Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

October 15, 2008 updated by: Pfizer

Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina, 1406
        • Pfizer Investigational Site
      • Cordoba, Argentina, 5000
        • Pfizer Investigational Site
      • Santa Fe, Argentina, 3000
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Pfizer Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Pfizer Investigational Site
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Pfizer Investigational Site
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Pfizer Investigational Site
  • Colombia
    • Bogota DC
      • Bogota, Bogota DC, Colombia, 464
        • Pfizer Investigational Site
  • New Zealand
      • Wellington, New Zealand, 489
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Pfizer Investigational Site
    • Idaho
      • Lewistown, Idaho, United States, 83501
        • Pfizer Investigational Site
    • Illinois
      • Alton, Illinois, United States, 62002
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
    • Louisiana
      • Chalmette, Louisiana, United States, 70043
        • Pfizer Investigational Site
      • Covington, Louisiana, United States, 70433
        • Pfizer Investigational Site
      • Mandeville, Louisiana, United States, 70448
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70002
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02130
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63136
        • Pfizer Investigational Site
      • Washington, Missouri, United States, 63090
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States, 08901-2601
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • Stony Brook, New York, United States, 11794
        • Pfizer Investigational Site
    • Ohio
      • Kettering, Ohio, United States, 45409
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Pfizer Investigational Site
    • Tennessee
      • Covington, Tennessee, United States, 38019
        • Pfizer Investigational Site
      • Franklin, Tennessee, United States, 37067
        • Pfizer Investigational Site
      • Gallatin, Tennessee, United States, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, United States, 37076
        • Pfizer Investigational Site
      • Lebanon, Tennessee, United States, 37087
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230-2510
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75204
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75075-7787
        • Pfizer Investigational Site
      • Tyler, Texas, United States, 75702
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, United States, 98003
        • Pfizer Investigational Site
      • Lakewood, Washington, United States, 98499
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98122
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98195
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98104-2499
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98109-1023
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
      • Vancouver, Washington, United States, 98684
        • Pfizer Investigational Site
      • Yakima, Washington, United States, 98902
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with diagnosis of primary adenocarcinoma of the breast
  • Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
  • At least one measurable lesion >20mm (or >10 mm with spiral CT scan)
  • Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
  • Women at least 18 years old, with performance status 0-2

Exclusion Criteria:

  • Prior treatment with another topoisomerase I inhibitor
  • Current enrollment in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

November 11, 2003

First Submitted That Met QC Criteria

November 12, 2003

First Posted (Estimate)

November 13, 2003

Study Record Updates

Last Update Posted (Estimate)

October 16, 2008

Last Update Submitted That Met QC Criteria

October 15, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPTAPO-0047-146
  • A5961023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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