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Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

2017년 2월 16일 업데이트: Alliance for Clinical Trials in Oncology

A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD2171 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. Giving gemcitabine and carboplatin together with AZD2171 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin without AZD2171 as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:

Primary

  • Assess the objective tumor response rate in patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride, carboplatin, and AZD2171 as first-line therapy.

Secondary

  • Compare the proportion of patients who are progression-free at 6 months after treatment with gemcitabine hydrochloride and carboplatin with vs without AZD2171.
  • Compare the duration of response for responding patients treated with these regimens.
  • Compare the time-to-progression and time-to-treatment failure.
  • Compare the 1-year overall survival.
  • Compare the clinical toxicities.
  • Assess the safety and tolerability of these regimens in these patients.

Tertiary

  • Collect blood and tumor specimens for future evaluation of pharmacogenetic and proteomic markers of tumor response and toxicity to therapy with these agents.
  • Bank paraffin-embedded tissue blocks/slides and blood samples for future histochemistry evaluation and DNA extraction.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for pharmacologic correlative studies.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.

연구 유형

중재적

등록 (실제)

101

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85259-5499
        • Mayo Clinic Scottsdale
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Aurora, Illinois, 미국, 60504
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, 미국, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, 미국, 61520
        • Graham Hospital
      • Carthage, Illinois, 미국, 62321
        • Memorial Hospital
      • Eureka, Illinois, 미국, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, 미국, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, 미국, 61401
        • Galesburg Clinic, PC
      • Havana, Illinois, 미국, 62644
        • Mason District Hospital
      • Hopedale, Illinois, 미국, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, 미국, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Macomb, Illinois, 미국, 61455
        • Mcdonough District Hospital
      • Moline, Illinois, 미국, 61265
      • Moline, Illinois, 미국, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
      • Normal, Illinois, 미국, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, 미국, 61761
        • Community Cancer Center
      • Ottawa, Illinois, 미국, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, 미국, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, 미국, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, 미국, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, 미국, 61614
        • Proctor Hospital
      • Peoria, Illinois, 미국, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, 미국, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, 미국, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, 미국, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, 미국, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, 미국, 61362
        • St. Margaret's Hospital
      • Urbana, Illinois, 미국, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, 미국, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, 미국, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, 미국, 46904
        • Howard Community Hospital
      • La Porte, Indiana, 미국, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, 미국, 46360
        • Saint Anthony Memorial Health Centers
      • South Bend, Indiana, 미국, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, 미국, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, 미국, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, 미국, 46617
        • South Bend Clinic
    • Iowa
      • Bettendorf, Iowa, 미국, 52722
      • Cedar Rapids, Iowa, 미국, 52403
        • Cedar Rapids Oncology Associates
      • Des Moines, Iowa, 미국, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, 미국, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, 미국, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, 미국, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, 미국, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, 미국, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Des Moines, Iowa, 미국, 50307
        • Mercy Capitol Hospital
      • Mason City, Iowa, 미국, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Sioux City, Iowa, 미국, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, 미국, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, 미국, 51104
        • Mercy Medical Center - Sioux City
    • Michigan
      • Ann Arbor, Michigan, 미국, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, 미국, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, 미국, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, 미국, 49307
        • Mecosta County Medical Center
      • Dearborn, Michigan, 미국, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, 미국, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, 미국, 48503
        • Hurley Medical Center
      • Flint, Michigan, 미국, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, 미국, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, 미국, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, 미국, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, 미국, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Holland, Michigan, 미국, 49423
        • Holland Community Hospital
      • Iron Mountain, Michigan, 미국, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, 미국, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, 미국, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, 미국, 48154
        • St. Mary Mercy Hospital
      • Muskegon, Michigan, 미국, 49442
        • Hackley Hospital
      • Pontiac, Michigan, 미국, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, 미국, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, 미국, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • St. Joseph, Michigan, 미국, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Traverse City, Michigan, 미국, 49684
        • Munson Medical Center
      • Warren, Michigan, 미국, 48093
        • St. John Macomb Hospital
      • Wyoming, Michigan, 미국, 49519
        • Metro Health Hospital
    • Minnesota
      • Bemidji, Minnesota, 미국, 56601
        • MeritCare Bemidji
      • Burnsville, Minnesota, 미국, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, 미국, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, 미국, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, 미국, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, 미국, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, 미국, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, 미국, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, 미국, 55350
        • Hutchinson Area Health Care
      • Lichfield, Minnesota, 미국, 55355
        • Meeker County Memorial Hospital
      • Mankato, Minnesota, 미국, 56002
        • Immanuel St. Joseph's
      • Maplewood, Minnesota, 미국, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, 미국, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, 미국, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, 미국, 55415
        • Hennepin County Medical Center - Minneapolis
      • Robbinsdale, Minnesota, 미국, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, 미국, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, 미국, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, 미국, 55102
        • United Hospital
      • Saint Paul, Minnesota, 미국, 55102
        • HealthEast Cancer Care at St. Joseph's Hospital
      • Shakopee, Minnesota, 미국, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • St. Paul, Minnesota, 미국, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, 미국, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, 미국, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
      • Woodbury, Minnesota, 미국, 55125
        • HealthEast Cancer Care at Woodwinds Health Campus
    • Missouri
      • Saint Louis, Missouri, 미국, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, 미국, 63141
        • Arch Medical Services, Incorporated at Center for Cancer Care and Research
    • Montana
      • Billings, Montana, 미국, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, 미국, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, 미국, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, 미국, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, 미국, 59107-7000
        • Billings Clinic - Downtown
      • Bozeman, Montana, 미국, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, 미국, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, 미국, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, 미국, 59405
      • Havre, Montana, 미국, 59501
        • Northern Montana Hospital
      • Helena, Montana, 미국, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, 미국, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, 미국, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, 미국, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, 미국, 59801
        • Community Medical Center
      • Missoula, Montana, 미국, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, 미국, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, 미국, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Omaha, Nebraska, 미국, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, 미국, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, 미국, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, 미국, 68131-2197
        • Creighton University Medical Center
    • New York
      • Buffalo, New York, 미국, 14263-0001
        • Roswell Park Cancer Institute
    • North Dakota
      • Bismarck, North Dakota, 미국, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, 미국, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, 미국, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, 미국, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, 미국, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, 미국, 58122
        • MeritCare Broadway
      • Grand Forks, North Dakota, 미국, 58201
        • Altru Cancer Center at Altru Hospital
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, 미국, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Danville, Pennsylvania, 미국, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hazleton, Pennsylvania, 미국, 18201
        • Geisinger Hazleton Cancer Center
      • State College, Pennsylvania, 미국, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, 미국, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Wilkes-Barre, Pennsylvania, 미국, 18765
        • Mercy Hospital at Wilkes-Barre
    • South Dakota
      • Rapid City, South Dakota, 미국, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, 미국, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, 미국, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, 미국, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, 미국, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, 미국, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, 미국, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, 미국, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • La Crosse, Wisconsin, 미국, 54601
        • Franciscan Skemp Healthcare - La Crosse Campus
      • Marinette, Wisconsin, 미국, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, 미국, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, 미국, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
    • Wyoming
      • Sheridan, Wyoming, 미국, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

DISEASE CHARACTERISTICS:

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

    • Squamous cell histology allowed
    • No mixed histology with small cell component

  • Stage IIIB (with pleural effusion) or stage IV disease

    • Presence of peritoneal or pericardial effusion alone in the absence of cytologic evidence is not allowed

  • Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan

    • If the only site of measurable disease was previously irradiated, progressive disease must be evident
  • Ineligible for bevacizumab therapy

  • No symptomatic, untreated, or uncontrolled CNS metastases

    • CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after completion of WBRT

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • ALT and AST ≤ 3 times ULN (5 times ULN if liver involvement)
  • Alkaline phosphatase ≤ 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No proteinuria ≥ 1+
  • No uncontrolled blood pressure (BP), defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg in spite of adequate antihypertensive therapy
  • No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection)
  • No seizure disorder
  • No significant traumatic injury within 4 weeks prior to study entry

  • No second primary malignancy except any of the following:

    • Carcinoma in situ of the cervix
    • Nonmelanoma skin cancer
    • Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
    • History of low-grade (Gleason score ≤ 6) localized prostate cancer even if diagnosed < 5 years prior to registration
    • Treated stage I breast cancer ≤ 5 years prior to registration

  • No uncontrolled intercurrent illness, including, but not limited to, any of the following:

    • Ongoing or active infection
    • Significant pulmonary symptoms at baseline due to disease
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance with study requirements
    • Baseline hemoptysis
    • Cavitating lesions
  • No QTc prolongation > 500 msec or other significant ECG abnormality within the past 14 days
  • No New York Heart Association class III or IV disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior chemotherapy for advanced lung cancer

    • Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months allowed
  • More than 12 months since prior immunotherapy and biologic therapy
  • More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
  • At least 2 weeks since prior WBRT
  • No radiotherapy to ≥ 25% of bone marrow

  • No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study entry (2 weeks for minor surgery)

    • Insertion of a vascular access device not considered major or minor surgery
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent grapefruit or grapefruit juice during AZD2171 treatment
  • No concurrent drugs or biologics with proarrhythmic potential
  • Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of radiotherapy)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
의약품: 젬시타빈염산염
주어진 IV
의약품: 카보플라틴
주어진 IV
의약품: 세디라닙 말레이트
구두로 주어진
활성 비교기: Arm II
Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
의약품: 젬시타빈염산염
주어진 IV
의약품: 카보플라틴
주어진 IV

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
기간: Up to 5 years

A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 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
Up to 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
기간: 6 months

Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
6 months
Progression-free Survival (Phase II Patients Only)
기간: Up to 5 years
Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.
Up to 5 years
Time to Treatment Failure (Phase II Patients Only)
기간: Up to 15 months
Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.
Up to 15 months
Overall Survival at 1 Year After Randomization (Phase II Patients Only)
기간: 1 year
Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.
1 year
Overall Survival (Phase II Patients Only)
기간: Up to 5 years
Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.
Up to 5 years
Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)
기간: Cycle 1 (up to 3 weeks)
DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities.
Cycle 1 (up to 3 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 6월 1일

기본 완료 (실제)

2009년 4월 1일

연구 완료 (실제)

2010년 2월 1일

연구 등록 날짜

최초 제출

2006년 5월 16일

QC 기준을 충족하는 최초 제출

2006년 5월 16일

처음 게시됨 (추정)

2006년 5월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 3월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 16일

마지막으로 확인됨

2017년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCCTG-N0528
  • NCI-2012-02694 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
  • CDR0000468945 (레지스트리 식별자: PDQ (Physician Data Query))

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

폐암에 대한 임상 시험

젬시타빈염산염에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Paraguay

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다