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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary

16 de febrero de 2017 actualizado por: Alliance for Clinical Trials in Oncology

A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in Previously Untreated Patients With Measurable Disease With Cancer of Unknown Primary (CUP)

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • Evaluate the response rate in patients with previously untreated cancer of unknown primary treated with the combination of carboplatin, paclitaxel, and everolimus.

Secondary

  • Assess time to progression, overall survival, duration of response, and time to treatment failure in patients treated with this regimen.
  • Determine adverse events of this regimen in these patients.
  • Perform descriptive correlative studies to determine response of specific tumor types, identified by the Origin-FFPE test, to this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive oral everolimus once daily on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients' tumor tissue samples from the most recent biopsy are analyzed for correlative studies, including gene expression profiling by Origin-FFPE test.

After completion of study therapy, patients are followed up every 3 months until disease progression, and then every 6 months for up to 3 years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

46

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
    • Colorado
      • Fort Collins, Colorado, Estados Unidos, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Estados Unidos, 80528
        • Front Range Cancer Specialists
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Illinois
      • Moline, Illinois, Estados Unidos, 61265
      • Moline, Illinois, Estados Unidos, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    • Indiana
      • Elkhart, Indiana, Estados Unidos, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Estados Unidos, 46514-2098
        • Elkhart Clinic, LLC
      • Elkhart, Indiana, Estados Unidos, 46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Indianapolis, Indiana, Estados Unidos, 46237
        • St. Francis Hospital Cancer Care Services
      • Kokomo, Indiana, Estados Unidos, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Estados Unidos, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, Estados Unidos, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, Estados Unidos, 46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth, Indiana, Estados Unidos, 46563
        • Michiana Hematology Oncology PC - Plymouth
      • Richmond, Indiana, Estados Unidos, 47374
        • Reid Hospital & Health Care Services
      • South Bend, Indiana, Estados Unidos, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Estados Unidos, 46601
        • CCOP - Northern Indiana CR Consortium
      • Westville, Indiana, Estados Unidos, 46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Ames, Iowa, Estados Unidos, 50010
        • McFarland Clinic, PC
      • Bettendorf, Iowa, Estados Unidos, 52722
      • Cedar Rapids, Iowa, Estados Unidos, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Estados Unidos, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Clive, Iowa, Estados Unidos, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Des Moines, Iowa, Estados Unidos, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Estados Unidos, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Estados Unidos, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Estados Unidos, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Estados Unidos, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Estados Unidos, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Ottumwa, Iowa, Estados Unidos, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, Estados Unidos, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Estados Unidos, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Estados Unidos, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, Estados Unidos, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Estados Unidos, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Estados Unidos, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Estados Unidos, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Estados Unidos, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Estados Unidos, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Estados Unidos, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Estados Unidos, 67901
        • Cancer Center of Kansas, PA - Liberal
      • Newton, Kansas, Estados Unidos, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Estados Unidos, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Estados Unidos, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Estados Unidos, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Estados Unidos, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Estados Unidos, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Estados Unidos, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Estados Unidos, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Estados Unidos, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Estados Unidos, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Estados Unidos, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Adrian, Michigan, Estados Unidos, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Estados Unidos, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Battle Creek Health System Cancer Care Center
      • Dearborn, Michigan, Estados Unidos, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, Estados Unidos, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Estados Unidos, 48503
        • Hurley Medical Center
      • Flint, Michigan, Estados Unidos, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, Estados Unidos, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Estados Unidos, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, Estados Unidos, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, Estados Unidos, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Estados Unidos, 48154
        • St. Mary Mercy Hospital
      • Monroe, Michigan, Estados Unidos, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, Estados Unidos, 48162
        • Mercy Memorial Hospital - Monroe
      • Muskegon, Michigan, Estados Unidos, 49444
        • Mercy General Health Partners
      • Pontiac, Michigan, Estados Unidos, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Estados Unidos, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Reed City, Michigan, Estados Unidos, 49677
        • Spectrum Health Reed City Hospital
      • Saginaw, Michigan, Estados Unidos, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Traverse City, Michigan, Estados Unidos, 49684
        • Munson Medical Center
      • Warren, Michigan, Estados Unidos, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Bemidji, Minnesota, Estados Unidos, 56601
        • MeritCare Bemidji
      • Duluth, Minnesota, Estados Unidos, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Estados Unidos, 55805
        • Miller - Dwan Medical Center
      • Duluth, Minnesota, Estados Unidos, 55805-1983
        • Essentia Health - Duluth Clinic
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Springfield, Missouri, Estados Unidos, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Estados Unidos, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • Springfield, Missouri, Estados Unidos, 65804
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Estados Unidos, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Estados Unidos, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, Estados Unidos, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, Estados Unidos, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Estados Unidos, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Estados Unidos, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Helena, Montana, Estados Unidos, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Estados Unidos, 59901
        • Kalispell Regional Medical Center
      • Missoula, Montana, Estados Unidos, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Estados Unidos, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, Estados Unidos, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, Estados Unidos, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, Estados Unidos, 58102
        • MeritCare Broadway
    • Ohio
      • Bowling Green, Ohio, Estados Unidos, 43402
        • Wood County Oncology Center
      • Dayton, Ohio, Estados Unidos, 45405
        • Grandview Hospital
      • Dayton, Ohio, Estados Unidos, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Estados Unidos, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Estados Unidos, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Estados Unidos, 45420
        • CCOP - Dayton
      • Elyria, Ohio, Estados Unidos, 44035
        • Community Cancer Center
      • Elyria, Ohio, Estados Unidos, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, Estados Unidos, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Estados Unidos, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, Estados Unidos, 45331
        • Wayne Hospital
      • Kettering, Ohio, Estados Unidos, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, Estados Unidos, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Estados Unidos, 43537-1839
        • Northwest Ohio Oncology Center
      • Oregon, Ohio, Estados Unidos, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, Estados Unidos, 43616
        • Toledo Clinic - Oregon
      • Sylvania, Ohio, Estados Unidos, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, Estados Unidos, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Estados Unidos, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Estados Unidos, 43606
        • Toledo Hospital
      • Toledo, Ohio, Estados Unidos, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Estados Unidos, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Estados Unidos, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Estados Unidos, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, Estados Unidos, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Estados Unidos, 43567
        • Fulton County Health Center
      • Xenia, Ohio, Estados Unidos, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Virginia
      • Fredericksburg, Virginia, Estados Unidos, 22401
        • Fredericksburg Oncology, Incorporated
    • Wisconsin
      • Green Bay, Wisconsin, Estados Unidos, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Estados Unidos, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Manitowoc, Wisconsin, Estados Unidos, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, Estados Unidos, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, Estados Unidos, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sheboygan, Wisconsin, Estados Unidos, 53081
        • St. Nicholas Hospital
      • Sturgeon Bay, Wisconsin, Estados Unidos, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay

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

  • Histological confirmation of metastatic adenocarcinoma, poorly differentiated non-small cell carcinoma, or poorly differentiated squamous carcinoma
  • Adequate FFPE tissue or re-biopsy planned after registration but prior to treatment
  • Measurable disease as defined; for patients having only lesions measuring at least 1 cm to =< 2 cm must use spiral computed tomography (CT) imaging for both pre- and post-treatment tumor assessments; disease that has received prior radiation (performed for palliative reasons) cannot be used for measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Hemoglobin (Hgb) >= 9.0 g/dL
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • Platelet count >= 100,000/uL
  • Total bilirubin =< upper limits of normal (ULN); if liver metastases are present, total bilirubin =< 2 x ULN
  • Aspartate aminotransferase (AST) =< 2.5 x ULN; if liver metastases are present, AST =< 5 x ULN
  • Creatinine =< 1.25 x ULN; if > 1.25 x ULN calculated creatinine clearance must be >= 60 ml/min
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Provide informed written consent
  • Willingness to return to NCCTG enrolling institution for follow-up
  • Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study

Exclusion Criteria

  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception; note: adequate contraception must be used throughout the trial and for 8 weeks after the last dose of RAD001, by both sexes
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

  • History of any of the following:

    • Known to be human immunodeficiency virus (HIV) positive
    • Known prior/current history of hepatitis related to hepatitis B or hepatitis C

  • Uncontrolled intercurrent illness including, but not limited to the following:

    • Ongoing or active infection (acute or chronic)
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Severely impaired lung function
    • Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN (note: optimal glycemic control should be achieved before starting trial therapy)
    • Liver disease such as cirrhosis or severe hepatic impairment
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 4 weeks prior to registration
  • Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • Untreated brain metastases; NOTE: patients with treated, stable brain metastases for at least 12 weeks prior to study entry are eligible for enrollment
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Active, bleeding diathesis
  • Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
  • Currently on enzyme inducing anti-convulsants (EIACs) or other strong inducers or strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
  • Current use of warfarin (Coumadin); EXCEPTION: current use of low-molecular weight heparin is allowed
  • Known to be HIV positive
  • Inoculated with live attenuated vaccines =< 2 weeks prior to registration; note: close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guerin (BCG), yellow fever, varicella and TY21a typhoid vaccines
  • =< 4 weeks from major surgery; note: for this study, diagnostic laparoscopy (without other intervention) and/or biopsies (needle aspirate, core biopsy, open biopsy, etc.) are not considered major surgery

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
Experimental: Treatment (carboplatin, paclitaxel, and everolimus)
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Droga: paclitaxel
Dado IV
Droga: carboplatino
Dado IV
Droga: everolimus
Orden de compra dada

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Confirmed Tumor Responses
Periodo de tiempo: First 6 Cycles of treatment (an average of 6 months)

Confirmed tumor response was defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

  • Complete Response (CR): disappearance of all target lesions;
  • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
First 6 Cycles of treatment (an average of 6 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: Time from registration to death or last follow-up (up to 3 years)
Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.
Time from registration to death or last follow-up (up to 3 years)
Progression-free Survival
Periodo de tiempo: Time from registration to the disease progression or death (up to 3 years)
The progression-free survival (PFS) was defined as the time from date of registration to the documentation of disease progression or death as a result of any cause, whichever comes first.
Time from registration to the disease progression or death (up to 3 years)
Duration of Response
Periodo de tiempo: Up to 3 years
Duration of response was defined for all evaluable participants who have achieved an objective response as the date at which the participant's objective status is first noted to be either CR or PR to the date progression is documented.
Up to 3 years
Time to Treatment Failure
Periodo de tiempo: Up to 3 years
Time to treatment failure was defined to be the time from the date of registration to the date at which the participant is removed from treatment due to progression, adverse events, or refusal.
Up to 3 years

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)

Investigadores

  • Silla de estudio: Matthew P. Goetz, MD, Mayo Clinic

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 septiembre de 2009

Finalización primaria (Actual)

1 de diciembre de 2012

Finalización del estudio (Actual)

1 de agosto de 2013

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2009

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2009

Publicado por primera vez (Estimar)

10 de julio de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de marzo de 2017

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

16 de febrero de 2017

Última verificación

1 de febrero de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCCTG-N0871
  • NCI-2011-01926 (Identificador de registro: CTRP (Clinical Trials Reporting System))
  • CDR0000643361 (Identificador de registro: PDQ (Physician Data Query))

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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