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

NCT00065468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2012-10-25

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2006-06-30
Completion
2011-03-31

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00065468 on ClinicalTrials.gov