Spots Global Cancer Trial Database for PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study
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Trial Identification
Brief Title: PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Study ID: NCT00911170
Study Description
Brief Summary: This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Muscle Shoals, Alabama, United States
Research Site, Jonesboro, Arkansas, United States
Research Site, Anaheim, California, United States
Research Site, Beverly Hills, California, United States
Research Site, Modesto, California, United States
Research Site, San Diego, California, United States
Research Site, Greenwich, Connecticut, United States
Research Site, Dover, Delaware, United States
Research Site, Gainesville, Florida, United States
Research Site, Loxahatchee Groves, Florida, United States
Research Site, Port Saint Lucie, Florida, United States
Research Site, Tamarac, Florida, United States
Research Site, Honolulu, Hawaii, United States
Research Site, Gurnee, Illinois, United States
Research Site, Maywood, Illinois, United States
Research Site, Quincy, Illinois, United States
Research Site, Rockford, Illinois, United States
Research Site, New Albany, Indiana, United States
Research Site, South Bend, Indiana, United States
Research Site, Council Bluffs, Iowa, United States
Research Site, Sioux City, Iowa, United States
Research Site, Waterloo, Iowa, United States
Research Site, Waterloo, Iowa, United States
Research Site, Hutchinson, Kansas, United States
Research Site, Hazard, Kentucky, United States
Research Site, Lexington, Kentucky, United States
Research Site, Paducah, Kentucky, United States
Research Site, Shreveport, Louisiana, United States
Research Site, Bethesda, Maryland, United States
Research Site, Cumberland, Maryland, United States
Research Site, Randallstown, Maryland, United States
Research Site, Towson, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Jefferson City, Missouri, United States
Research Site, Kansas City, Missouri, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Springfield, Missouri, United States
Research Site, Billings, Montana, United States
Research Site, Grand Island, Nebraska, United States
Research Site, Kearney, Nebraska, United States
Research Site, Omaha, Nebraska, United States
Research Site, Portsmouth, New Hampshire, United States
Research Site, Little Silver, New Jersey, United States
Research Site, Somerville, New Jersey, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, Lake Success, New York, United States
Research Site, Nyack, New York, United States
Research Site, Asheville, North Carolina, United States
Research Site, Hickory, North Carolina, United States
Research Site, High Point, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Canton, Ohio, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Massillon, Ohio, United States
Research Site, Middletown, Ohio, United States
Research Site, Lancaster, Pennsylvania, United States
Research Site, Langhorne, Pennsylvania, United States
Research Site, Reading, Pennsylvania, United States
Research Site, Upland, Pennsylvania, United States
Research Site, West Reading, Pennsylvania, United States
Research Site, Willow Grove, Pennsylvania, United States
Research Site, Hilton Head Island, South Carolina, United States
Research Site, Myrtle Beach, South Carolina, United States
Research Site, Nashville, Tennessee, United States
Research Site, Bryan, Texas, United States
Research Site, Corpus Christi, Texas, United States
Research Site, Corpus Christi, Texas, United States
Research Site, Abingdon, Virginia, United States
Research Site, Lynchburg, Virginia, United States
Research Site, Kennewick, Washington, United States
Research Site, Spokane, Washington, United States
Research Site, Hobart, Tasmania, Australia
Research Site, Ballarat, Victoria, Australia
Research Site, Coburg, Victoria, Australia
Research Site, Footscray, Victoria, Australia
Research Site, Frankston, Victoria, Australia
Research Site, Aalst, , Belgium
Research Site, Roeselare, , Belgium
Research Site, Verviers, , Belgium
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Brampton, Ontario, Canada
Research Site, London, Ontario, Canada
Research Site, Sault Ste. Marie, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Laval, Quebec, Canada
Research Site, Levis, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Horovice, , Czechia
Research Site, Nova Ves pod Plesi, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Znojmo, , Czechia
Research Site, Amiens, , France
Research Site, Bordeaux Cedex, , France
Research Site, Cahors Cedex, , France
Research Site, Lille cedex 01, , France
Research Site, Rouen, , France
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Gyor, , Hungary
Research Site, Gyula, , Hungary
Research Site, Kaposvar, , Hungary
Research Site, Kecskemet, , Hungary
Research Site, Szeged, , Hungary
Research Site, Szolnok, , Hungary
Research Site, Cork, , Ireland
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Galway, , Ireland
Research Site, Waterford, , Ireland
Research Site, Benevento, , Italy
Research Site, Palermo, , Italy
Research Site, Roma (RM), , Italy
Research Site, Rozzano (MI), , Italy
Research Site, Taormina (ME), , Italy
Research Site, Daugavpils, , Latvia
Research Site, Riga, , Latvia
Research Site, Riga, , Latvia
Research Site, San Luis Potosi, San Luis P, Mexico
Research Site, Colima, , Mexico
Research Site, Toluca, , Mexico
Research Site, Gdansk, , Poland
Research Site, Lodz, , Poland
Research Site, Olsztyn, , Poland
Research Site, Suwalki, , Poland
Research Site, Warszawa, , Poland
Research Site, Bucharest, , Romania
Research Site, Bucharest, , Romania
Research Site, Cluj Napoca, , Romania
Research Site, Sibiu, , Romania
Research Site, Chelyabinsk, , Russian Federation
Research Site, Kazan, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Samara, , Russian Federation
Research Site, Yaroslavl, , Russian Federation
Research Site, Bratislava, , Slovakia
Research Site, Kosice, , Slovakia
Research Site, Rimavska Sobota, , Slovakia
Research Site, Trnava, , Slovakia
Research Site, Dnipropetrovsk, , Ukraine
Research Site, Donetsk, , Ukraine
Research Site, Ivano-Frankivsk, , Ukraine
Research Site, Kyiv, , Ukraine
Research Site, Lviv, , Ukraine
Research Site, Uzhgorod, , Ukraine
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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