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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

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Interferon-alfa Drug: SU011248 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Progression-Free Survival (PFS), Core Radiology Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]
  2. Progression-Free Survival (PFS), Investigator's Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]

Secondary Outcome Measures :
  1. Objective Response, Core Radiology Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]
  2. Objective Response, Investigator's Assessment [ Time Frame: Day 28 of each 6-week cycle: duration of treatment phase ]
  3. Overall Survival (OS) [ Time Frame: Clinic visit or telephone contact every 2 months until death ]
  4. Time to Tumor Progression (TTP), Core Radiology Assessment [ Time Frame: Randomization to first documentation of tumor progression: duration of treatment phase ]
  5. Time to Tumor Progression (TTP), Investigator's Assessment [ Time Frame: Randomization to first documentation of tumor progression: duration of treatment phase ]
  6. Duration of Response (DR), Core Radiology Assessement [ Time Frame: Day 28 of each cycle: duraton of treatment phase ]
  7. Duration of Response (DR), Investigator's Assessment [ Time Frame: Day 28 of each cycle: duration of treatment phase ]
  8. FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  9. FACT-Kidney Symptom Index (FKSI) Subscale [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  10. Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. EuroQoL Five Dimension (EQ-5D) Health State Index [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  16. Euro-QoL Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 & 28 of each cycle: duration of treatment phase ]
  17. 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 ]
  18. 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 ]
  19. Incremental Cost Effectiveness Ratio (ICER) [ Time Frame: post study measurement ]
  20. Ctrough Concentrations of SU011248 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ]
  21. Ctrough Concentrations of Metabolite SU012662 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ]
  22. Ctrough Concentrations of SU011248 and Active Metabolite SU012662 [ Time Frame: Day 28 of Cycle 1 to Cycle 4 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083889


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

Additional Information:
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
First Posted: June 4, 2004    Key Record Dates
Results First Posted: December 10, 2009
Last Update Posted: January 26, 2010
Last Verified: January 2010

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