unido
- Basildon and Thurrock University Hospital NHS Trust - Basildon Hospital
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Birmingham, Reino Unido
- University Hospitals Birmingham NHS Foundation Trust - Birmingham University Hospital
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Bournemouth, Reino Unido
- Royal Bournemouth and Christchurch NHS Foundation Trust - Royal Bournemouth Hospital
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Bristol, Reino Unido
- University Hospitals Bristol NHS Trust - Bristol University Hospital
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Cambridge, Reino Unido
- Cambridge University Hospitals NHS Trust - Addenbrooke's Hospital
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Chelmsford, Reino Unido
- Mid Essex NHS Trust - Broomfield Hospital
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Colchester, Reino Unido
- Colchester University Hospitals NHS Trust
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Coventry, Reino Unido
- University Hospitals Coventry & Warwickshire NHS Trust
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Derby, Reino Unido
- Derby Hospitals NHS Trust - Royal Derby Hospital
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Glasgow, Reino Unido
- NHS Greater Glasgow and Clyde - The Beatson
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Huddersfield, Reino Unido
- Calderdale and Huddersfield NHS Trust - Huddersfield Royal Infirmary
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Ipswich, Reino Unido
- Ipswich Hospital NHS Trust
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Leicester, Reino Unido
- University Hospitals of Leicester NHS Trust
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Liverpool, Reino Unido
- Clatterbridge Centre for Oncology NHS Trust
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London, Reino Unido
- Imperial Healthcare NHS Trust
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London, Reino Unido
- Guys & St Thomas' Hospital NHS Trust - Guys Hospital
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London, Reino Unido
- Royal Marsden NHS Trust
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Middlesborough, Reino Unido
- South Tees NHS Trust - James Cook University Hospital
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Newcastle, Reino Unido
- Newcastle Upon Tyne Hospitals NHS Trust
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Northampton, Reino Unido
- Northampton General Hospitals NHS Trust
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Nottingham, Reino Unido
- Nottingham University Hospitals NHS Trust
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Nottingham, Reino Unido
- Sherwood Forest Hospitals NHS Trust - Kings Mill Hospital
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Portsmouth, Reino Unido
- Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
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Romford, Reino Unido
- Barking, Havering and Redbridge NHS Trust - Queens Hospital
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Taunton, Reino Unido
- Taunton and Somerset NHS Trust - Musgrove Park Hospital
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England
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London, England, Reino Unido, EC1M 6BQ
- Barts and The London NHS Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the bladder
- Stage IV disease
- Metastatic or locally advanced disease
HER1- and/or HER2-positive disease, defined by the following criteria:
- 2+ or 3+ intensity on IHC
- Able to commence the study treatment within 10 weeks of completing chemotherapy
Must have achieved objective response or stable disease following 4-8 courses of first-line chemotherapy
- No progression with first-line chemotherapy for metastatic disease
- Any widely accepted chemotherapy regimen for bladder cancer allowed
- Patients who did not receive cisplatin are eligible
PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- ANC ≥ 1.0 x 10^9/L
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 75 x 10^9/L
- ALT/AST < 2 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- Serum creatinine ≤ 3.0 ULN AND/OR creatinine clearance ≥ 30 mL/min
- LVEF ≥ 50% (as assessed by quantitative echocardiogram or MUGA)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No current active hepatic or biliary disease, except for any of the following:
- Gilbert's syndrome
- Asymptomatic gallstones
- Liver metastases
- Stable chronic liver disease per investigator assessment
- No known hypersensitivity to the study medication
No history of prior or concurrent other neoplasms, except for:
- Any non life-threatening tumours that have been curatively treated.
- Prostate cancer isolated to the prostate gland
No significant cardiac disease, including any of the following:
- Angina pectoris
- Severe cardiac arrhythmia requiring medication
- Severe conduction abnormalities
- Clinically significant valvular disease
- Cardiomegaly
- Prior myocardial infarction
- Ventricular hypertrophy
- Congestive heart failure
- Poorly uncontrolled hypertension (resting diastolic blood pressure > 115 mm Hg)
- Other cardiomyopathy
- No serious intercurrent medical or psychiatric illness
- No serious active infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant/adjuvant chemotherapy allowed)
- No more than 10 weeks since first-line chemotherapy
- No prior lapatinib ditosylate
- No prior radiotherapy to the indicator lesion(s) (newly arising lesions in previously irradiated areas allowed)
At least 14 days since prior and no concurrent CYP3A4 inducers, including but not limited to, any of the following:
- Antibiotics (all rifamycin class agents [e.g., rifampicin, rifabutin, rifapentine])
- Anticonvulsants (phenytoin, carbamazepine, barbiturates [e.g., phenobarbital])
- Oral glucocorticoids (cortisone [> 50 mg], hydrocortisone [> 40 mg], prednisone [> 10 mg], methylprednisolone [> 8 mg], dexamethasone [> 2 mg²])
- St. John's wort or modafinil
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including but not limited to, any of the following:
- Antibiotics (clarithromycin, erythromycin, troleandomycin)
- Antifungals (itraconazole, ketoconazole, fluconazole [>150 mg daily], voriconazole)
- Antiretrovirals/protease inhibitors (delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir)
- Calcium channel blockers (verapamil, diltiazem)
- Antidepressants (nefazodone, fluvoxamine)
- Gastrointestinal agents (cimetidine, aprepitant)
- Grapefruit, grapefruit juice
- At least 6 months since prior and no concurrent amiodarone
- No concurrent radical or curative therapy (radiotherapy or surgery) at the end of first-line treatment (palliative radiotherapy allowed)
- No other concurrent experimental or investigational drugs
- No other concurrent anticancer treatment, including cytotoxic or specific immune therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm I
Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.
|
Administrado oralmente
Otros nombres:
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Comparador de placebos: Arm II
Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity.
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Administrado oralmente
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Progression free survival
Periodo de tiempo: Disease Progression - at least 20% increase in the sum of longest diameters of target lesions.
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Disease Progression - at least 20% increase in the sum of longest diameters of target lesions.
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Medidas de resultado secundarias
Medida de resultado |
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Sobrevivencia promedio
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas Powles, MD, MRCP, Queen Mary University of London
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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 (Estimar)
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
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades urológicas
- Enfermedades de la vejiga urinaria
- Neoplasias de la vejiga urinaria
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Lapatinib
Otros números de identificación del estudio
- CDR0000640393
- OCTG-LaMB
- BL-2007-02
- EUDRACT-2007-001826-28
- EU-20929
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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