547
Participants
Start Date
February 28, 2003
Primary Completion Date
October 31, 2008
Study Completion Date
October 31, 2008
Modified Bolus 5-FU/LV with Irinotecan
Day 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID \[two times a day\] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
FOLFIRI + bevacizumab
"Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.~I m m e d i a t e l y f o l l o w e d b y :~5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks~Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.~I m m e d i a t e l y f o l l o w e d b y :~5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID \[two times a day\] oral Every 2 weeks"
miFL + bevacizumab
Day 1 Bevacizumab 7.5mg/kg IV \*over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID \[two times a day\] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID \[two times a day\] continues daily without interruption Every 3 weeks
Infusional 5-FU/LV with Irinotecan
Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID \[two times a day\](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Oral Capecitabine with Irinotecan
Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID \[two times a day\] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Pfizer Investigational Site, Auckland
Pfizer Investigational Site, Waratah
Pfizer Investigational Site, Clayton
Pfizer Investigational Site, Frankston
Pfizer Investigational Site, South Brisbane
Pfizer Investigational Site, Woodville
Pfizer Investigational Site, Bedford Park
Pfizer Investigational Site, Wellington
Pfizer Investigational Site, Riccarton
Pfizer Investigational Site, Dunedin
Pfizer Investigational Site, Manhaset
Pfizer Investigational Site, Rockville Centre
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Pfizer Investigational Site, Philadelphia
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Pfizer Investigational Site, Washington D.C.
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Pfizer Investigational Site, Winston-Salem
Pfizer Investigational Site, Winston-Salem
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Pfizer Investigational Site, Hollywood
Pfizer Investigational Site, Miami
Pfizer Investigational Site, Lauderhill
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Pfizer Investigational Site, Birmingham
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Pfizer Investigational Site, Mobile
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Pfizer Investigational Site, Collierville
Pfizer Investigational Site, Germantown
Pfizer Investigational Site, Jackson
Pfizer Investigational Site, Columbus
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Pfizer Investigational Site, Norman
Pfizer Investigational Site, Oklahoma City
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Pfizer Investigational Site, Dallas
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Pfizer Investigational Site, Longview
Pfizer Investigational Site, Tyler
Pfizer Investigational Site, Arlington
Pfizer Investigational Site, Bedford
Pfizer Investigational Site, Fort Worth
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Pfizer Investigational Site, Wichita Falls
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Pfizer Investigational Site, Houston
Pfizer Investigational Site, Houston
Pfizer Investigational Site, Webster
Pfizer Investigational Site, New Braunfels
Pfizer Investigational Site, McAllen
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Pfizer Investigational Site, Austin
Pfizer Investigational Site, Midland
Pfizer Investigational Site, Odessa
Pfizer Investigational Site, El Paso
Pfizer Investigational Site, El Paso
Pfizer Investigational Site, Boulder
Pfizer Investigational Site, Tucson
Pfizer Investigational Site, Flagstaff
Pfizer Investigational Site, Sedona
Pfizer Investigational Site, Albuquerque
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Pfizer Investigational Site, Santa Fe
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Pfizer Investigational Site, Mission Hills
Pfizer Investigational Site, San Diego
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Pfizer Investigational Site, Orange
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Pfizer Investigational Site, Yakima
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Pfizer Investigational Site, Miami Beach
Pfizer Investigational Site, Québec
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Pfizer Investigational Site, Bangor
Pfizer Investigational Site, Boston
Pfizer Investigational Site, Boston
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Pfizer Investigational Site, Burlington
Pfizer Investigational Site, Pittsfield
Pfizer Investigational Site, Hooksett
Pfizer Investigational Site, Lebanon
Pfizer Investigational Site, Nashua
Pfizer Investigational Site, Summit
Pfizer Investigational Site, Fayetteville
Pfizer Investigational Site, Philadelphia
Pfizer Investigational Site, Abilene
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Pfizer Investigational Site, Dallas
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Pfizer Investigational Site, Sherman
Pfizer Investigational Site, Tyler
Pfizer Investigational Site, Colchester
Pfizer Investigational Site, Moncton
Pfizer Investigational Site, St. John's
Pfizer Investigational Site, Halifax
Pfizer Investigational Site, Sydney
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Pfizer Investigational Site, Kitchener
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Pfizer Investigational Site, Scarborough Village
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Pfizer Investigational Site, Chicoutimi
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Pfizer Investigational Site, Laval
Pfizer Investigational Site, Montreal
Pfizer Investigational Site, Montreal
Pfizer Investigational Site, Montreal
Pfizer Investigational Site, Rimouski
Pfizer Investigational Site, Regina
Pfizer Investigational Site, Saskatoon
Lead Sponsor
Pfizer
INDUSTRY