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Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

2011년 8월 3일 업데이트: Pfizer

A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.

The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

317

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Arkansas
      • Hot Springs, Arkansas, 미국, 71913
        • Pfizer Investigational Site
      • Little Rock, Arkansas, 미국, 72205
        • Pfizer Investigational Site
    • California
      • Anaheim, California, 미국, 92807
        • Pfizer Investigational Site
      • Baldwin Park, California, 미국, 91706
        • Pfizer Investigational Site
      • Bellflower, California, 미국, 90706
        • Pfizer Investigational Site
      • Duarte, California, 미국, 91010
        • Pfizer Investigational Site
      • Fontana, California, 미국, 92335
        • Pfizer Investigational Site
      • Irvine, California, 미국, 92618
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90027
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90034
        • Pfizer Investigational Site
      • Panorama City, California, 미국, 91402
        • Pfizer Investigational Site
      • Riverside, California, 미국, 92505
        • Pfizer Investigational Site
      • San Diego, California, 미국, 92108
        • Pfizer Investigational Site
      • San Diego, California, 미국, 92120
        • Pfizer Investigational Site
      • Woodland Hills, California, 미국, 91365
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, 미국, 80012
        • Pfizer Investigational Site
      • Boulder, Colorado, 미국, 80304
        • Pfizer Investigational Site
      • Boulder, Colorado, 미국, 80303
        • Pfizer Investigational Site
      • Colorado Springs, Colorado, 미국, 80909
        • Pfizer Investigational Site
      • Denver, Colorado, 미국, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, 미국, 80218
        • Pfizer Investigational Site
      • Lakewood, Colorado, 미국, 80228
        • Pfizer Investigational Site
      • Littleton, Colorado, 미국, 80120
        • Pfizer Investigational Site
      • Lone Tree, Colorado, 미국, 80124
        • Pfizer Investigational Site
      • Longmont, Colorado, 미국, 80501
        • Pfizer Investigational Site
      • Parker, Colorado, 미국, 80138
        • Pfizer Investigational Site
      • Pueblo, Colorado, 미국, 81008
        • Pfizer Investigational Site
      • Thorton, Colorado, 미국, 80260
        • Pfizer Investigational Site
    • Connecticut
      • Norwich, Connecticut, 미국, 06360
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, 미국, 19718
        • Pfizer Investigational Site
      • Newark, Delaware, 미국, 19713
        • Pfizer Investigational Site
      • Wilmington, Delaware, 미국, 19899
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, 미국, 33486
        • Pfizer Investigational Site
      • Delray Beach, Florida, 미국, 33484
        • Pfizer Investigational Site
      • Lakeland, Florida, 미국, 33805
        • Pfizer Investigational Site
      • Orlando, Florida, 미국, 32806
        • Pfizer Investigational Site
    • Georgia
      • Columbus, Georgia, 미국, 31902
        • Pfizer Investigational Site
      • Columbus, Georgia, 미국, 31904
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, 미국, 83712
        • Pfizer Investigational Site
    • Indiana
      • Elkhart, Indiana, 미국, 46514
        • Pfizer Investigational Site
      • Jefferson, Indiana, 미국, 47130
        • Pfizer Investigational Site
      • Kokomo, Indiana, 미국, 46902-3803
        • Pfizer Investigational Site
      • La Porte, Indiana, 미국, 46350
        • Pfizer Investigational Site
      • LaPorte, Indiana, 미국, 46350
        • Pfizer Investigational Site
      • LaPorte, Indiana, 미국, 46350-5533
        • Pfizer Investigational Site
      • Michigan City, Indiana, 미국, 46360
        • Pfizer Investigational Site
      • Plymouth, Indiana, 미국, 46563
        • Pfizer Investigational Site
      • South Bend, Indiana, 미국, 46601
        • Pfizer Investigational Site
      • South Bend, Indiana, 미국, 46617
        • Pfizer Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, 미국, 52402
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, 미국, 40536
        • Pfizer Investigational Site
      • Lexington, Kentucky, 미국, 40536-0293
        • Pfizer Investigational Site
      • Louisville, Kentucky, 미국, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, 미국, 40217
        • Pfizer Investigational Site
      • Louisville, Kentucky, 미국, 40207
        • Pfizer Investigational Site
      • Shelbyville, Kentucky, 미국, 40065
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70809
        • Pfizer Investigational Site
      • Covington, Louisiana, 미국, 70433
        • Pfizer Investigational Site
      • Gretna, Louisiana, 미국, 70056
        • Pfizer Investigational Site
      • Marrero, Louisiana, 미국, 70072
        • Pfizer Investigational Site
      • Metairie, Louisiana, 미국, 70006
        • Pfizer Investigational Site
      • New Orleans, Louisiana, 미국, 70115
        • Pfizer Investigational Site
      • Shreveport, Louisiana, 미국, 71103
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • Pfizer Investigational Site
      • Baltimore, Maryland, 미국, 21237
        • Pfizer Investigational Site
      • Bethesda, Maryland, 미국, 20817
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, 미국, 49503
        • Pfizer Investigational Site
      • Holland, Michigan, 미국, 49424
        • Pfizer Investigational Site
      • Niles, Michigan, 미국, 49120
        • Pfizer Investigational Site
      • Saint Joseph, Michigan, 미국, 49085
        • Pfizer Investigational Site
      • St. Joseph, Michigan, 미국, 49085
        • Pfizer Investigational Site
      • St. Joseph, Michigan, 미국, 49085-2112
        • Pfizer Investigational Site
      • St. Joseph, Michigan, 미국, 49085-2158
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, 미국, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, 미국, 63141
        • Pfizer Investigational Site
      • Washington, Missouri, 미국, 63090
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, 미국, 89052
        • Pfizer Investigational Site
      • Las Vegas, Nevada, 미국, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, 미국, 89148
        • Pfizer Investigational Site
      • Las Vegas, Nevada, 미국, 89135
        • Pfizer Investigational Site
      • Las Vegas, Nevada, 미국, 89169
        • Pfizer Investigational Site
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87131-0001
        • Pfizer Investigational Site
      • Farmington, New Mexico, 미국, 87401-5631
        • Pfizer Investigational Site
    • New York
      • Albany, New York, 미국, 12206
        • Pfizer Investigational Site
      • Albany, New York, 미국, 12208
        • Pfizer Investigational Site
      • Amsterdam, New York, 미국, 12010
        • Pfizer Investigational Site
      • Brockport, New York, 미국, 14420
        • Pfizer Investigational Site
      • Canadaigua, New York, 미국, 14424
        • Pfizer Investigational Site
      • Geneva, New York, 미국, 14456
        • Pfizer Investigational Site
      • Hudson, New York, 미국, 12534
        • Pfizer Investigational Site
      • Latham, New York, 미국, 12110
        • Pfizer Investigational Site
      • New York, New York, 미국, 10021
        • Pfizer Investigational Site
      • New York, New York, 미국, 10032
        • Pfizer Investigational Site
      • New York, New York, 미국, 10022
        • Pfizer Investigational Site
      • Rexford, New York, 미국, 12148
        • Pfizer Investigational Site
      • Rochester, New York, 미국, 14623
        • Pfizer Investigational Site
      • Rochester, New York, 미국, 14626
        • Pfizer Investigational Site
      • Troy, New York, 미국, 12180
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, 미국, 27518
        • Pfizer Investigational Site
      • Clinton, North Carolina, 미국, 28328
        • Pfizer Investigational Site
      • Elizabeth City, North Carolina, 미국, 27909
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, 미국, 27534
        • Pfizer Investigational Site
      • Hickory, North Carolina, 미국, 28602
        • Pfizer Investigational Site
      • Raleigh, North Carolina, 미국, 27607
        • Pfizer Investigational Site
      • Raleigh, North Carolina, 미국, 27614
        • Pfizer Investigational Site
      • Wilson, North Carolina, 미국, 27893
        • Pfizer Investigational Site
    • Ohio
      • Canton, Ohio, 미국, 44718
        • Pfizer Investigational Site
      • Columbus, Ohio, 미국, 43219
        • Pfizer Investigational Site
    • Oklahoma
      • Norman, Oklahoma, 미국, 73071
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, 미국, 73120
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, 미국, 73102
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, 미국, 73109
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, 미국, 73112-4416
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, 미국, 74133
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, 미국, 74104
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, 미국, 74136-1902
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, 미국, 97401
        • Pfizer Investigational Site
      • Springfield, Oregon, 미국, 97477
        • Pfizer Investigational Site
    • Pennsylvania
      • Dunmore, Pennsylvania, 미국, 18512-3169
        • Pfizer Investigational Site
      • Lemoyne, Pennsylvania, 미국, 17043-1440
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, 미국, 19111-2497
        • Pfizer Investigational Site
      • Scranton, Pennsylvania, 미국, 18508
        • Pfizer Investigational Site
    • South Carolina
      • Easley, South Carolina, 미국, 29640
        • Pfizer Investigational Site
      • Greenville, South Carolina, 미국, 29615
        • Pfizer Investigational Site
      • Greenville, South Carolina, 미국, 29605
        • Pfizer Investigational Site
      • Seneca, South Carolina, 미국, 29672
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, 미국, 29307
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, 미국, 78705
        • Pfizer Investigational Site
      • Austin, Texas, 미국, 78745
        • Pfizer Investigational Site
      • Austin, Texas, 미국, 78759
        • Pfizer Investigational Site
      • Austin, Texas, 미국, 78731
        • Pfizer Investigational Site
      • Austin, Texas, 미국, 78758
        • Pfizer Investigational Site
      • Bedford, Texas, 미국, 76022
        • Pfizer Investigational Site
      • Corpus Christi, Texas, 미국, 78463
        • Pfizer Investigational Site
      • Dallas, Texas, 미국, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, 미국, 75246
        • Pfizer Investigational Site
      • Fort Worth, Texas, 미국, 76177
        • Pfizer Investigational Site
      • Georgetown, Texas, 미국, 78626
        • Pfizer Investigational Site
      • Round Rock, Texas, 미국, 78681
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78207
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78258
        • Pfizer Investigational Site
      • Tyler, Texas, 미국, 75702
        • Pfizer Investigational Site
      • Webster, Texas, 미국, 77598
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • Pfizer Investigational Site
    • Virginia
      • Chesapeake, Virginia, 미국, 23320
        • Pfizer Investigational Site
      • Hampton, Virginia, 미국, 23666
        • Pfizer Investigational Site
      • Newport News, Virginia, 미국, 23601
        • Pfizer Investigational Site
      • Newport News, Virginia, 미국, 23502
        • Pfizer Investigational Site
      • Norfolk, Virginia, 미국, 23502
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, 미국, 23456
        • Pfizer Investigational Site
      • Williamsburg, Virginia, 미국, 23188
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, 미국, 98195
        • Pfizer Investigational Site
      • Seattle, Washington, 미국, 98109
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, 미국, 26506
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, 미국, 53792
        • Pfizer Investigational Site

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

Inclusion Criteria:

  • Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
  • Measurable disease

Exclusion Criteria:

  • Prior systemic therapy of any kind for advanced renal cell cancer
  • History of brain metastases
  • Uncontrolled hypertension

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: ㅏ
의약품: Sunitinib Malate Schedule 4/2
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.
실험적: 씨
의약품: Sunitinib Malate Continuous Daily Dosing
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
기간: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Objective Response (OR)
기간: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Duration of Response (DR)
기간: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model
기간: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

기타 결과 측정

결과 측정
측정값 설명
기간
Functional Assessment of Cancer Therapy-General (FACT-G)
기간: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)
기간: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.

The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

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

유용한 링크

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

2005년 12월 1일

기본 완료 (실제)

2010년 6월 1일

연구 완료 (실제)

2010년 6월 1일

연구 등록 날짜

최초 제출

2005년 12월 20일

QC 기준을 충족하는 최초 제출

2005년 12월 20일

처음 게시됨 (추정)

2005년 12월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 9월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 8월 3일

마지막으로 확인됨

2011년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A6181065

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