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SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00083889
Recruitment Status : Completed
First Posted : June 4, 2004
Results First Posted : December 10, 2009
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 3, 2004
First Posted Date  ICMJE June 4, 2004
Results First Submitted Date September 16, 2009
Results First Posted Date December 10, 2009
Last Update Posted Date January 26, 2010
Study Start Date  ICMJE August 2004
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
  • Progression-Free Survival (PFS), Core Radiology Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]
  • Progression-Free Survival (PFS), Investigator's Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00083889 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
  • Objective Response, Core Radiology Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]
  • Objective Response, Investigator's Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]
  • Overall Survival (OS) [ Time Frame: Clinic visit or telephone contact every 2 months until death ]
  • Time to Tumor Progression (TTP), Core Radiology Assessment [ Time Frame: Randomization to first documentation of tumor progression: duration of treatment phase ]
  • Time to Tumor Progression (TTP), Investigator's Assessment [ Time Frame: Randomization to first documentation of tumor progression: duration of treatment phase ]
  • Duration of Response (DR), Core Radiology Assessement [ Time Frame: Day 28 of each cycle: duraton of treatment phase ]
  • Duration of Response (DR), Investigator's Assessment [ Time Frame: Day 28 of each cycle: duration of treatment phase ]
  • FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • FACT-Kidney Symptom Index (FKSI) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • EuroQoL Five Dimension (EQ-5D) Health State Index [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • Euro-QoL Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  • Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis [ Time Frame: Day 1 & Day 28, Cycle 1 to Cycle 4 ]
  • Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis [ Time Frame: Day 1 & Day 28, Cycle 1 to Cycle 4 ]
  • Incremental Cost Effectiveness Ratio (ICER) [ Time Frame: post study measurement ]
  • Ctrough Concentrations of SU011248 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ]
  • Ctrough Concentrations of Metabolite SU012662 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ]
  • Ctrough Concentrations of SU011248 and Active Metabolite SU012662 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Official Title  ICMJE A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Brief Summary The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE
  • Drug: Interferon-alfa
    3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
    Other Name: Roferon
  • Drug: SU011248
    50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
    Other Name: Sunitinib, SUTENT
Study Arms
  • Active Comparator: 2
    Intervention: Drug: Interferon-alfa
  • Experimental: 1
    Intervention: Drug: SU011248
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: November 6, 2009)
750
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed renal cell carcinoma of clear cell histology with metastases
  • Evidence of measurable disease by radiographic technique
  • Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

Exclusion Criteria:

  • Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
  • History of or known brain metastases
  • Serious acute or chronic illness or recent history of significant cardiac abnormality
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   France,   Germany,   Italy,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00083889
Other Study ID Numbers  ICMJE A6181034
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010

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