- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00731276
Irinotecan in Treating Asian Patients With Solid Tumors
Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors.
Secondary
- To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites SN-38 and SN-38G.
- To evaluate time to tumor response, response duration, and time to progression in these patients.
OUTLINE: Patients are stratified according to genotype status (UGT1A1*28 vs UGT1A1*6)
Patients receive irinotecan hydrochloride IV once weekly for 3 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic, and pharmacodynamic studies.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Singapore, Singapur, 169610
- National Cancer Centre - Singapore
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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 or cytologically confirmed solid tumors
- Failed at least one line of prior chemotherapy
- Must belong to either Chinese, Malay, or Indian ethnic groups
- Previously irradiated disease allowed provided marker lesions not within the irradiated field
Presence of at least one bidimensionally measurable, non-CNS indicator lesion, defined by radiologic study (including CT or MRI scan, ultrasound, or chest X-ray) or physical exam, meeting 1 of the following criteria:
- Measurable disease on CT or MRI scan must have one diameter ≥ 1 cm and one diameter ≥ 2 cm
- Measurable disease on chest X-ray or ultrasound must have both diameters ≥ 2 cm
- Palpable tumor masses that cannot be evaluated radiologically must have two diameters ≥ 2 cm
- Measurable skin lesion must have at least one diameter ≥ 1 cm
- No unidimensionally measurable or evaluable only disease
- No known brain or leptomeningeal metastasis
- No uncontrolled large pleural effusions
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute granulocyte count ≥ 1,000/µL
- WBC ≥ 3,500/µL
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/µL
- Serum total bilirubin ≤ 2.0 mg/dL
- ALT/AST < 2.5 times normal (5 times normal in patients with known metastatic disease in the liver)
- Creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical problems severe enough to prevent compliance with the study requirements
- No prior malignancies, except for adequately treated basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 5 years
- No active or uncontrolled infection
- No pre-existing cardiac disease, including congestive heart failure, arrhythmia requiring treatment, or myocardial infarction within the past 3 months
- No pneumonitis
- No uncontrolled diabetes mellitus (i.e., random blood glucose > 200 mg/dL)
- No inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
- At least 1 week since prior and no concurrent ketoconazole
- More than 4 weeks since prior chemotherapy or radiotherapy
- At least 2 weeks since prior and no concurrent Hypericum perforatum (St. John wort)
- No prior irinotecan hydrochloride
- No concurrent investigational antineoplastic therapy or other investigational drugs
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Four Regimens
The study has four type of regimens, and dosing of irinotecan depends on genotype of patient. Four Regimens are:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Dose-limiting toxicity
Periodo de tiempo: No time frame defined. Trial is still recruiting.
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No time frame defined. Trial is still recruiting.
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Maximum tolerated dose
Periodo de tiempo: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Pharmacokinetics
Periodo de tiempo: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
|
Time to tumor response
Periodo de tiempo: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
|
Time to progression
Periodo de tiempo: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
|
Response duration
Periodo de tiempo: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Su Pin Choo, MD, National Cancer Centre, Singapore
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- CDR0000601207
- SINGAPORE-NCC0703
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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