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

2017年2月16日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

46

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：紫杉醇
鉴于IV
药品：卡铂
鉴于IV
药品：依维莫司
给定采购订单

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With Confirmed Tumor Responses
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Overall Survival
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Matthew P. Goetz, MD、Mayo Clinic

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年9月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2009年7月8日

首先提交符合 QC 标准的

2009年7月8日

首次发布 (估计)

2009年7月10日

研究记录更新

最后更新发布 (实际的)

2017年3月21日

上次提交的符合 QC 标准的更新

2017年2月16日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NCCTG-N0871
  • NCI-2011-01926 (注册表标识符：CTRP (Clinical Trials Reporting System))
  • CDR0000643361 (注册表标识符：PDQ (Physician Data Query))

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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