Clinical trial NCT00642603: A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
Official title: A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 41
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 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥18 years of age
* Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
* ≥1 measurable target lesion
* Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Exclusion Criteria:

* Prior systemic therapy for advanced or metastatic disease
* History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
* Clinically significant cardiovascular disease
* Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
* Chronic daily treatment with \>325 mg/day aspirin

Primary outcomes:
measure: Progression-free Survival (PFS) in U.S. Patients Only
timeFrame: From first patient enrolled up to approximately 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: PARK Springs
country: United States
state: Arizona
city: Sedona
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Colton
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Modesto
country: United States
state: California
city: Montebello
country: United States
state: California
city: Pomona
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Lake Worth
country: United States
state: Florida
city: Miami Shores
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ocoee
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Niles
country: United States
state: Illinois
city: Paducah
country: United States
state: Kentucky
city: Alexandria
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Westminster
country: United States
state: Maryland
city: Pittsfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Jefferson City
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Neptune
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Santa Fe
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Huntington Station
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Ephrata
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Florence
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Cookeville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Arlington
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Garland
country: United States
state: Texas
city: Lewisville
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: Paris
country: United States
state: Texas
city: Round Rock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Christiansburg
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: