Carcinoma, Renal Cell Clinical Trial
Official title:
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
| Verified date | January 2010 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | September 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | East Melbourne | Victoria |
| Australia | Pfizer Investigational Site | Lismore | New South Wales |
| Australia | Pfizer Investigational Site | Perth | Western Australia |
| Australia | Pfizer Investigational Site | South Brisbane | Queensland |
| Australia | Pfizer Investigational Site | St. Leonards | New South Wales |
| Australia | Pfizer Investigational Site | Victoria | |
| Australia | Pfizer Investigational Site | Woodville South | South Australia |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Brazil | Pfizer Investigational Site | Rio de Janeiro | RJ |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Kelowna | British Columbia |
| Canada | Pfizer Investigational Site | London | Ontario |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Quebec | |
| Canada | Pfizer Investigational Site | Quebec | |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Victoria | British Columbia |
| France | Pfizer Investigational Site | Lyon | |
| France | Pfizer Investigational Site | Paris | Cedex 15 |
| France | Pfizer Investigational Site | Paris Cedex 13 | |
| France | Pfizer Investigational Site | Rennes | |
| France | Pfizer Investigational Site | Saint Herblain | |
| France | Pfizer Investigational Site | Vandoeuvre Les Nancy | |
| Germany | Pfizer Investigational Site | Aachen | |
| Germany | Pfizer Investigational Site | Essen | |
| Germany | Pfizer Investigational Site | Hannover | |
| Germany | Pfizer Investigational Site | Ulm | |
| Germany | Pfizer Investigational Site | Ulm | |
| Italy | Pfizer Investigational Site | Modena | |
| Italy | Pfizer Investigational Site | Napoli | |
| Italy | Pfizer Investigational Site | Pavia | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Poland | Pfizer Investigational Site | Gdansk | |
| Poland | Pfizer Investigational Site | Krakow | |
| Poland | Pfizer Investigational Site | Lodz | |
| Poland | Pfizer Investigational Site | Lublin | |
| Poland | Pfizer Investigational Site | Moczowego | Warszawa |
| Poland | Pfizer Investigational Site | Poznan | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Russian Federation | Pfizer Investigational Site | Chelyabinsk | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Obninsk | Kaluga Region |
| Russian Federation | Pfizer Investigational Site | Saint-Petersburg | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Russian Federation | Pfizer Investigational Site | Tomsk | |
| Spain | Pfizer Investigational Site | Hospitalet de Llobregat | Barcelona |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Pamplona | Navarra |
| Spain | Pfizer Investigational Site | Sevilla | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Manchester | Lancashire |
| United Kingdom | Pfizer Investigational Site | Northwood | Middlesex |
| United Kingdom | Pfizer Investigational Site | Sutton Surrey | |
| United Kingdom | Pfizer Investigational Site | Whitchurch | Cardiff |
| United States | Pfizer Investigational Site | Aurora | Colorado |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Bronx | New York |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Columbus | Mississippi |
| United States | Pfizer Investigational Site | Corinth | Mississippi |
| United States | Pfizer Investigational Site | Covington | Louisiana |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Detoit | Michigan |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Farmington Hills | Michigan |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Jonesboro | Arkansas |
| United States | Pfizer Investigational Site | Kansas City | Kansas |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Lebanon | New Hampshire |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Madison | Wisconsin |
| United States | Pfizer Investigational Site | Maywood | Illinois |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Southaven | Mississippi |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tupelo | Mississippi |
| United States | Pfizer Investigational Site | Tyler | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Brazil, Canada, France, Germany, Italy, Poland, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS), Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | No | |
| Primary | Progression-Free Survival (PFS), Investigator's Assessment | Day 28 of each 6-week cycle: duration of treatment phase | No | |
| Secondary | Objective Response, Core Radiology Assessment | Day 28 of each 6-week cycle: duration of treatment phase | No | |
| Secondary | Objective Response, Investigator's Assessment | Day 28 of each 6-week cycle: duration of treatment phase | No | |
| Secondary | Overall Survival (OS) | Clinic visit or telephone contact every 2 months until death | No | |
| Secondary | Time to Tumor Progression (TTP), Core Radiology Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | No | |
| Secondary | Time to Tumor Progression (TTP), Investigator's Assessment | Randomization to first documentation of tumor progression: duration of treatment phase | No | |
| Secondary | Duration of Response (DR), Core Radiology Assessement | Day 28 of each cycle: duraton of treatment phase | No | |
| Secondary | Duration of Response (DR), Investigator's Assessment | Day 28 of each cycle: duration of treatment phase | No | |
| Secondary | FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | FACT-Kidney Symptom Index (FKSI) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | Functional Assessment of Cancer Therapy-General (FACT-G) | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | EuroQoL Five Dimension (EQ-5D) Health State Index | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | Euro-QoL Visual Analog Scale (EQ-VAS) | Day 1 & 28 of each cycle: duration of treatment phase | No | |
| Secondary | 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 | Day 1 & Day 28, Cycle 1 to Cycle 4 | No | |
| Secondary | Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis | Day 1 & Day 28, Cycle 1 to Cycle 4 | No | |
| Secondary | Incremental Cost Effectiveness Ratio (ICER) | post study measurement | No | |
| Secondary | Ctrough Concentrations of SU011248 | Day 28 of Cycle 1 to Cycle 4 | No | |
| Secondary | Ctrough Concentrations of Metabolite SU012662 | Day 28 of Cycle 1 to Cycle 4 | No | |
| Secondary | Ctrough Concentrations of SU011248 and Active Metabolite SU012662 | Day 28 of Cycle 1 to Cycle 4 | No |
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