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Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thalidomide
Capecitabine
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic breast cancer confirmed by biopsy Measurable or evaluable disease Females > 18 years Able to perform activities of daily living with minimal assistance Life expectancy > 3 months Adequate bone marrow, liver and kidney function All patients must give written informed consent in order to participate. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Women who are pregnant or lactating. Received more than 3 prior chemotherapy regimens in the metastatic setting. Received continuous infusion 5-fluorouracil lasting > 120 hours. Received thalidomide or capecitabine as their last prior regimen. Preexisting moderate to severe neuropathy 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

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    May 2, 2011
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Celgene Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193102
    Brief Title
    Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
    Official Title
    Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    February 2005 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Celgene Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.
    Detailed Description
    Upon determination of eligibility, patients will be receive: Thalidomide + Capecitebine

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Thalidomide
    Intervention Description
    Thalidomide
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine
    Intervention Description
    Capecitabine
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Time Frame
    18 Months

    10. Eligibility

    Sex
    Female
    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: Metastatic breast cancer confirmed by biopsy Measurable or evaluable disease Females > 18 years Able to perform activities of daily living with minimal assistance Life expectancy > 3 months Adequate bone marrow, liver and kidney function All patients must give written informed consent in order to participate. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Women who are pregnant or lactating. Received more than 3 prior chemotherapy regimens in the metastatic setting. Received continuous infusion 5-fluorouracil lasting > 120 hours. Received thalidomide or capecitabine as their last prior regimen. Preexisting moderate to severe neuropathy 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
    Howard Burris, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20210519
    Citation
    Burris HA 3rd, Jones SF, Shipley D, Meluch AA, Greco FA, Barton JH, Yardley DA, Hainsworth JD. Phase II study of capecitabine in combination with thalidomide in patients with metastatic breast cancer. Cancer Invest. 2010 May;28(4):408-12. doi: 10.3109/07357901003631049.
    Results Reference
    result

    Learn more about this trial

    Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer

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