Clinical trial NCT00063141: Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
Official title: Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2003-06-25
Enrollment: 1302
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: The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.


Eligibility criteria: Inclusion Criteria:

* Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry \[IHC\] (may be based on archival samples) and is metastatic.
* Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
* Prior fluoropyrimidine-containing regimen (5-fluorouracil \[5-FU\], capecitabine, or uracil/tegafur \[UFT\]), for the first-line treatment of metastatic disease.

Exclusion Criteria:

* A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy
* Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
* Known or documented brain metastases

Primary outcomes:
measure: Overall Survival
timeFrame: Every 3 months after subject off-treatment
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Q6 Weeks
measure: Response
timeFrame: Q6 Weeks
measure: Duration of Response
timeFrame: Q6 Weeks
measure: Time to Response
timeFrame: Q6 Weeks
measure: Disease Control Rate
timeFrame: Q6 Weeks
measure: Safety
timeFrame: Q3 Weeks
measure: Quality of Life
timeFrame: Q6 Weeks
measure: Health Economics
timeFrame: Q3 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: ImClone Investigational Site
state: Arizona
city: Pine Bluff
country: United States
facility: ImClone Investigational Site
state: Arkansas
city: Bakersfield
country: United States
facility: ImClone Investigational Site
state: California
city: Berkeley
country: United States
facility: ImClone Investigational Site
state: California
city: Beverly Hills
country: United States
facility: ImClone Investigational Site
state: California
city: Corona
country: United States
facility: ImClone Investigational Site
state: California
city: Gilroy
country: United States
facility: ImClone Investigational Site
state: California
city: Greenbrae
country: United States
facility: ImClone Investigational Site
state: California
city: Long Beach
country: United States
facility: ImClone Investigational Site
state: California
city: Los Angeles
country: United States
facility: ImClone Investigational Site
state: California
city: Los Angeles
country: United States
facility: ImClone Investigational Site
state: California
city: Montebello
country: United States
facility: ImClone Investigational Site
state: California
city: Orange
country: United States
facility: ImClone Investigational Site
state: California
city: Palm Springs
country: United States
facility: ImClone Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: ImClone Investigational Site
state: California
city: San Diego
country: United States
facility: ImClone Investigational Site
state: California
city: Stockton
country: United States
facility: ImClone Investigational Site
state: California
city: Vallejo
country: United States
facility: ImClone Investigational Site
state: California
city: Aurora
country: United States
facility: ImClone Investigational Site
state: Colorado
city: Denver
country: United States
facility: ImClone Investigational Site
state: Colorado
city: New Haven
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: New London
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Norwich
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: ImClone Investigational Site
state: Connecticut
city: Fort Myers
country: United States
facility: ImClone Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: ImClone Investigational Site
state: Florida
city: Inverness
country: United States
facility: ImClone Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: ImClone Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: ImClone Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: ImClone Investigational Site
state: Florida
city: Lakeland
country: United States
facility: ImClone Investigational Site
state: Florida
city: Miami
country: United States
facility: ImClone Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: ImClone Investigational Site
state: Florida
city: Orlando
country: United States
facility: ImClone Investigational Site
state: Florida
city: Port St. Lucie
country: United States
facility: ImClone Investigational Site
state: Florida
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Columbus
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Macon
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Savannah
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Tucker
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: ImClone Investigational Site
state: Hawaii
city: Naperville
country: United States
facility: ImClone Investigational Site
state: Illinois
city: South Bend
country: United States
facility: ImClone Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: ImClone Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: ImClone Investigational Site
state: Kansas
city: Lexington
country: United States
facility: ImClone Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: ImClone Investigational Site
state: Kentucky
city: Richmond
country: United States
facility: ImClone Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: ImClone Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: ImClone Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: ImClone Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: ImClone Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: ImClone Investigational Site
state: Maryland
city: Frederick
country: United States
facility: ImClone Investigational Site
state: Maryland
city: Boston
country: United States
facility: ImClone Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: ImClone Investigational Site
state: Michigan
city: Detroit
country: United States
facility: ImClone Investigational Site
state: Michigan
city: Southfield
country: United States
facility: ImClone Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: ImClone Investigational Site
state: Minnesota
city: Robbinsdale
country: United States
facility: ImClone Investigational Site
state: Minnesota
city: St. Louis Park
country: United States
facility: ImClone Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: ImClone Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: ImClone Investigational Site
state: Missouri
city: Rolla
country: United States
facility: ImClone Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: ImClone Investigational Site
state: Missouri
city: Trenton
country: United States
facility: ImClone Investigational Site
state: New Jersey
city: Voorhees
country: United States
facility: ImClone Investigational Site
state: New Jersey
city: Albany
country: United States
facility: ImClone Investigational Site
state: New York
city: Bronx
country: United States
facility: ImClone Investigational Site
state: New York
city: East Setauket
country: United States
facility: ImClone Investigational Site
state: New York
city: Latham
country: United States
facility: ImClone Investigational Site
state: New York
city: Mineola
country: United States
facility: ImClone Investigational Site
state: New York
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: Rexford
country: United States
facility: ImClone Investigational Site
state: New York
city: Stony Brook
country: United States
facility: ImClone Investigational Site
state: New York
city: Valhalla
country: United States
facility: ImClone Investigational Site
state: New York
city: Durham
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: High Point
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: ImClone Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: ImClone Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: ImClone Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: ImClone Investigational Site
state: Ohio
city: Columbus
country: United States
facility: ImClone Investigational Site
state: Ohio
city: Dayton
country: United States
facility: ImClone Investigational Site
state: Ohio
city: Newark
country: United States
facility: ImClone Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: ImClone Investigational Site
state: Oklahoma
city: Hershey
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: ImClone Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: ImClone Investigational Site
state: Tennessee
city: Austin
country: United States
facility: ImClone Investigational Site
state: Texas
city: Dallas
country: United States
facility: ImClone Investigational Site
state: Texas
city: Houston
country: United States
facility: ImClone Investigational Site
state: Texas
city: Plano
country: United States
facility: ImClone Investigational Site
state: Texas
city: Temple
country: United States
facility: ImClone Investigational Site
state: Texas
city: Ogden
country: United States
facility: ImClone Investigational Site
state: Utah
city: Arlington
country: United States
facility: ImClone Investigational Site
state: Virginia
city: Danville
country: United States
facility: ImClone Investigational Site
state: Virginia
city: Newport News
country: United States
facility: ImClone Investigational Site
state: Virginia
city: Richmond
country: United States
facility: ImClone Investigational Site
state: Virginia
city: Seattle
country: United States
facility: ImClone Investigational Site
state: Washington
city: Spokane
country: United States
facility: ImClone Investigational Site
state: Washington
city: Spokane
country: United States
facility: ImClone Investigational Site
state: Washington
city: Walla Walla
country: United States
facility: ImClone Investigational Site
state: Washington
city: Green Bay
country: United States
facility: ImClone Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: ImClone Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: ImClone Investigational Site
state: Wisconsin
city: Perth
country: Australia
facility: ImClone Investigational Site
state: Australian Capital Territory
city: Sydney
country: Australia
facility: ImClone Investigational Site
state: Australian Capital Territory
city: Sydney
country: Australia
facility: ImClone Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: ImClone Investigational Site
state: New South Wales
city: South Brisbane
country: Australia
facility: ImClone Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: ImClone Investigational Site
state: South Australia
city: Wien
country: Australia
facility: ImClone Investigational Site
city: Graz
country: Austria
facility: ImClone Investigational Site
city: Salzburg
country: Austria
facility: ImClone Investigational Site
city: Wein
country: Austria
facility: ImClone Investigational Site
city: Wien
country: Austria
facility: ImClone Investigational Site
city: Charleroi
country: Belgium
facility: ImClone Investigational Site
city: Brno
country: Czech Republic
facility: ImClone Investigational Site
city: Olomouc
country: Czech Republic
facility: ImClone Investigational Site
city: Praha 5
country: Czech Republic
facility: ImClone Investigational Site
city: Helsinki
country: Finland
facility: ImClone Investigational Site
city: Avignon
country: France
facility: ImClone Investigational Site
city: Marseille
country: France
facility: ImClone Investigational Site
city: Nice
country: France
facility: ImClone Investigational Site
city: Saint Herblain
country: France
facility: ImClone Investigational Site
city: Aschaffenburg
country: Germany
facility: ImClone Investigational Site
city: Augsburg
country: Germany
facility: ImClone Investigational Site
city: Dessau
country: Germany
facility: ImClone Investigational Site
city: Dortmund
country: Germany
facility: ImClone Investigational Site
city: Essen
country: Germany
facility: ImClone Investigational Site
city: Hamburg
country: Germany
facility: ImClone Investigational Site
city: Hanburg
country: Germany
facility: ImClone Investigational Site
city: Kaiserslautern
country: Germany
facility: ImClone Investigational Site
city: Kassel
country: Germany
facility: ImClone Investigational Site
city: Magdeburg
country: Germany
facility: ImClone Investigational Site
city: Mainz
country: Germany
facility: ImClone Investigational Site
city: Mannheim
country: Germany
facility: ImClone Investigational Site
city: Muchnhen
country: Germany
facility: ImClone Investigational Site
city: Munchen
country: Germany
facility: ImClone Investigational Site
city: Regensburg
country: Germany
facility: ImClone Investigational Site
city: Saarbrucken
country: Germany
facility: ImClone Investigational Site
city: Stralsund
country: Germany
facility: ImClone Investigational Site
city: Stuttgart
country: Germany
facility: ImClone Investigational Site
city: Hong Kong
country: Hong Kong
facility: ImClone Investigational Site
city: Rozzano
country: Italy
facility: ImClone Investigational Site
state: Milano
city: Ancona
country: Italy
facility: ImClone Investigational Site
city: Bergamo
country: Italy
facility: ImClone Investigational Site
city: Candiolo
country: Italy
facility: ImClone Investigational Site
city: Firenze
country: Italy
facility: ImClone Investigational Site
city: Genova
country: Italy
facility: ImClone Investigational Site
city: Livomo
country: Italy
facility: ImClone Investigational Site
city: Milano
country: Italy
facility: ImClone Investigational Site
city: Modena
country: Italy
facility: ImClone Investigational Site
city: Napoli
country: Italy
facility: ImClone Investigational Site
city: Perugia
country: Italy
facility: ImClone Investigational Site
city: Reggio Emilia
country: Italy
facility: ImClone Investigational Site
city: Roma
country: Italy
facility: ImClone Investigational Site
city: Rome
country: Italy
facility: ImClone Investigational Site
city: Apeldorn
country: Netherlands
facility: ImClone Investigational Site
city: Dordrecht
country: Netherlands
facility: ImClone Investigational Site
city: Montebello
country: Norway
facility: ImClone Investigational Site
state: Oslo
city: Oslo
country: Norway
facility: ImClone Investigational Site
city: Porto
country: Portugal
facility: ImClone Investigational Site
city: Bratislava
country: Slovakia
facility: ImClone Investigational Site
city: Lund
country: Sweden
facility: ImClone Investigational Site
city: Stockholm
country: Sweden
facility: ImClone Investigational Site
city: Bern
country: Switzerland
facility: ImClone Investigational Site
city: Liestal
country: Switzerland
facility: ImClone Investigational Site
city: Zurich
country: Switzerland
facility: ImClone Investigational Site
city: Foresterhill
country: United Kingdom
facility: ImClone Investigational Site
state: Aberdeenshire
city: Hull
country: United Kingdom
facility: ImClone Investigational Site
state: Avon
city: Glasgow
country: United Kingdom
facility: ImClone Investigational Site
state: Central
city: Poole
country: United Kingdom
facility: ImClone Investigational Site
state: Dorset
city: London
country: United Kingdom
facility: ImClone Investigational Site
state: Greater London
city: Bournemouth
country: United Kingdom
facility: ImClone Investigational Site
state: Hampshire
city: Guildford
country: United Kingdom
facility: ImClone Investigational Site
state: Surrey
city: Sutton
country: United Kingdom
facility: ImClone Investigational Site
state: Surrey
Study officials:
affiliation: Eli Lilly and Company
name: E-mail: ClinicalTrials@ ImClone.com
role: STUDY_CHAIR
References: