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Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Primary Purpose

Neoplasms, Unknown Primary

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bevacizumab
Erlotinib
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Unknown Primary

Eligibility Criteria

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

Inclusion Criteria: To be included in this study, you must meet the following criteria: Carcinoma of unknown primary site confirmed by biopsy Measurable disease ECOG performance status must be 0-1 Adequate bone marrow, liver and kidney Understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age< 18 years May not have received EGFR inhibitors History of acute myocardial infarction within 6 months Clinically significant cardiovascular disease Moderate to severe peripheral vascular disease. History of stroke within 6 months History of abdominal fistula, perforation, or abscess within 6 months Active concurrent infections Serious underlying medical conditions Active brain metastases Women who are pregnant or lactating. PEG or G-tube Proteinuria Any nonhealing wound, ulcer, or bone fracture. Any clinical evidence or history of bleeding, clotting or coagulopathy Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Overall response rate

    Secondary Outcome Measures

    Time to progression
    Overall survival
    Overall tolerability
    Overall toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    September 15, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193622
    Brief Title
    Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
    Official Title
    A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    September 2005 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.
    Detailed Description
    Upon determination of eligibility, patients will be receive: Bevacizumab + Erlotinib

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Unknown Primary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Erlotinib
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Secondary Outcome Measure Information:
    Title
    Time to progression
    Title
    Overall survival
    Title
    Overall tolerability
    Title
    Overall toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Carcinoma of unknown primary site confirmed by biopsy Measurable disease ECOG performance status must be 0-1 Adequate bone marrow, liver and kidney Understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age< 18 years May not have received EGFR inhibitors History of acute myocardial infarction within 6 months Clinically significant cardiovascular disease Moderate to severe peripheral vascular disease. History of stroke within 6 months History of abdominal fistula, perforation, or abscess within 6 months Active concurrent infections Serious underlying medical conditions Active brain metastases Women who are pregnant or lactating. PEG or G-tube Proteinuria Any nonhealing wound, ulcer, or bone fracture. Any clinical evidence or history of bleeding, clotting or coagulopathy Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17470864
    Citation
    Hainsworth JD, Spigel DR, Farley C, Thompson DS, Shipley DL, Greco FA; Minnie Pearl Cancer Research Network. Phase II trial of bevacizumab and erlotinib in carcinomas of unknown primary site: the Minnie Pearl Cancer Research Network. J Clin Oncol. 2007 May 1;25(13):1747-52. doi: 10.1200/JCO.2006.09.3047.
    Results Reference
    result

    Learn more about this trial

    Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

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