A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell
Both
Carcinoma, Renal Cell
Trial Information
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free Survival (PFS), Core Radiology Assessment
Outcome Time Frame:
Day 28 of each 6-week cycle: duration of treatment phase
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181034
NCT ID:
NCT00083889
Start Date:
August 2004
Completion Date:
September 2008
Related Keywords:
- Carcinoma, Renal Cell
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Kansas City, Kansas 66112 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Farmington, Connecticut 06030-3805 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Milwaukee, Wisconsin 53215 |
| Pfizer Investigational Site | Omaha, Nebraska 68198 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
| Pfizer Investigational Site | Salt Lake City, Utah 84112 |
| Pfizer Investigational Site | Lebanon, New Hampshire 03766 |
