Study Comparing Bevacizumab + Temsirolimus Vs Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (INTORACT)


Tracking Information

Start Date  ICMJEMarch 2008
Estimated Primary Completion DateFebruary 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 28, 2008)		Tumor measurements and survival status [ Time Frame: On going ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00631371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 28, 2008)		Safety, investigator Assessed PFS, objective response rate, survival [ Time Frame: On going ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy Comparing Bevacizumab + Temsirolimus Vs Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Official Title  ICMJEPhase 3b, Randomized, Open-Label Study of Bevacizumab + Temsirolimus ) vs. Bevacizumab + Interferon-Alfa as First-Line Treatment in Subjects With Advanced Renal Cell Carcinoma
Brief Summary

Primary objective: comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Renal Cell Carcinoma
  • Kidney Cancer
  • Urogenital Cancer
Intervention  ICMJE
  • Drug: Bevacizumab + Temsirolimus
  • Drug: Bevacizumab + Interferon-Alfa
Study Arms / Comparison Groups1: Experimental
Experiment (Bevacizumab + Torisel)
Interventions:
  • Drug: Bevacizumab + Temsirolimus
  • Drug: Bevacizumab + Interferon-Alfa

Recruitment Information

Estimated Enrollment  ICMJE800
Estimated Completion DateFebruary 2012
Estimated Primary Completion DateFebruary 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
  • Majority component of conventional clear-cell type is mandatory
  • At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

  • Prior systemic treatment for RCC
  • Evidence of current or prior central nervous system (CNS) metastases
  • Cardiovascular disease
  • Pregnant or nursing women Additional criteria applies
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Trial Managerclintrialparticipation@wyeth.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Croatia,   Czech Republic,   France,   Germany,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00631371
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study ID Numbers  ICMJE3066K1-3311
Study Sponsor  ICMJEWyeth
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorWyeth
Information Provided ByWyeth