A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
capecitabine
Oxaliplatin
bevacizumab
capecitabine
Oxaliplatin
bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: Metastatic or inoperable locally advanced colorectal cancer >=1 measurable target lesion Exclusion Criteria: Previous systemic therapy for advanced or metastatic disease Previous treatment with bevacizumab
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death, for any cause.
Best Overall Clinical Response
Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
Duration of Overall Clinical Response (CR or PR)
Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00118755
Brief Title
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
435 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
850 mg/m^2 po bid on Days 1-14 of each 3-week cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m^2 IV on Day 1 of each 3-week cycle
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
7.5 mg/kg IV on Day 1 of each 3-week cycle
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85 mg/m^2 IV on Day 1 of each 2-week cycle
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
5 mg/kg IV on Day 1 of each 2-week cycle
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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 Frame
Time to disease progression or death (through follow-up phase)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from the date of randomization to the date of death, for any cause.
Time Frame
Time to death (through follow-up phase): Approximate Median of 718 days
Title
Best Overall Clinical Response
Description
Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
Time Frame
Through follow-up phase: Approximate Median of 318 days
Title
Duration of Overall Clinical Response (CR or PR)
Description
Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.
Time Frame
Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic or inoperable locally advanced colorectal cancer
>=1 measurable target lesion
Exclusion Criteria:
Previous systemic therapy for advanced or metastatic disease
Previous treatment with bevacizumab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.roche-trials.com/studyResultGet.action?studyResultNumber=ML18491
Description
Clinical Study Report Synopsis
Learn more about this trial
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
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