NCT00065468

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 626 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Renal Cell
• Kidney Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-07-01
• Primary completion: 2006-06-01
• Completion: 2011-03-01
• First posted: 2003-07-25
• Last updated: 2012-10-25
• Results posted: 2012-10-25

Locations

153 sites across 25 countries: United States, Argentina, Australia, Canada, Czechia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Russia, Serbia and Montenegro, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom