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


Phase 2
N/A
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter J. VanVeldhuizen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kansas City Veteran Affairs Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000068634

NCT ID:

NCT00016939

Start Date:

May 2001

Completion Date:

April 2006

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Rochester Medical CenterRochester, New York  14642
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Oregon Cancer CenterPortland, Oregon  97201-3098
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
University of California Davis Cancer CenterSacramento, California  95817