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A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Avastin
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic Colorectal Cancer OASIS

Eligibility Criteria

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

Inclusion Criteria: Signed Informed Consent Form Metastatic or locally advanced and unresectable colorectal cancer Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) Age >= 18 years ECOG performance status of 0 or 1 Adequate hematologic, hepatic, and renal function at the time of study entry to begin prescribed study therapy, according to institutional guidelines Use of an effective form of contraception during the study (for subjects of childbearing potential and their partners) Exclusion Criteria: Prior treatment with Avastin Hypersensitivity to any of the study drugs or ingredients Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study History of any other malignancy (except squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that has been effectively treated) unless in complete remission and off all therapy for that malignancy for at least 5 years Known brain or central nervous system metastases Prior treatment for advanced or metastatic colorectal cancer Prior treatment with an anti-angiogenesis agent, in either the adjuvant or metastatic setting Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrollment) Medical or psychiatric disorders that would interfere with informed consent or compliance, or would render the subject at high risk for participation in this study and its follow-up procedures Active infection requiring antibiotics on Day 1 New York Heart Association (NYHA) Grade II or greater CHF Evidence of bleeding diathesis or coagulopathy Grade > 1 peripheral neuropathy (as defined by the NCI CTCAE, v3.0) Lack of physical integrity of the upper gastrointestinal tract or history of malabsorption syndrome Blood pressure > 150/100 mmHg Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1; anticipation of need for a major surgical procedure during the course of the study Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 1 Urine protein:creatinine ratio >= 1.0 at screening History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 Serious, non-healing wound, ulcer, or bone fracture History of myocardial infarction within 6 months prior to Day 1 Unstable angina Clinically significant peripheral vascular disease History of stroke within 6 months prior to Day 1 Pregnancy (positive pregnancy test) or lactation

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To compare the efficacy, as measured by progression-free survival (PFS), of FOLFOX/Avastin followed by FOLFIRI/Avastin versus FOLFOX/Avastin followed by 5-FU/LV/Avastin as first-line therapy for previously untreated metastatic colorectal cancer.

    Secondary Outcome Measures

    To evaluate the tolerability of sequential treatment in subjects and to evaluate the safety of an irinotecan/Avastin-based regimen versus a 5-FU/Avastin regimen for previously untreated metastatic colorectal cancer.

    Full Information

    First Posted
    June 20, 2005
    Last Updated
    May 26, 2006
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00114946
    Brief Title
    A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer
    Official Title
    A Randomized, Open-Label Trial Comparing Two Avastin (Bevacizumab)-Based Treatment Regimens for the First-Line Treatment of Metastatic Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Terminated
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2007 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a randomized, open-label, active-control, multicenter trial comparing two oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal cancer. The study is designed to compare the efficacy of these two treatment sequences with respect to progression free survival (PFS) and overall survival.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Metastatic Colorectal Cancer OASIS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Enrollment
    800 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Avastin
    Primary Outcome Measure Information:
    Title
    To compare the efficacy, as measured by progression-free survival (PFS), of FOLFOX/Avastin followed by FOLFIRI/Avastin versus FOLFOX/Avastin followed by 5-FU/LV/Avastin as first-line therapy for previously untreated metastatic colorectal cancer.
    Secondary Outcome Measure Information:
    Title
    To evaluate the tolerability of sequential treatment in subjects and to evaluate the safety of an irinotecan/Avastin-based regimen versus a 5-FU/Avastin regimen for previously untreated metastatic colorectal cancer.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed Informed Consent Form Metastatic or locally advanced and unresectable colorectal cancer Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) Age >= 18 years ECOG performance status of 0 or 1 Adequate hematologic, hepatic, and renal function at the time of study entry to begin prescribed study therapy, according to institutional guidelines Use of an effective form of contraception during the study (for subjects of childbearing potential and their partners) Exclusion Criteria: Prior treatment with Avastin Hypersensitivity to any of the study drugs or ingredients Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study History of any other malignancy (except squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that has been effectively treated) unless in complete remission and off all therapy for that malignancy for at least 5 years Known brain or central nervous system metastases Prior treatment for advanced or metastatic colorectal cancer Prior treatment with an anti-angiogenesis agent, in either the adjuvant or metastatic setting Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrollment) Medical or psychiatric disorders that would interfere with informed consent or compliance, or would render the subject at high risk for participation in this study and its follow-up procedures Active infection requiring antibiotics on Day 1 New York Heart Association (NYHA) Grade II or greater CHF Evidence of bleeding diathesis or coagulopathy Grade > 1 peripheral neuropathy (as defined by the NCI CTCAE, v3.0) Lack of physical integrity of the upper gastrointestinal tract or history of malabsorption syndrome Blood pressure > 150/100 mmHg Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1; anticipation of need for a major surgical procedure during the course of the study Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 1 Urine protein:creatinine ratio >= 1.0 at screening History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 Serious, non-healing wound, ulcer, or bone fracture History of myocardial infarction within 6 months prior to Day 1 Unstable angina Clinically significant peripheral vascular disease History of stroke within 6 months prior to Day 1 Pregnancy (positive pregnancy test) or lactation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary Sugrue, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer

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