- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00081237
OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer
RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine a safe dose for this regimen in these patients.
Secondary
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine the safety profile of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study.
Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A maximum of 12 patients receive treatment at the MTD.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Hannover, Alemania, D-30625
- Medizinische Hochschule Hannover
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England
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Manchester, England, Reino Unido, M20 4BX
- Christie Hospital N.H.S. 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 colorectal cancer
- Radiologic evidence of advanced disease
At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan
- Indicator lesions in a previously irradiated field are allowed provided the irradiated lesion has clearly progressed OR a new lesion has developed in the irradiated field
Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease
- Disease progression during chemotherapy OR within 6 months after completion of treatment
No symptomatic brain metastases meeting any of the following criteria:
- Unstable
- Inadequately controlled with fixed-dose oral steroids
- Potentially life-threatening
- Required radiotherapy with the past 28 days
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin < 1.5 times ULN
- No hepatitis
- No cirrhosis
Renal
- Creatinine < 1.5 times ULN
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- HIV negative
- No preexisting neuropathy ≥ grade 2
- No active or uncontrolled infection
- No other serious illness or medical condition
- No chronic alcohol abuse
- No known hypersensitivity to systemic liposomal formulations or compounds chemically related to OSI-7904L or oxaliplatin
- No prior psychiatric or neurologic condition that would preclude study compliance or giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 21 days since prior immunotherapy
- At least 21 days since prior monoclonal antibody therapy
Chemotherapy
- See Disease Characteristics
- At least 21 days since prior chemotherapy and recovered*
- No prior oxaliplatin NOTE: *Alopecia allowed
Endocrine therapy
- See Disease Characteristics
- At least 21 days since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- At least 21 days since prior radiotherapy and recovered
- No prior radiotherapy to more than 25% of bone marrow reserve
Surgery
- Recovered from prior surgery
Other
- At least 21 days since prior tyrosine kinase inhibitor therapy
- More than 21 days since prior investigational agents
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0
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Medidas de resultado secundarias
Medida de resultado |
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Safety profile as measured by CTC v3.0
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Response as measured by RECIST every 6 weeks (2 courses)
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Pharmacodynamics as measured by drug concentration in the blood during course 1
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Time to progression as measured by Kaplan Meier and RECIST every 6 weeks during treatment and then every 8 weeks
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Colaboradores e Investigadores
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
- 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
- Agentes antineoplásicos
- Oxaliplatino
Otros números de identificación del estudio
- EORTC-16033
- OSI-EORTC-16033
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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