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Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

20. juni 2013 opdateret af: Southwest Oncology Group

A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Nyrekræft

Intervention / Behandling

Medicin: alvocidib

Detaljeret beskrivelse

OBJECTIVES:

Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol.
Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug.
Determine the qualitative and quantitative toxic effects of this drug in this patient population.
Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile, Alabama, Forenede Stater, 36688
    - MBCCOP - Gulf Coast
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85006-2726
    - CCOP - Greater Phoenix
  - Phoenix, Arizona, Forenede Stater, 85012
    - Veterans Affairs Medical Center - Phoenix (Hayden)
  - Tucson, Arizona, Forenede Stater, 85724
    - Arizona Cancer Center
  - Tucson, Arizona, Forenede Stater, 85723
    - Veterans Affairs Medical Center - Tucson
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Duarte, California, Forenede Stater, 91010-3000
    - Cancer Center and Beckman Research Institute, City of Hope
  - Los Angeles, California, Forenede Stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Forenede Stater, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Los Angeles, California, Forenede Stater, 90073
    - Veterans Affairs Medical Center - West Los Angeles
  - Martinez, California, Forenede Stater, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, Forenede Stater, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center
  - Sacramento, California, Forenede Stater, 95817
    - University of California Davis Medical Center
  - Sacramento, California, Forenede Stater, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, Forenede Stater, 94121
    - Veterans Affairs Medical Center - San Francisco
  - San Francisco, California, Forenede Stater, 94143-0128
    - UCSF Cancer Center and Cancer Research Institute
  - Santa Rosa, California, Forenede Stater, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base, California, Forenede Stater, 94535
    - David Grant Medical Center
- Colorado
  - Denver, Colorado, Forenede Stater, 80220
    - Veterans Affairs Medical Center - Denver
  - Denver, Colorado, Forenede Stater, 80010
    - University of Colorado Cancer Center
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30342-1701
    - CCOP - Atlanta Regional
  - Fort Gordon, Georgia, Forenede Stater, 30905-5650
    - Dwight David Eisenhower Army Medical Center
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Cancer Research Center of Hawaii
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612-7323
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, Forenede Stater, 60612
    - Veterans Affairs Medical Center - Chicago (Westside Hospital)
  - Decatur, Illinois, Forenede Stater, 62526
    - CCOP - Central Illinois
  - Hines, Illinois, Forenede Stater, 60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood, Illinois, Forenede Stater, 60153
    - Loyola University Medical Center
- Kansas
  - Kansas City, Kansas, Forenede Stater, 66160-7357
    - University of Kansas Medical Center
  - Wichita, Kansas, Forenede Stater, 67214-3882
    - CCOP - Wichita
  - Wichita, Kansas, Forenede Stater, 67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40511-1093
    - Veterans Affairs Medical Center - Lexington
  - Lexington, Kentucky, Forenede Stater, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Veterans Affairs Medical Center - New Orleans
  - New Orleans, Louisiana, Forenede Stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, Forenede Stater, 71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport, Louisiana, Forenede Stater, 71130
    - Veterans Affairs Medical Center - Shreveport
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02118
    - Boston Medical Center
  - Jamaica Plain, Massachusetts, Forenede Stater, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109-0752
    - University Of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, Forenede Stater, 48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, Forenede Stater, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Detroit, Michigan, Forenede Stater, 48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids Clinical Oncology Program
  - Southfield, Michigan, Forenede Stater, 48075-9975
    - Providence Hospital - Southfield
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55805
    - CCOP - Duluth
- Mississippi
  - Biloxi, Mississippi, Forenede Stater, 39531-2410
    - Veterans Affairs Medical Center - Biloxi
  - Jackson, Mississippi, Forenede Stater, 39216-4505
    - University of Mississippi Medical Center
  - Jackson, Mississippi, Forenede Stater, 39216
    - Veterans Affairs Medical Center - Jackson
  - Keesler AFB, Mississippi, Forenede Stater, 39534-2576
    - Keesler Medical Center - Keesler AFB
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63110-0250
    - St. Louis University Health Sciences Center
  - Saint Louis, Missouri, Forenede Stater, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Springfield, Missouri, Forenede Stater, 65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque, New Mexico, Forenede Stater, 87131
    - MBCCOP - University of New Mexico HSC
- New York
  - Albany, New York, Forenede Stater, 12208
    - Veterans Affairs Medical Center - Albany
  - New York, New York, Forenede Stater, 10032
    - Herbert Irving Comprehensive Cancer Center
  - Rochester, New York, Forenede Stater, 14642
    - University of Rochester Medical Center
- North Carolina
  - Winston-Salem, North Carolina, Forenede Stater, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cincinnati, Ohio, Forenede Stater, 45267-0502
    - Barrett Cancer Center, The University Hospital
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, Forenede Stater, 43206
    - CCOP - Columbus
  - Dayton, Ohio, Forenede Stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Kettering, Ohio, Forenede Stater, 45429
    - CCOP - Dayton
  - Toledo, Ohio, Forenede Stater, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Oklahoma Medical Research Foundation
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Veterans Affairs Medical Center - Oklahoma City
- Oregon
  - Portland, Oregon, Forenede Stater, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, Forenede Stater, 97213
    - CCOP - Columbia River Program
  - Portland, Oregon, Forenede Stater, 97201-3098
    - Oregon Cancer Center
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425-0721
    - Medical University of South Carolina
  - Charleston, South Carolina, Forenede Stater, 29401-5799
    - Veterans Affairs Medical Center - Charleston
  - Greenville, South Carolina, Forenede Stater, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - CCOP - Upstate Carolina
- Texas
  - Fort Sam Houston, Texas, Forenede Stater, 78234
    - Brooke Army Medical Center
  - Galveston, Texas, Forenede Stater, 77555-0209
    - University of Texas Medical Branch
  - Houston, Texas, Forenede Stater, 77030
    - Baylor College of Medicine
  - Houston, Texas, Forenede Stater, 77030
    - Veterans Affairs Medical Center - Houston
  - Lubbock, Texas, Forenede Stater, 79415
    - Texas Tech University Health Science Center
  - San Antonio, Texas, Forenede Stater, 78284-7811
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Forenede Stater, 78284
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - Temple, Texas, Forenede Stater, 76504
    - Veterans Affairs Medical Center - Temple
  - Temple, Texas, Forenede Stater, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84148
    - Veterans Affairs Medical Center - Salt Lake City
  - Salt Lake City, Utah, Forenede Stater, 84112
    - Huntsman Cancer Institute
- Virginia
  - Norfolk, Virginia, Forenede Stater, 23507
    - Eastern Virginia Medical School
- Washington
  - Seattle, Washington, Forenede Stater, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, Forenede Stater, 98104
    - Swedish Cancer Institute
  - Seattle, Washington, Forenede Stater, 98108
    - Veterans Affairs Medical Center - Seattle
  - Tacoma, Washington, Forenede Stater, 98431-5000
    - Madigan Army Medical Center
  - Tacoma, Washington, Forenede Stater, 98405-0986
    - CCOP - Northwest

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable
- Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field
No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

No hypercoagulable state other than renal cell cancer

Hepatic:

Not specified

Renal:

Not specified

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No prior isolated occurrence of deep venous thrombosis within the past 6 months

Pulmonary:

No prior isolated occurrence of pulmonary embolism within the past 6 months

Other:

No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I)
No other uncontrolled illness (e.g., diabetes mellitus)
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed
At least 28 days since prior immunotherapy and recovered
No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

No prior chemotherapy for renal cell cancer

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
At least 21 days since prior radiotherapy and recovered

Surgery:

See Disease Characteristics
Prior resection of primary tumor allowed
At least 28 days since prior surgery and recovered

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Peter J. VanVeldhuizen, MD, Kansas City Veteran Affairs Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Van Veldhuizen PJ, Faulkner JR, Lara PN Jr, Gumerlock PH, Goodwin JW, Dakhil SR, Gross HM, Flanigan RC, Crawford ED; Southwest Oncology Group. A phase II study of flavopiridol in patients with advanced renal cell carcinoma: results of Southwest Oncology Group Trial 0109. Cancer Chemother Pharmacol. 2005 Jul;56(1):39-45. doi: 10.1007/s00280-004-0969-9. Epub 2005 Mar 25.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2001

Primær færdiggørelse

7. december 2022

Studieafslutning (Faktiske)

1. april 2006

Datoer for studieregistrering

Først indsendt

6. juni 2001

Først indsendt, der opfyldte QC-kriterier

8. september 2003

Først opslået (Skøn)

9. september 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2013

Sidst verificeret

1. januar 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000068634
SWOG-S0109

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .