- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00047242
UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
The Pharmacokinetic and Safety Profile of UCN-01 in Combination With Irinotecan in Solid Tumors (Primarily Lung, Ovarian and GI Cancers)
RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced solid tumors.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and irinotecan in patients with advanced solid tumors, primarily lung, ovarian, and gastrointestinal tumors.
- Determine the acute and chronic toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the anti-tumor effect of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the recommended phase II dose.
Patients are followed at 1 month.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 7-15 months.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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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 malignancy that is metastatic or unresectable and for which standard curative or palliative therapy does not exist or is no longer effective
- Gastrointestinal, lung, and ovarian malignancies are given priority
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin normal
- AST/ALT no greater than 2.5 times upper limit of normal (ULN)
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No symptomatic coronary artery disease
- No symptomatic cardiac dysfunction
- No symptoms suggestive of coronary artery disease
- LVEF at least 50%
Pulmonary
- No symptomatic pulmonary dysfunction
- FEV_1 greater than 75% of predicted
- DLCO greater than 75% of predicted
Other
- Amylase no greater than 2 times ULN
- No other concurrent uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No diabetes mellitus or random glucose more than 200 mg/dL
- No prior allergic reaction attributed to compounds of similar biological or chemical composition to UCN-01 or irinotecan (including rash and systemic allergic reaction causing hypotension and respiratory distress)
- No chronic diarrhea (more than 5 stools/day)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 14 days before, during, and for at least 30 days after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior UCN-01 and irinotecan allowed
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No prior mediastinal radiation
Surgery
- Not specified
Other
- At least 14 days since prior warfarin
- No concurrent warfarin unless required for maintaining patency of existing, permanent IV catheters
- No concurrent commercial or other investigational anticancer agents or therapies
- No concurrent combination antiretroviral therapy for HIV-positive patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: Ross C. Donehower, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JHOC-J0173, CDR0000257566
- P30CA006973 (Subvención/contrato del NIH de EE. UU.)
- U01CA070095 (Subvención/contrato del NIH de EE. UU.)
- JHOC-J0173
- NCI-5528
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