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

Completed · Phase 3

Conditions studied: Carcinoma, Renal Cell, Kidney Neoplasms

In brief

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.

Key facts

Study ID

NCT00065468

Run by

Pfizer

People needed

626

Starts

2003-07-01

Expected to finish

2011-03-01

Last updated by the study team

2012-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,

You may not qualify if…

• Subjects with central nervous system (CNS) metastases
• Prior anticancer therapy for RCC
• Prior investigational therapy/agents within 4 weeks of randomization

Where it is running

• Pfizer Investigational Site — La Verne, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Waterbury, Connecticut, United States
• Pfizer Investigational Site — Boca Raton, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Urbana, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — South Bend, Indiana, United States
• Pfizer Investigational Site — Terre Haute, Indiana, United States
• Pfizer Investigational Site — Kansas City, Kansas, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Kansas City, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Billings, Montana, United States
• Pfizer Investigational Site — Great Falls, Montana, United States
• Pfizer Investigational Site — Lebanon, New Hampshire, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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