A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer
1 other identifier
interventional
435
0 countries
N/A
Brief Summary
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m\^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m\^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m\^2 po bid on Days 1-7, oxaliplatin 85 mg/m\^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2005
CompletedStudy Start
First participant enrolled
July 1, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedResults Posted
Study results publicly available
March 3, 2011
CompletedMarch 3, 2011
February 1, 2011
3.8 years
July 1, 2005
April 25, 2010
February 9, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).
Time to disease progression or death (through follow-up phase)
Secondary Outcomes (3)
Overall Survival
Time to death (through follow-up phase): Approximate Median of 718 days
Best Overall Clinical Response
Through follow-up phase: Approximate Median of 318 days
Duration of Overall Clinical Response (CR or PR)
Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Metastatic or inoperable locally advanced colorectal cancer
- \>=1 measurable target lesion
You may not qualify if:
- Previous systemic therapy for advanced or metastatic disease
- Previous treatment with bevacizumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 1, 2005
First Posted
July 12, 2005
Study Start
July 1, 2005
Primary Completion
April 1, 2009
Last Updated
March 3, 2011
Results First Posted
March 3, 2011
Record last verified: 2011-02