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Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction

10 de febrero de 2016 actualizado por: Alliance for Clinical Trials in Oncology

A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus

RATIONALE: Monoclonal antibodies, such as panitumumab, 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. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • To determine the pathologic complete response rate in patients with newly diagnosed, locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by surgery.

Secondary

  • To determine the near-complete pathologic response rate in the primary tumor (≤ 10% residual viable cancer).
  • To determine the overall survival and disease-free survival rates of these patients.
  • To determine the safety profile of this regimen.

OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of metastatic disease undergo esophagectomy.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year OR every 6 months for 3 years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

70

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
    • Georgia
      • Savannah, Georgia, Estados Unidos, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Estados Unidos, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Evanston, Illinois, Estados Unidos, 60201-1781
        • Evanston Hospital
      • Springfield, Illinois, Estados Unidos, 62794-9677
        • Simmons Cooper Cancer Institute
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40503-9985
        • Central Baptist Hospital
    • Michigan
      • Royal Oak, Michigan, Estados Unidos, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Winston-Salem, North Carolina, Estados Unidos, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Dayton, Ohio, Estados Unidos, 45406
        • Good Samaritan Hospital
      • Greenville, Ohio, Estados Unidos, 45331
        • Wayne Hospital
      • Kettering, Ohio, Estados Unidos, 45429
        • Charles F. Kettering Memorial Hospital
    • Oregon
      • Portland, Oregon, Estados Unidos, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Estados Unidos, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Pennsylvania
      • Danville, Pennsylvania, Estados Unidos, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • UPMC Cancer Centers
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Hollings Cancer Center at Medical University of South Carolina

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

  1. ≥ 18 years old
  2. ECOG/Zubrod Performance Status 0-1

  3. Biopsy-proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II)

    • Siewert Type I: adenocarcinoma of the distal esophagus
    • Siewert Type II: adenocarcinoma of the esophago-gastric junction/real cardia
  4. Pre-registration EUS, CT of chest and upper abdomen, and PET must support a clinical stage of T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac adenopathy must be ≤ 2 cm by EUS). Clinically staged T1 tumors and T2N0M0 tumors are not eligible. N1 does not require biopsy/FNA. Note: Patients requiring a stent for nutrition must have staging examinations and scans completed before stent placement.
  5. No definitive radiological evidence of distant metastases.
  6. No pre-existing grade 2 or greater peripheral neuropathy (CTCAE v3) of any etiology.

  7. Adequate bone marrow, hepatic and renal function prior to registration:

    • WBC ≥ 3,000/mm³
    • ANC ≥ 1,500/mm³
    • Platelet count ≥ 100,000/mm³
    • Hemoglobin ≥ 9.5 g/dL
    • Creatinine ≤ 1.5 mg/dL
    • Total bilirubin ≤ 3 mg/dL
    • AST (SGOT) ≤ 2.0 times upper limit of normal (ULN)
    • ALT (SGPT) ≤ 2.0 times ULN
    • Alkaline phosphatase ≤ 2.0 times ULN
    • Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL
    • Magnesium ≥ lower limit of normal (LLN)
  8. Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery.
  9. No prior invasive malignancy, unless disease-free for ≥ 5 years prior to registration (Exceptions: non-melanoma skin cancer, in-situ cancers).
  10. Non-pregnant and non-breast feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an an effective method of birth-control while receiving study therapy and for six months after completion of therapy.
  11. No prior chest or upper abdomen radiotherapy; prior therapy with cisplatin, docetaxel, panitumumab or other anti-EGFR therapy or prior esophageal or gastric surgery (Exception: prior surgery to treat reflux disease)
  12. No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psyschiatric illness/social situations that would limit compliance with study requirements.
  13. No history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan
  14. No history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Docetaxel + Cisplatin + Panitumumab + RT
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Droga: docetaxel
Radiación: radioterapia
Procedimiento: cirugía convencional terapéutica
Procedimiento: terapia neoadyuvante
Droga: cisplatino
Biológico: panitumumab

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Pathologic Complete Response Following Surgery
Periodo de tiempo: Post surgery
Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.
Post surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)
Periodo de tiempo: Post surgery
Post surgery
Percentage of Participants With 3-year Overall Survival
Periodo de tiempo: 3 years
Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).
3 years
Percentage of Participants With 2-year Disease-free Survival
Periodo de tiempo: 2 years
Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.
2 years
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Periodo de tiempo: Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery
Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.
Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery

Colaboradores e Investigadores

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

Patrocinador

Alliance for Clinical Trials in Oncology

Colaboradores

National Cancer Institute (NCI)
Amgen

Investigadores

  • Silla de estudio: A. Craig Lockhart, MD, Washington University School of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 enero de 2009

Finalización primaria (Actual)

1 de noviembre de 2011

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

22 de septiembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

22 de septiembre de 2008

Publicado por primera vez (Estimar)

23 de septiembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de marzo de 2016

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

10 de febrero de 2016

Última verificación

1 de febrero de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACOSOG-Z4051
  • U10CA076001 (Subvención/contrato del NIH de EE. UU.)
  • CDR0000596674 (Identificador de registro: Physician Data Query)
  • NCI-2009-00346 (Identificador de registro: NCI Clinical Trials Reporting Office)

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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