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A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab

Primary Purpose

Colorectal Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
bevacizumab [Avastin]
cetuximab
mFOLFOX6
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:

  • Adult patients >/= 18 years of age
  • Histologically confirmed adenocarcinoma of the colon or rectum
  • Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
  • Tumour tissue sample available for assessment of K-RAS and BRAF genes
  • Prior radiotherapy must have been completed 4 weeks before randomization
  • Adequate bone marrow, kidney and liver function
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

  • Previous chemotherapy for metastatic disease
  • Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
  • Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
  • Clinical or radiographic evidence of brain metastases
  • Clinically significant cardiovascular disease or disorder
  • History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
  • HIV, hepatitis B or C infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    K-RAS mutated

    K-RAS native A

    K-RAS native B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria

    Secondary Outcome Measures

    Overall survival
    Objective response rate
    Safety: Incidence of adverse events
    Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)
    Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms

    Full Information

    First Posted
    April 18, 2011
    Last Updated
    November 1, 2016
    Sponsor
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01338558
    Brief Title
    A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    May 2015 (Anticipated)
    Study Completion Date
    May 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hoffmann-La Roche

    4. Oversight

    5. Study Description

    Brief Summary
    This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    K-RAS mutated
    Arm Type
    Experimental
    Arm Title
    K-RAS native A
    Arm Type
    Experimental
    Arm Title
    K-RAS native B
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    bevacizumab [Avastin]
    Intervention Description
    5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent
    Intervention Type
    Drug
    Intervention Name(s)
    cetuximab
    Intervention Description
    400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent
    Intervention Type
    Drug
    Intervention Name(s)
    mFOLFOX6
    Intervention Description
    Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
    Primary Outcome Measure Information:
    Title
    Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
    Time Frame
    up to 4 years
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    up to 4 years
    Title
    Objective response rate
    Time Frame
    4 years
    Title
    Safety: Incidence of adverse events
    Time Frame
    4 years
    Title
    Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)
    Time Frame
    up to 4 years
    Title
    Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms
    Time Frame
    up to 4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients >/= 18 years of age Histologically confirmed adenocarcinoma of the colon or rectum Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria Tumour tissue sample available for assessment of K-RAS and BRAF genes Prior radiotherapy must have been completed 4 weeks before randomization Adequate bone marrow, kidney and liver function Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: Previous chemotherapy for metastatic disease Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors Clinical or radiographic evidence of brain metastases Clinically significant cardiovascular disease or disorder History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours HIV, hepatitis B or C infection
    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

    Learn more about this trial

    A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab

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