此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer

2016年12月12日 更新者：Alliance for Clinical Trials in Oncology

Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-small cell lung cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • Determine the 6-month progression status of older patients with unresectable or metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin and paclitaxel.

Secondary

  • Determine the response rate in patients treated with these regimens.
  • Determine the quality of life of patients treated with these regimens.
  • Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR) concentrations predict response in patients treated with these regimens.
  • Correlate the presence of social support for these patients with toxicity and efficacy of these regimens.
  • Determine whether social support for these patients differs according to gender.
  • Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy regimen for these patients.

Tertiary

  • Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of prespecified germline and tumor genes, and plasma and urine proteomic patterns with response rate and time to progression of patients receiving treatment in group I.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment groups as determined by their treating physician.

  • Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be accrued for this study within 1.7 years.

研究类型

介入性

注册 (实际的)

65

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

  • 加拿大
    • Saskatchewan
      • Regina、Saskatchewan、加拿大、S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85259
        • Mayo Clinic Scottsdale
    • Colorado
      • Fort Collins、Colorado、美国、80524
        • Front Range Cancer Specialists
    • Florida
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Aurora、Illinois、美国、60507
        • Rush-Copley Cancer Care Center
      • Bloomington、Illinois、美国、61701
        • St. Joseph Medical Center
      • Canton、Illinois、美国、61520
        • Graham Hospital
      • Carthage、Illinois、美国、62321
        • Memorial Hospital
      • Effingham、Illinois、美国、62401
        • St. Anthony's Memorial Hospital
      • Eureka、Illinois、美国、61530
        • Eureka Community Hospital
      • Galesburg、Illinois、美国、61401
        • Galesburg Cottage Hospital
      • Galesburg、Illinois、美国、61401
        • Galesburg Clinic
      • Havana、Illinois、美国、62644
        • Mason District Hospital
      • Hopedale、Illinois、美国、61747
        • Hopedale Medical Complex
      • Joliet、Illinois、美国、60435
        • Joliet Oncology Hematology Associates, Limited - West
      • Kewanee、Illinois、美国、61443
        • Kewanee Hospital
      • Macomb、Illinois、美国、61455
        • Mcdonough District Hospital
      • Normal、Illinois、美国、61761
        • Bromenn Regional Medical Center
      • Normal、Illinois、美国、61761
        • Community Cancer Center
      • Ottawa、Illinois、美国、61350
        • Community Hospital of Ottawa
      • Ottawa、Illinois、美国、61350
        • Oncology Hematology Associates of Central Illinois - Ottawa
      • Pekin、Illinois、美国、61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria、Illinois、美国、61636
        • Methodist Medical Center of Illinois
      • Peoria、Illinois、美国、61614
        • Proctor Hospital
      • Peoria、Illinois、美国、61637
        • OSF St. Francis Medical Center
      • Peoria、Illinois、美国、61615
        • CCOP - Illinois Oncology Research Association
      • Peoria、Illinois、美国、61615
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Peru、Illinois、美国、61354
        • Illinois Valley Community Hospital
      • Princeton、Illinois、美国、61356
        • Perry Memorial Hospital
      • Spring Valley、Illinois、美国、61362
        • St. Margaret's Hospital
      • Urbana、Illinois、美国、61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana、Illinois、美国、61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Beech Grove、Indiana、美国、46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Michigan City、Indiana、美国、46360
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Cedar Rapids、Iowa、美国、52402
        • St. Luke's Hospital
      • Cedar Rapids、Iowa、美国、52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids、Iowa、美国、52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • 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、50307
        • Mercy Capitol Hospital
      • Des Moines、Iowa、美国、50316-2301
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Sioux City、Iowa、美国、51101
        • Siouxland Regional Cancer Center
      • Sioux City、Iowa、美国、51104
        • St. Luke's Regional Medical Center
      • Sioux City、Iowa、美国、51104
        • Mercy Medical Center - Sioux City
      • Sioux City、Iowa、美国、51101
        • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
      • West Des Moines、Iowa、美国、50266
        • Medical Oncology and Hematology Associates - West Des Moines
    • Kansas
      • Chanute、Kansas、美国、66720
        • Cancer Center of Kansas, P.A. - Chanute
      • Dodge City、Kansas、美国、67801
        • Cancer Center of Kansas, P.A. - Dodge City
      • El Dorado、Kansas、美国、67042
        • Cancer Center of Kansas, P.A. - El Dorado
      • Kingman、Kansas、美国、67068
        • Cancer Center of Kansas, P.A. - Kingman
      • Liberal、Kansas、美国、67901
        • Southwest Medical Center
      • Newton、Kansas、美国、67114
        • Cancer Center of Kansas, P.A. - Newton
      • Parsons、Kansas、美国、67357
        • Cancer Center of Kansas, P.A. - Parsons
      • Pratt、Kansas、美国、67124
        • Cancer Center of Kansas, P.A. - Pratt
      • Salina、Kansas、美国、67042
        • Cancer Center of Kansas, P.A. - Salina
      • Wellington、Kansas、美国、67152
        • Cancer Center of Kansas, P.A. - Wellington
      • 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、67214
        • Cancer Center of Kansas, P.A. - Wichita
      • Wichita、Kansas、美国、67203
        • Associates in Womens Health, P.A. - North Review
      • Wichita、Kansas、美国、67208
        • Cancer Center of Kansas, P.A. - Medical Arts Tower
      • Winfield、Kansas、美国、67156
        • Cancer Center of Kansas, P.A. - Winfield
    • Michigan
      • Adrian、Michigan、美国、49221
        • Hickman Cancer Center at Bixby Medical Center
      • Lambertville、Michigan、美国、48144
        • Haematology-Oncology Associates of Ohio and Michigan, P.C.
      • Monroe、Michigan、美国、48162
        • Community Cancer Center of Monroe
      • Monroe、Michigan、美国、48162
        • Mercy Memorial Hospital System
    • Minnesota
      • Alexandria、Minnesota、美国、56308
      • Bemidji、Minnesota、美国、56601
        • MeritCare Clinic - Bemidji
      • Brainerd、Minnesota、美国、56401
        • Brainerd Medical Center
      • Brainerd、Minnesota、美国、56401
        • St. Joseph's Medical Center
      • Burnsville、Minnesota、美国、55337
        • Fairview Ridges Hospital
      • Coon Rapids、Minnesota、美国、55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina、Minnesota、美国、55435
        • Fairview Southdale Hospital
      • Fergus Falls、Minnesota、美国、56537
      • Fridley、Minnesota、美国、55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson、Minnesota、美国、55350
        • Hutchinson Area Health Care
      • Lichfield、Minnesota、美国、55355
        • Meeker County Memorial Hospital
      • Maplewood、Minnesota、美国、55109
        • St. John's Hospital
      • Minneapolis、Minnesota、美国、55415
        • Hennepin County Medical Center - Minneapolis
      • Minneapolis、Minnesota、美国、55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Montevideo、Minnesota、美国、56265
        • Chippewa County - Montevideo Hospital
      • Robbinsdale、Minnesota、美国、55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic Cancer Center
      • Saint Cloud、Minnesota、美国、56303
        • Coborn Cancer Center
      • Saint Louis Park、Minnesota、美国、55416
        • CCOP - Metro-Minnesota
      • Shakopee、Minnesota、美国、55379
        • Saint Francis Cancer Center
      • St Paul、Minnesota、美国、55102
        • St. Joseph's Hospital
      • St. Cloud、Minnesota、美国、56303
        • CentraCare Clinic - River Campus
      • St. Louis Park、Minnesota、美国、55416
        • Park Nicollet Health Services
      • St. Paul、Minnesota、美国、55102
        • United Hospital
      • St. Paul、Minnesota、美国、55101
        • Regions Hospital Cancer Care Center
      • Waconia、Minnesota、美国、55387
        • Ridgeview Medical Center
      • Woodbury、Minnesota、美国、55125
        • Woodwinds Health Campus
    • North Dakota
      • Bismarck、North Dakota、美国、58501
        • Bismarck Cancer Center
      • Bismarck、North Dakota、美国、58501
        • Cancer Care Center at Medcenter One Hospital
      • Bismarck、North Dakota、美国、58501
        • Mid Dakota Clinic, P. C.
      • Bismarck、North Dakota、美国、58502
        • St. Alexius Medical Center
      • Fargo、North Dakota、美国、58122
        • CCOP - MeritCare Hospital
      • Fargo、North Dakota、美国、58122
        • MeritCare Medical Group
      • Grand Forks、North Dakota、美国、58201
        • Altru Cancer Center at Altru Hospital
    • Ohio
      • Bowling Green、Ohio、美国、43402
        • Wood County Oncology Center
      • Dayton、Ohio、美国、45428
        • Veterans Affairs Medical Center - Dayton
      • 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、45429
        • CCOP - Dayton
      • Findlay、Ohio、美国、45840
        • Blanchard Valley Medical Associates
      • Fremont、Ohio、美国、43420
        • Fremont Memorial Hospital
      • Kenton、Ohio、美国、43326
        • Kenton Oncology, Incorporated
      • Kettering、Ohio、美国、45429
        • Charles F. Kettering Memorial Hospital
      • Lima、Ohio、美国、45804
        • Lima Memorial Hospital
      • Maumee、Ohio、美国、43537
        • Northwest Ohio Oncology Center
      • Maumee、Ohio、美国、43537
        • St. Luke's Hospital
      • Middletown、Ohio、美国、45044
        • Middletown Regional Hospital
      • Oregon、Ohio、美国、43616
        • St. Charles Mercy Hospital
      • Oregon、Ohio、美国、43616
        • Toledo Clinic - Oregon
      • Sandusky、Ohio、美国、44870
        • Firelands Regional Medical Center
      • Sandusky、Ohio、美国、44870
        • North Coast Cancer Care, Incorporated
      • Sylvania、Ohio、美国、43560
        • Promedica Cancer Center at Flower Hospital
      • 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、43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo、Ohio、美国、43623
        • CCOP - Toledo Community Hospital
      • Toledo、Ohio、美国、43614
        • Medical College of Ohio Cancer Institute
      • Toledo、Ohio、美国、43623
        • Toledo Surgical Specialists
      • 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
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Danville、Pennsylvania、美国、17822-0001
        • Geisinger Medical Center
      • State College、Pennsylvania、美国、16801
        • Geisinger Medical Group
      • Wilkes-Barre、Pennsylvania、美国、18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • South Dakota
      • Sioux Falls、South Dakota、美国、57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls、South Dakota、美国、57105-1080
        • Avera McKennan Hospital and University Health Center
      • Sioux Falls、South Dakota、美国、57105
        • Medical X-Ray Center, P. C.
    • Wisconsin
      • La Crosse、Wisconsin、美国、54601
        • Franciscan Skemp Healthcare

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

65年 至 120年 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Metastatic or unresectable disease

  • Measurable disease

    • At least 1 lesion at least 2.0 cm
    • Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy
  • No meningeal carcinomatosis

  • No untreated brain metastases

    • Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy
  • No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy)

PATIENT CHARACTERISTICS:

Age

  • 65 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • No uncontrolled hepatic disease

Renal

  • Creatinine no greater than 2 times upper limit of normal
  • No uncontrolled renal disease

Cardiovascular

  • No uncontrolled cardiac disease

Pulmonary

  • No clinically active interstitial lung disease

    • Asymptomatic, chronic stable radiographic changes allowed
  • No uncontrolled respiratory disease

Other

  • Fertile patients must use effective contraception
  • Able and willing to complete questionnaires alone or with assistance
  • No known hypersensitivity to gefitinib or any of its excipients
  • No active infection within the past 2 weeks
  • No other prior malignancy within the past 5 years except basal cell skin cancer
  • No grade 2 or greater peripheral neuropathy (CTC v2.0)
  • No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)
  • No dysphagia or inability to swallow intact capsules
  • No significant medical condition that would preclude study treatment or follow-up
  • No severe or uncontrolled systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy for metastatic NSCLC

Endocrine therapy

  • Concurrent steroids allowed provided the dose is not changed

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of marrow-containing skeleton
  • No concurrent radiotherapy (including palliative)

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery
  • No surgery within 7 days after study participation

Other

  • More than 30 days since prior non-FDA approved investigational drugs
  • No concurrent oral retinoids

  • No concurrent CYP3A4-inducing agents, including the following:

    • Carbamazepine
    • Oxcarbazepine
    • Modafinil
    • Ethosuximide
    • Griseofulvin
    • Nafcillin
    • Phenobarbital
    • Phenylbutazone
    • Phenytoin
    • Primidone
    • Rifampin
    • Hypericum perforatum (St. John's wort)
    • Barbiturates
    • Sulfinpyrazone
  • No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)
  • No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration
  • No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin

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：非随机化
  • 介入模型：并行分配
  • 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：gefitinib

Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.
药品：吉非替尼
实验性的：paclitaxel + carboplatin + gefitinib

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.
药品：卡铂
药品：紫杉醇
药品：吉非替尼

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Progression status at 6 months
大体时间：at 6 months
at 6 months

次要结果测量

结果测量
大体时间
无进展生存期
大体时间：长达 5 年
长达 5 年
总生存期
大体时间：长达 5 年
长达 5 年
Confirmed response rate (complete or partial response)
大体时间：Up to 5 years
Up to 5 years
Quality of life as assessed by the Lung Cancer Symptom scale
大体时间：Up to 5 years
Up to 5 years
Social support measure as assessed by the Lubben Social Network scale
大体时间：Up to 5 years
Up to 5 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)

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

2004年10月1日

初级完成 (实际的)

2006年8月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2003年6月5日

首先提交符合 QC 标准的

2003年6月5日

首次发布 (估计)

2003年6月6日

研究记录更新

最后更新发布 (估计)

2016年12月14日

上次提交的符合 QC 标准的更新

2016年12月12日

最后验证

2016年12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-N0222
  • NCI-2012-02535 (注册表标识符：CTRP (Clinical Trials Reporting System))
  • CDR0000304453 (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.

卡铂的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in El Salvador

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅