- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00062127
Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced Solid Tumors
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors.
II. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients.
III. Determine the toxicity of this regimen in these patients. IV. Determine the observed antitumor response in patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28.
Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7.
All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Comprehensive Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Histologically confirmed malignant solid tumor
- Metastatic or unresectable
- Standard curative or palliative therapy is no longer effective or does not exist
- Measurable or assessable disease
No uncontrolled brain metastases
Patients with brain metastases are eligible provided the following are true:
- Stable neurologic status
- At least 4 weeks since prior steroids or anticonvulsants
- No neurologic dysfunction that would confound evaluation
- Performance status - Karnofsky 70-100%
- More than 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of inflammatory bowel disease requiring therapy
- No chronic diarrhea syndromes
- No paralytic ileus
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use 2 forms of effective contraception, including 1 highly effective method, for at least 4 weeks before, during, and for 4 weeks after study participation
- Male patients must use effective barrier contraception during and for 4 weeks after study participation
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
- No uncontrolled seizure disorder
- No other concurrent uncontrolled illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No ongoing or active infection
- No significant traumatic injury within the past 28 days
- No serious, nonhealing wounds or ulcers
- No bone fractures
- No preexisting peripheral neuropathy grade 2 or greater
- At least 4 weeks since prior biologic therapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- More than 28 days since prior major surgical procedure or open biopsy
- At least 4 weeks since prior investigational therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational or commercial agents or therapies for the malignancy
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 |
---|---|
Experimental: Arm I (irinotecan hydrochloride and thalidomide)
Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28.
All patients undergo disease re-evaluation at 6 weeks.
Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Estudios correlativos
Otros nombres:
Dado IV
Otros nombres:
Administrado oralmente
Otros nombres:
|
Experimental: Arm II (irinotecan hydrochloride and thalidomide)
Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks.
Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Estudios correlativos
Otros nombres:
Dado IV
Otros nombres:
Administrado oralmente
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Effect of thalidomide on irinotecan hydrochloride pharmacokinetics
Periodo de tiempo: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours
|
Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours
|
|
Effect of irinotecan hydrochloride on thalidomide pharmacokinetics
Periodo de tiempo: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 and 168 hours
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 and 168 hours
|
|
Grade 3 or greater toxicities assessed using NCI CTC version 2.0
Periodo de tiempo: Up to 3 years
|
Will be summarized and analyzed using descriptive statistics.
Exact 90% confidence intervals using the binomial distribution will be derived.
|
Up to 3 years
|
Response assessed using RECIST criteria
Periodo de tiempo: Up to 3 years
|
Will be summarized and analyzed using descriptive statistics.
Exact 90% confidence intervals using the binomial distribution will be derived.
|
Up to 3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark Ratain, University of Chicago Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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 (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
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Inhibidores de la topoisomerasa
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Agentes antibacterianos
- Agentes leprostáticos
- Inhibidores de la topoisomerasa I
- Talidomida
- Irinotecán
Otros números de identificación del estudio
- NCI-2012-02537
- U01CA069852 (Subvención/contrato del NIH de EE. UU.)
- 12044B
- CDR0000304517 (Identificador de registro: PDQ (Physician Data Query))
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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