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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
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 1, 2005
    Last Updated
    February 9, 2011
    Sponsor
    Hoffmann-La Roche
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    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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