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Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery

6 de mayo de 2014 actualizado por: National Cancer Institute (NCI)

An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma

This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVES:

I. To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine, before and after capecitabine plus radiation and during capecitabine plus radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting.

II. To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in patients with resected pancreatic cancer.

III. To obtain tissue specimens from resections of patients enrolled on study for correlative studies and further evaluations.

SECONDARY OBJECTIVES:

I. To evaluate disease-free and overall survival for patients receiving either cetuximab or bevacizumab in combination with gemcitabine before and after capecitabine plus radiation.

II. To assess the safety profile for patients receiving either capecitabine plus cetuximab plus radiation, or capecitabine plus bevacizumab plus radiation.

III. To correlate changes in serum amphiregulin and TGF alpha to survival, DFS and rash for patients receiving cetuximab.

IV. To determine the 2-year survival rate for patients receiving either cetuximab plus gemcitabine before and after capecitabine plus cetuximab plus radiation, or bevacizumab plus gemcitabine before and after capecitabine plus bevacizumab plus radiation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).

Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

137

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

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Eastern Cooperative Oncology Group

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

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma
  • Patients must have had all gross disease resected (R0 or R1 resection)
  • Patients undergoing an R2 resection are not eligible
  • Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer and must have had no prior EGFR/VEGF inhibition
  • Patient must have ECOG performance status of 0-2
  • Leukocytes >= 3,000/μL
  • ANC >= 1,500/μL
  • Platelets >= 100,000/μL
  • Total bilirubin Within normal institutional limits
  • AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
  • Creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
  • Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration (may be up to 10 weeks post-surgery prior to start of study therapy)
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception prior to study entry
  • Women must not be pregnant or breast-feeding; all agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
  • Patients must not be receiving any other investigational agents
  • Patients with known metastases are not eligible
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab or other agents used in the study are not eligible
  • Patients with wounds that have not fully healed are not eligible
  • Patients must not have cardiac arrhythmia
  • Patients must have no known HIV infection
  • Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma
  • Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
  • Patients requiring full dose anticoagulation are not eligible
  • Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible

  • Patients with a history of the following within twelve months of study entry are not eligible:

    • Arterial thrombembolic events
    • Unstable angina
    • Myocardial infarction

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
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm I (cetuximab, gemcitabine, capecitabine, radiation)
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
Otro: análisis de biomarcadores de laboratorio
Estudios correlativos
Droga: clorhidrato de gemcitabina
Dado IV
Otros nombres:
  • Gemzar
  • gemcitabina
  • dfdc
  • clorhidrato de difluorodesoxicitidina
Biológico: cetuximab
Dado IV
Otros nombres:
  • C225
  • IMC-C225
  • Anticuerpo monoclonal C225
  • MOAB C225
  • anticuerpo monoclonal C225
Droga: capecitabina
Administrado oralmente
Otros nombres:
  • Xeloda
  • CAPA
  • Ro 09-1978/000
Radiación: radioterapia
Someterse a radioterapia
Otros nombres:
  • irradiación
  • radioterapia
  • terapia, radiación
Experimental: Arm II (bevacizumab, gemcitabine, capecitabine, radiation)
Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
Otro: análisis de biomarcadores de laboratorio
Estudios correlativos
Biológico: bevacizumab
Dado IV
Otros nombres:
  • Avastin
  • anticuerpo monoclonal humanizado anti-VEGF
  • anticuerpo monoclonal anti-VEGF
  • rhuMAb VEGF
Droga: clorhidrato de gemcitabina
Dado IV
Otros nombres:
  • Gemzar
  • gemcitabina
  • dfdc
  • clorhidrato de difluorodesoxicitidina
Droga: capecitabina
Administrado oralmente
Otros nombres:
  • Xeloda
  • CAPA
  • Ro 09-1978/000
Radiación: radioterapia
Someterse a radioterapia
Otros nombres:
  • irradiación
  • radioterapia
  • terapia, radiación

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy
Periodo de tiempo: Every 2 weeks while on treatment and for 30 days after the end of treatment

Specific toxicities to be monitored pursuant to the primary endpoint include:

  1. Any grade 5 toxicities
  2. Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension
  3. Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis
  4. ECOG performance status decline by 2 or greater for >24 hours
  5. Weight loss >10%
Every 2 weeks while on treatment and for 30 days after the end of treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Two-year Overall Survival Rate
Periodo de tiempo: Assessed every 3 months for 2 years
Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.
Assessed every 3 months for 2 years
Two-year Disease-free Survival (DFS)
Periodo de tiempo: Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years
Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).
Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years

Colaboradores e Investigadores

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

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Jordan Berlin, Eastern Cooperative Oncology Group

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 febrero de 2006

Finalización primaria (Actual)

1 de julio de 2008

Finalización del estudio (Actual)

1 de febrero de 2012

Fechas de registro del estudio

Enviado por primera vez

21 de marzo de 2006

Primero enviado que cumplió con los criterios de control de calidad

21 de marzo de 2006

Publicado por primera vez (Estimar)

22 de marzo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de mayo de 2014

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

6 de mayo de 2014

Última verificación

1 de diciembre de 2012

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCI-2012-02969 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • U10CA021115 (Subvención/contrato del NIH de EE. UU.)
  • CALGB-ECOG-E2204
  • SWOG-ECOG-E2204
  • ECOG-E2204
  • NCCTG-ECOG-E2204
  • E2204 (Otro identificador: CTEP)

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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