Clinical trial NCT00101686: Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.
Official title: A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-01-13
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] with infusional 5-fluorouracil (5-FU)\] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease)
* Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
* An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
* The primary cancer was a Duke's A or B1.
* Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.

Exclusion Criteria:

* Patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
* Patients cannot have concurrent malignancies at study entry.
* Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.

Primary outcomes:
measure: Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
timeFrame: every 6 weeks until disease progression
Secondary outcomes:
measure: Time to Progression: FOLFIRI, mIFL and CapeIRI
timeFrame: every 6 weeks until disease progression
measure: Overall Response: FOLFIRI, mIFL and CapeIRI
timeFrame: every 6 weeks during chemotherapy until disease progression
measure: Survival Time: FOLFIRI, mIFL and CapeIRI
timeFrame: assessed at least every week during treatment and at least every 3 months during follow-up
measure: 1 Year Survival: FOLFIRI, mIFL and CapeIRI
timeFrame: 1 year from date of randomization
measure: Time to Progression : Celecoxib and Placebo
timeFrame: every 6 weeks until disease progression
measure: Overall Response: Celecoxib and Placebo
timeFrame: every 6 weeks during chemotherapy until disease progression
measure: Survival Time: Celecoxib and Placebo
timeFrame: assessed at least every week during treatment and at least every 3 months during follow-up
measure: Time to Progression: Bevacizumab With FOLFIRI, mIFL
timeFrame: every 6 weeks until disease progression
measure: Overall Response: Bevacizumab With FOLFIRI, mIFL
timeFrame: every 6 weeks during chemotherapy until disease progression
measure: 1 Year Survival: Bevacizumab With FOLFIRI, mIFL
timeFrame: 1 year from date of randomization
measure: Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL
timeFrame: Last Follow-Up Visit
measure: Dose Reduction Due to Treatment Emergent Adverse Events
timeFrame: Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI
measure: Overall Relative Dose Intensity of Irinotecan
timeFrame: End of treatment cycle
Other outcomes:
Locations:
city: Birmgingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmngham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Flagstaff
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sedona
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Hot Spring
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Springdale
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Arroyo Grande
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountian Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Gatos
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Modesto
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Oxnard
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Jose
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Norwalk
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tamarac
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Niles
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Fishers
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Alexandria
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shrevport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Bangor
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Annapolis
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Pittsfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Burnsville
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Robbinsdale
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Joplin
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Hooksett
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Nashua
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Summit
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Santa Fe
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Manhaset
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rockville Centre
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hendersonville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bartlesville
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Abington
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Collierville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Abilene
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bedford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Denton
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fredericksburg
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Garland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lewisville
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: McAllen
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mesquite
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Midland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Odessa
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Paris
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Sherman
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Waco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Webster
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Colchester
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Fairfax
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Newport News
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Edmonds
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Lacy
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Yakima
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Waratah
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: South Brisbane
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Frankston
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Moncton
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: St. Johns
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Sydney
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Fleurimont
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Rimouski
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Auckland
country: New Zealand
facility: Pfizer Investigational Site
city: Dunedin
country: New Zealand
facility: Pfizer Investigational Site
city: Riccarton
country: New Zealand
facility: Pfizer Investigational Site
city: Wellington
country: New Zealand
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: