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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00083889
First received: June 3, 2004
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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).


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Interferon-alfa
Drug: SU011248
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS), Core Radiology Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS), Investigator's Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response, Core Radiology Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • Objective Response, Investigator's Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Clinic visit or telephone contact every 2 months until death ] [ Designated as safety issue: No ]
  • Time to Tumor Progression (TTP), Core Radiology Assessment [ Time Frame: Randomization to first documentation of tumor progression: duration of treatment phase ] [ Designated as safety issue: No ]
  • Time to Tumor Progression (TTP), Investigator's Assessment [ Time Frame: Randomization to first documentation of tumor progression: duration of treatment phase ] [ Designated as safety issue: No ]
  • Duration of Response (DR), Core Radiology Assessement [ Time Frame: Day 28 of each cycle: duraton of treatment phase ] [ Designated as safety issue: No ]
  • Duration of Response (DR), Investigator's Assessment [ Time Frame: Day 28 of each cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • FACT-Kidney Symptom Index (FKSI) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • EuroQoL Five Dimension (EQ-5D) Health State Index [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • Euro-QoL Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incremental Cost Effectiveness Ratio (ICER) [ Time Frame: post study measurement ] [ Designated as safety issue: No ]
  • Ctrough Concentrations of SU011248 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ] [ Designated as safety issue: No ]
  • Ctrough Concentrations of Metabolite SU012662 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ] [ Designated as safety issue: No ]
  • Ctrough Concentrations of SU011248 and Active Metabolite SU012662 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ] [ Designated as safety issue: No ]

Enrollment: 750
Study Start Date: August 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 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
Experimental: 1 Drug: SU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Other Name: Sunitinib, SUTENT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083889

  Show 124 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00083889     History of Changes
Obsolete Identifiers: NCT00098657
Other Study ID Numbers: A6181034
Study First Received: June 3, 2004
Results First Received: September 16, 2009
Last Updated: January 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Interferon-alpha
Interferons
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014