Clinical trial NCT00625651: Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
Official title: A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Colorectal Cancer
Colon Cancer
Colorectal Cancer
Rectal Cancer
Keywords: Colon Cancer
Colorectal Cancer
Rectal Cancer
AMG 655
Bevacizumab
Modified FOLFOX6
mFOLFOX6
FOLFOX
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 202
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 phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).

The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
* Subjects with measurable or unmeasurable disease
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Men or women at least 18 years of age
* Adequate hematologic, renal, hepatic and coagulation function

Exclusion Criteria:

* History or known presence of central nervous system (CNS) metastases
* Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
* Any investigational agent or therapy for advanced or metastatic CRC
* Clinically significant cardiac disease
* Clinically significant peripheral neuropathy
* Active inflammatory bowel disease
* Recent gastrointestinal ulcer or hemorrhage
* Recent arterial thrombotic event or pulmonary embolus
* Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
* Recent major surgical procedure or not yet recovered from major surgery

Primary outcomes:
measure: Progression-free survival
timeFrame: Length of study
Secondary outcomes:
measure: Objective response rate
timeFrame: Length of study
measure: Duration of response
timeFrame: Length of study
measure: Time-to-response
timeFrame: Length of study
measure: Overall survival
timeFrame: Length of study
measure: AMG 655 pharmacokinetic parameters
timeFrame: Length of study
measure: The incidence of anti-AMG 655 antibody formation
timeFrame: Length of study
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Downey
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Loma Linda
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Kissimmee
country: United States
facility: Research Site
state: Florida
city: Leesburg
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Lawrenceville
country: United States
facility: Research Site
state: Georgia
city: Harvey
country: United States
facility: Research Site
state: Illinois
city: Maywood
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: St. Joseph
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Great Falls
country: United States
facility: Research Site
state: Montana
city: Long Branch
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Bronx
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Hudson
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Burlington
country: United States
facility: Research Site
state: North Carolina
city: Gastonia
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Middletown
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Harrisburg
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pottsville
country: United States
facility: Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Richardson
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Vancouver
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Fuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1.