Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

Last updated: September 24, 2012
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Urothelial Tract Cancer

Carcinoma

Urothelial Cancer

Treatment

Interferon Alfa

Interferon Alfa and CCI-779

CCI-779

Clinical Study ID

NCT00065468
3066K1-304
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus], administered intravenously [IV] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy fortheir disease,

Exclusion

Exclusion Criteria:

  • Subjects with central nervous system (CNS) metastases

  • Prior anticancer therapy for RCC

  • Prior investigational therapy/agents within 4 weeks of randomization

Study Design

Total Participants: 626
Treatment Group(s): 3
Primary Treatment: Interferon Alfa
Phase: 3
Study Start date:
July 01, 2003
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • Pfizer Investigational Site

    Buenos, Aires
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    San Miguel de Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Buenos Aires, C1426ANZ
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Cordoba, 5000
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Mendoza,
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Quilmes,
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Unknown,
    Argentina

    Site Not Available

  • Pfizer Investigational Site

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Newcastle, New South Wales
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Footscray, Victoria 3012
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Melbourne, Victoria 3050
    Australia

    Site Not Available

  • Pfizer Investigational Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Kelowna, British Columbia V1Y 5L3
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Vancouver, British Columbia V5Z 3J5
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Winnipeg, Manitoba R3E 0C9
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Pfizer Investigational Site

    London, Ontario N6A 4L5
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Quebec City, Quebec G1R 2J6
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Hamilton, Ontario, L8N 4A6
    Canada

    Site Not Available

  • Pfizer Investigational Site

    Brno, 656 53
    Czech Republic

    Site Not Available

  • Pfizer Investigational Site

    Prague 5, 150 00
    Czech Republic

    Site Not Available

  • Pfizer Investigational Site

    Sremska Kamenica, Novi Sad 21204
    Former Serbia and Montenegro

    Site Not Available

  • Pfizer Investigational Site

    Bonn, NRW 53105
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Essen, NRW 45122
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Mainz, RP D-55101
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Heraklion, Creete
    Greece

    Site Not Available

  • Pfizer Investigational Site

    Patra,
    Greece

    Site Not Available

  • Pfizer Investigational Site

    Budapest, H-1122
    Hungary

    Site Not Available

  • Pfizer Investigational Site

    Roma, RM 00144
    Italy

    Site Not Available

  • Pfizer Investigational Site

    Foggia, 71100
    Italy

    Site Not Available

  • Pfizer Investigational Site

    Milano, 20132
    Italy

    Site Not Available

  • Pfizer Investigational Site

    Daugavpils,
    Latvia

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  • Pfizer Investigational Site

    Riga, 1002
    Latvia

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  • Pfizer Investigational Site

    Vilnius, 2021
    Lithuania

    Site Not Available

  • Pfizer Investigational Site

    Monterrey, Nuevo Leon 64000
    Mexico

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  • Pfizer Investigational Site

    Leon Guanajuato, 37000
    Mexico

    Site Not Available

  • Pfizer Investigational Site

    Nijmegen, GA 6525
    Netherlands

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  • Pfizer Investigational Site

    Amsterdam, 1105 AZ
    Netherlands

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  • Pfizer Investigational Site

    Enschede, 7511 JX
    Netherlands

    Site Not Available

  • Pfizer Investigational Site

    Bytom, 41-902
    Poland

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  • Pfizer Investigational Site

    Lodz, 93-509
    Poland

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  • Pfizer Investigational Site

    Lublin, 20-090
    Poland

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  • Pfizer Investigational Site

    Olsztyn, 10-228
    Poland

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  • Pfizer Investigational Site

    Opole, 45-060
    Poland

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  • Pfizer Investigational Site

    Poznan, 61-878
    Poland

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  • Pfizer Investigational Site

    Siedlce, 08-110
    Poland

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  • Pfizer Investigational Site

    Warszawa, 00-909
    Poland

    Site Not Available

  • Pfizer Investigational Site

    Barnaul, 656052
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Kemerovo, 650003
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Moscow, 121356
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Obninsk, 249036
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Saint Petersburg, 188663
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    St Petersburg, 197758
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Ufa, 450005
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Pfizer Investigational Site

    Banska Bystrica, 974 01
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Martin, 03659
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Zlina, 012 07
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Port Elizabeth, Eastern Cape 6006
    South Africa

    Site Not Available

  • Pfizer Investigational Site

    Johannesburg, Gauteng 2197
    South Africa

    Site Not Available

  • Pfizer Investigational Site

    Cape Town, 7505
    South Africa

    Site Not Available

  • Pfizer Investigational Site

    Gauteng,
    South Africa

    Site Not Available

  • Pfizer Investigational Site

    Oviedo, Asturias 33006
    Spain

    Site Not Available

  • Pfizer Investigational Site

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Pfizer Investigational Site

    Barcelona, 08025
    Spain

    Site Not Available

  • Pfizer Investigational Site

    Madrid, 28040
    Spain

    Site Not Available

  • Pfizer Investigational Site

    Göteborg, 41345
    Sweden

    Site Not Available

  • Pfizer Investigational Site

    Göteborg, 41345
    Sweden

    Site Not Available

  • Pfizer Investigational Site

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Pfizer Investigational Site

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Pfizer Investigational Site

    Taichung,
    Taiwan

    Site Not Available

  • Pfizer Investigational Site

    Taipei, 104
    Taiwan

    Site Not Available

  • Pfizer Investigational Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Pfizer Investigational Site

    Istanbul,
    Turkey

    Site Not Available

  • Pfizer Investigational Site

    Izmir, 35100
    Turkey

    Site Not Available

  • Pfizer Investigational Site

    Dnietropetrovsk,
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Donetsk, 83 092
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Kharkov, 61 037
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Kiev, 03 142
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Lviv, 79031
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Zaporozhye, 69103
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Manchester, Lancashire M20 4BX
    United Kingdom

    Site Not Available

  • Pfizer Investigational Site

    Glasgow, Strathclyde G11 6NT
    United Kingdom

    Site Not Available

  • Pfizer Investigational Site

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Pfizer Investigational Site

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Pfizer Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Pfizer Investigational Site

    La Verne, California 91750
    United States

    Site Not Available

  • Pfizer Investigational Site

    Los Angeles, California 90024-2828
    United States

    Site Not Available

  • Pfizer Investigational Site

    San Diego, California 92123
    United States

    Site Not Available

  • Pfizer Investigational Site

    San Francisco, California 94115
    United States

    Site Not Available

  • Pfizer Investigational Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Pfizer Investigational Site

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Pfizer Investigational Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Pfizer Investigational Site

    Chicago, Illinois 60612-3824
    United States

    Site Not Available

  • Pfizer Investigational Site

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Pfizer Investigational Site

    Indianapolis, Indiana 46303
    United States

    Site Not Available

  • Pfizer Investigational Site

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Pfizer Investigational Site

    Terre Haute, Indiana 47802
    United States

    Site Not Available

  • Pfizer Investigational Site

    Kansas City, Kansas 66160-7136
    United States

    Site Not Available

  • Pfizer Investigational Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Pfizer Investigational Site

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Pfizer Investigational Site

    Baltimore, Maryland 21231-1000
    United States

    Site Not Available

  • Pfizer Investigational Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Pfizer Investigational Site

    Ann Arbor, Michigan 48109-0942
    United States

    Site Not Available

  • Pfizer Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Pfizer Investigational Site

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Pfizer Investigational Site

    Billings, Montana 59101
    United States

    Site Not Available

  • Pfizer Investigational Site

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Pfizer Investigational Site

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • Pfizer Investigational Site

    East Orange, New Jersey 07018
    United States

    Site Not Available

  • Pfizer Investigational Site

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Pfizer Investigational Site

    Bronx, New York 10466
    United States

    Site Not Available

  • Pfizer Investigational Site

    New York, New York 10021
    United States

    Site Not Available

  • Pfizer Investigational Site

    Rochester, New York 14642
    United States

    Site Not Available

  • Pfizer Investigational Site

    Valhalla, New York 10595
    United States

    Site Not Available

  • Pfizer Investigational Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Pfizer Investigational Site

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Pfizer Investigational Site

    Portland, Oregon 97213-2933
    United States

    Site Not Available

  • Pfizer Investigational Site

    Hershey, Pennsylvania 17033-0850
    United States

    Site Not Available

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Pfizer Investigational Site

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Pfizer Investigational Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Pfizer Investigational Site

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Pfizer Investigational Site

    Nashville, Tennessee 37232-6310
    United States

    Site Not Available

  • Pfizer Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Pfizer Investigational Site

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Pfizer Investigational Site

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Pfizer Investigational Site

    Seattle, Washington 98101
    United States

    Site Not Available

  • Pfizer Investigational Site

    ,

    Site Not Available

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