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

NCT00065468

Last updated date
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma, Kidney Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects with central nervous system (CNS) metastases


- Prior anticancer therapy for RCC


- Prior investigational therapy/agents within 4 weeks of randomization

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Renal Cell Carcinoma, Kidney NeoplasmsStudy Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma NCT00065468
  1. Little Rock, Arkansas
  2. La Verne, California
  3. Los Angeles, California
  4. San Diego, California
  5. San Francisco, California
  6. Waterbury, Connecticut
  7. Boca Raton, Florida
  8. Miami, Florida
  9. Chicago, Illinois
  10. Urbana, Illinois
  11. Indianapolis, Indiana
  12. South Bend, Indiana
  13. Terre Haute, Indiana
  14. Kansas City, Kansas
  15. Louisville, Kentucky
  16. New Orleans, Louisiana
  17. Baltimore, Maryland
  18. Boston, Massachusetts
  19. Ann Arbor, Michigan
  20. Detroit, Michigan
  21. Kansas City, Missouri
  22. St. Louis, Missouri
  23. Billings, Montana
  24. Great Falls, Montana
  25. Lebanon, New Hampshire
  26. East Orange, New Jersey
  27. Morristown, New Jersey
  28. Bronx, New York
  29. New York, New York
  30. Rochester, New York
  31. Valhalla, New York
  32. Durham, North Carolina
  33. Hickory, North Carolina
  34. Cleveland, Ohio
  35. Oklahoma City, Oklahoma
  36. Portland, Oregon
  37. Hershey, Pennsylvania
  38. Philadelphia, Pennsylvania
  39. Pittsburgh, Pennsylvania
  40. Charleston, South Carolina
  41. Knoxville, Tennessee
  42. Memphis, Tennessee
  43. Nashville, Tennessee
  44. Houston, Texas
  45. Salt Lake City, Utah
  46. Richmond, Virginia
  47. Seattle, Washington
  48. Seattle, Washington
  49. Buenos, Aires
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  51. Buenos Aires,
  52. Cordoba,
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  56. Newcastle, New South Wales
  57. Westmead, New South Wales
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  68. Newmarket, Ontario
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  70. Toronto, Ontario
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  72. Montreal, Quebec
  73. Montreal, Quebec
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  81. Bonn, NRW
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  150. Manchester, Lancashire
  151. Glasgow, Strathclyde
  152. Sutton, Surrey
  153. Nottingham,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Official Title  ICMJE A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
Intervention  ICMJE
  • Drug: Interferon Alfa
    Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.
  • Drug: CCI-779
    25 mg of CCI-779 given Intra Venously once per week
  • Drug: Interferon Alfa and CCI-779
    15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Interferon Alfa
  • Experimental: B
    Intervention: Drug: CCI-779
  • Experimental: C
    Intervention: Drug: Interferon Alfa and CCI-779
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2007)
626
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 for their disease,

Exclusion Criteria:

  • Subjects with central nervous system (CNS) metastases
  • Prior anticancer therapy for RCC
  • Prior investigational therapy/agents within 4 weeks of randomization
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Czech Republic,   Former Serbia and Montenegro,   Germany,   Greece,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00065468
Other Study ID Numbers  ICMJE 3066K1-304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP