217
Participants
Start Date
January 31, 2006
Primary Completion Date
May 31, 2010
Study Completion Date
June 30, 2011
SU011248
SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
Chemotherapy
"The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.~1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks~2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles~3. Docetaxel - 75-100 mg/m2 every 3 weeks~4. Paclitaxel - 175-200 mg/m2 every 3 weeks~5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.~6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248."
Pfizer Investigational Site, Budapest
Pfizer Investigational Site, Budapest
Pfizer Investigational Site, Sofia
Pfizer Investigational Site, Sofia
Pfizer Investigational Site, Sofia
Pfizer Investigational Site, Stara Zagora
Pfizer Investigational Site, Varna
Pfizer Investigational Site, Berlin
Pfizer Investigational Site, The Bronx
Pfizer Investigational Site, The Bronx
Pfizer Investigational Site, Wexford
Pfizer Investigational Site, Pittsburgh
Pfizer Investigational Site, Greensburg
Pfizer Investigational Site, Girona
Pfizer Investigational Site, Washington D.C.
Pfizer Investigational Site, Milan
Pfizer Investigational Site, Besançon
Pfizer Investigational Site, Besançon
Pfizer Investigational Site, Lleida
Pfizer Investigational Site, Goldsboro
Pfizer Investigational Site, Wilson
Pfizer Investigational Site, Clinton
Pfizer Investigational Site, Málaga
Pfizer Investigational Site, Decatur
Pfizer Investigational Site, Marietta
Pfizer Investigational Site, Tucker
Pfizer Investigational Site, Atlanta
Pfizer Investigational Site, Atlanta
Pfizer Investigational Site, Macon
Pfizer Investigational Site, Aviano (PN)
Pfizer Investigational Site, Boca Raton
Pfizer Investigational Site, Istanbul
Pfizer Investigational Site, Memphis
Pfizer Investigational Site, Memphis
Pfizer Investigational Site, Memphis
Pfizer Investigational Site, Biloxi
Pfizer Investigational Site, Seville
Pfizer Investigational Site, Nantes
Pfizer Investigational Site, Indianapolis
Pfizer Investigational Site, Dearborn
Pfizer Investigational Site, Brownstown
Pfizer Investigational Site, Detroit
Pfizer Investigational Site, Bloomfield Hills
Pfizer Investigational Site, West Bloomfield
Pfizer Investigational Site, Dnipropetrovsk
Pfizer Investigational Site, Prato, FI
Pfizer Investigational Site, Zion
Pfizer Investigational Site, Clarkson Valley
Pfizer Investigational Site, St Louis
Pfizer Investigational Site, St Louis
Pfizer Investigational Site, Odesa
Pfizer Investigational Site, Del City
Pfizer Investigational Site, Plano
Pfizer Investigational Site, Richardson
Pfizer Investigational Site, Plano
Pfizer Investigational Site, Dallas
Pfizer Investigational Site, Tyler
Pfizer Investigational Site, Paris
Pfizer Investigational Site, Fort Worth
Pfizer Investigational Site, Houston
Pfizer Investigational Site, Houston
Pfizer Investigational Site, San Antonio
Pfizer Investigational Site, San Antonio
Pfizer Investigational Site, San Antonio
Pfizer Investigational Site, San Atonio
Pfizer Investigational Site, San Antonio
Pfizer Investigational Site, Aurora
Pfizer Investigational Site, Los Angeles
Pfizer Investigational Site, Santa Monica
Pfizer Investigational Site, Pasadena
Pfizer Investigational Site, Northridge
Pfizer Investigational Site, Mission Hills
Pfizer Investigational Site, Valencia
Pfizer Investigational Site, Rancho Cucamonga
Pfizer Investigational Site, Glendora
Pfizer Investigational Site, Pomona
Pfizer Investigational Site, West Covina
Pfizer Investigational Site, Fullerton
Pfizer Investigational Site, Corona
Pfizer Investigational Site, Federal Way
Pfizer Investigational Site, Seattle
Pfizer Investigational Site, Seattle
Pfizer Investigational Site, Puyallup
Pfizer Investigational Site, Tacoma
Pfizer Investigational Site, Lakewood
Pfizer Investigational Site, Los Angeles
Pfizer Investigational Site, Los Angeles
Pfizer Investigational Site, Palm Springs
Pfizer Investigational Site, Gainesville
Pfizer Investigational Site, Midland Park
Pfizer Investigational Site, Morristown
Pfizer Investigational Site, Paramus
Pfizer Investigational Site, Pompton Plains
Pfizer Investigational Site, Ridgewood
Pfizer Investigational Site, Summit
Pfizer Investigational Site, Westwood
Pfizer Investigational Site, Hershey
Pfizer Investigational Site, Pittsburgh
Pfizer Investigational Site, Dallas
Pfizer Investigational Site, Edmonton
Pfizer Investigational Site, Toronto
Pfizer Investigational Site, Brno
Pfizer Investigational Site, Brno
Pfizer Investigational Site, Prague
Pfizer Investigational Site, Prague
Pfizer Investigational Site, Barcelona
Pfizer Investigational Site, Adana
Pfizer Investigational Site, Ankara
Pfizer Investigational Site, Ankara
Pfizer Investigational Site, Kyiv
Pfizer Investigational Site, Edinburgh
Pfizer Investigational Site, Oxfordshire
Pfizer Investigational Site, Southampton
Lead Sponsor
Pfizer
INDUSTRY