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Gemcitabine With or Without Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

10 de diciembre de 2009 actualizado por: University of Medicine and Dentistry of New Jersey

A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared with gemcitabine alone in treating patients with metastatic or unresectable kidney cancer.

Descripción general del estudio

Descripción detallada

OBJECTIVES:

Primary

  • Compare stable disease and objective response in patients with metastatic or unresectable renal cell carcinoma treated with gemcitabine hydrochloride with or without imatinib mesylate.

Secondary

  • Evaluate the median survival, progression-free survival, and response rate in patients treated with gemcitabine hydrochloride and imatinib mesylate.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression in both tumor cells and associated endothelial cells using immunohistochemistry staining of paraffin-embedded tissue.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by histology (clear cell vs nonclear cell) and prior therapy (immunotherapy/chemotherapy vs targeted agents).

Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete response after 2 courses of treatment continue treatment with gemcitabine hydrochloride and imatinib mesylate in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 2 courses of treatment are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.
  • Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12.

In both arms, treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Available archived tumor tissue samples are obtained for immunohistochemical analysis to quantify the expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

100

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New Jersey
      • New Brunswick, New Jersey, Estados Unidos, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma

    • Metastatic disease OR unresectable primary tumor
    • No known curative therapy exists
  • Documented progressive renal cell carcinoma as defined by RECIST criteria within the past 6 months
  • Measurable disease with ≥ 1 unidimensionally measurable lesion
  • No known symptomatic brain metastasis or untreated brain metastases or carcinomatous meningitis

    • Treated brain metastasis allowed provided the following criteria are met:

      • Clinically stable
      • More than 7 days since prior steroids

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment
  • Must be able to swallow oral medication
  • No coexisting medical condition that would preclude study compliance
  • No history of allergic reaction to compounds of similar chemical or biological composition to gemcitabine hydrochloride and/or imatinib mesylate
  • No uncontrolled illness that would preclude study participation
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia requiring therapy
  • No myocardial infarction within the past 6 months
  • No active infection
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No New York Heart Association class III-IV congestive heart failure
  • No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
  • No known HIV positivity
  • No significant history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • No more than 3 prior treatment regimens, including any of the following:

    • No more than 1 prior cytotoxic therapy
    • Immunotherapy regimens comprising interferon and/or aldesleukin
    • Therapy with molecular targets
    • Any combination of the above treatments to a maximum of 3 total therapies
  • No prior gemcitabine hydrochloride for metastatic disease
  • No prior imatinib mesylate for metastatic disease
  • More than 2 weeks since prior major surgery
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 3 weeks since prior anti-vascular endothelial growth factor therapy
  • At least 3 weeks since prior radiotherapy

    • Must have evidence of ≥ 1 measurable target lesion outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy
  • At least 28 days since prior and no other concurrent investigational or commercial agents, unless disease is rapidly progressing
  • No concurrent therapeutic warfarin

    • Concurrent low molecular weight heparin or heparin allowed for therapeutic anticoagulation
    • Concurrent prophylactic warfarin therapy ≤ 1 mg daily to maintain catheter patency allowed
  • No concurrent filgrastim (G-CSF) for prevention of neutropenia
  • No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
  • No concurrent routine use (i.e., daily or every other day) of systemic corticosteroid therapy (in supraphysiologic doses)
  • No concurrent medication that would preclude study compliance

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Respuesta objetiva
Enfermedad estable

Medidas de resultado secundarias

Medida de resultado
Tasa de respuesta
Supervivencia libre de progresión
Supervivencia mediana
Expression of c-KIT and platelet-derived growth factor receptor-alpha protein expression

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Mark Stein, MD, Rutgers Cancer Institute of New Jersey

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2006

Finalización primaria (Actual)

1 de agosto de 2007

Finalización del estudio (Actual)

1 de agosto de 2007

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2006

Primero enviado que cumplió con los criterios de control de calidad

8 de mayo de 2006

Publicado por primera vez (Estimar)

10 de mayo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de diciembre de 2009

Última actualización enviada que cumplió con los criterios de control de calidad

10 de diciembre de 2009

Última verificación

1 de diciembre de 2009

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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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