Clinical trial NCT00111020: Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Official title: Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Renal Cell
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-05-17
Enrollment: 2567
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced (unresectable, recurrent or metastatic) RCC
* Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
* Patients with an ECOG performance status of 0-2
* Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
* Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice

Exclusion Criteria:

* Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
* Patients who have participated in any other sorafenib trial
* Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
* Life expectancy of less than two months
* Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
* Patients with active coronary artery disease or ischemia
* Patients with Child-Pugh class C hepatic impairment
* Patients with severe renal impairment or who require dialysis
* Patients with active uncontrolled hypertension
* Patients with recent or active bleeding diathesis

Primary outcomes:
measure: Safety parameters
timeFrame: From signing consent to 30 days after last dose of study drug
Secondary outcomes:
measure: Limited radiological evaluations
timeFrame: At baseline, than every 8 weeks after start of sorafenib
Other outcomes:
Locations:
city: Bessemer
country: United States
state: Alabama
city: Cullman
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Glendale
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Conway
country: United States
state: Arkansas
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Pine Bluff
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Beverly
country: United States
state: California
city: Concord
country: United States
state: California
city: Duarte
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Glendale
country: United States
state: California
city: Highland
country: United States
state: California
city: La Jolla
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
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city: Los Angeles
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city: Charleston
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city: Florence
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city: Clarksville
country: United States
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city: Memphis
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city: Memphis
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city: Nashville
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state: Tennessee
city: Amarillo
country: United States
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city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Bennington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Lynchburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Lacey
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Yakima
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
city: Huntington
country: United States
state: West Virginia
city: Morgantown
country: United States
state: West Virginia
city: Glendale
country: United States
state: Wisconsin
city: Green Bay
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
city: Marshfield
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Wausau
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Stadler WM, Figlin RA, McDermott DF, Dutcher JP, Knox JJ, Miller WH Jr, Hainsworth JD, Henderson CA, George JR, Hajdenberg J, Kindwall-Keller TL, Ernstoff MS, Drabkin HA, Curti BD, Chu L, Ryan CW, Hotte SJ, Xia C, Cupit L, Bukowski RM; ARCCS Study Investigators. Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer. 2010 Mar 1;116(5):1272-80. doi: 10.1002/cncr.24864.