Clinical trial NCT00615056: A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
Official title: A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 171
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 study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.


Eligibility criteria: Inclusion Criteria:

* Histologically documented colorectal cancer plus one of the following:
* Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
* Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.

Exclusion Criteria:

* Prior treatment in first line metastatic setting with more than one regimen
* Prior irradiation of more than 25% of bone marrow.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline until death or up to 1 year after the randomization of last participant
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks
measure: Duration of Response (DR)
timeFrame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks
measure: Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal
timeFrame: Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal
measure: Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal
timeFrame: Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Antioch
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Pleasant Hill
country: United States
facility: Pfizer Investigational Site
state: California
city: San Leandro
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Bonita Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Cape Coral
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Cape Coral
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Venice
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Venice
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Ringgold
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Paducah
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Paducah
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: New Albany
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Fairfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Hamilton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Chattanooga
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Gallatin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hixson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Paris
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Union City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mechanicsville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Midlothian
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Levis
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Lille
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Kashiwa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Suntougun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Jeollanam-do
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: