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

16 febbraio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

46

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Dato IV
Droga: carboplatino
Dato IV
Droga: everolimus
Dato PO

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Confirmed Tumor Responses
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Matthew P. Goetz, MD, Mayo Clinic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2009

Completamento primario (Effettivo)

1 dicembre 2012

Completamento dello studio (Effettivo)

1 agosto 2013

Date di iscrizione allo studio

Primo inviato

8 luglio 2009

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2009

Primo Inserito (Stima)

10 luglio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 febbraio 2017

Ultimo verificato

1 febbraio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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