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

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ClinicalTrials.gov Identifier: NCT00072852
Recruitment Status : Completed
First Posted : November 13, 2003
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Irinotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
Study Start Date : November 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072852


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Locations
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United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Alaska
Pfizer Investigational Site
Anchorage, Alaska, United States, 99508
United States, Idaho
Pfizer Investigational Site
Lewistown, Idaho, United States, 83501
United States, Illinois
Pfizer Investigational Site
Alton, Illinois, United States, 62002
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46227
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66210
United States, Louisiana
Pfizer Investigational Site
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, 70002
Pfizer Investigational Site
Metairie, Louisiana, United States, 70006
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02130
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Mississippi
Pfizer Investigational Site
Southaven, Mississippi, United States, 38671
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64111
Pfizer Investigational Site
St. Louis, Missouri, United States, 63136
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
Pfizer Investigational Site
Washington, Missouri, United States, 63090
United States, New Jersey
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08901-2601
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
Stony Brook, New York, United States, 11794
United States, Ohio
Pfizer Investigational Site
Kettering, Ohio, United States, 45409
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29615
United States, Tennessee
Pfizer Investigational Site
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
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75204
Pfizer Investigational Site
Dallas, Texas, United States, 75230-2510
Pfizer Investigational Site
Dallas, Texas, United States, 75231
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
United States, Washington
Pfizer Investigational Site
Federal Way, Washington, United States, 98003
Pfizer Investigational Site
Lakewood, Washington, United States, 98499
Pfizer Investigational Site
Seattle, Washington, United States, 98104-2499
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Pfizer Investigational Site
Seattle, Washington, United States, 98109-1023
Pfizer Investigational Site
Seattle, Washington, United States, 98122
Pfizer Investigational Site
Seattle, Washington, United States, 98195
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
Pfizer Investigational Site
Vancouver, Washington, United States, 98684
Pfizer Investigational Site
Yakima, Washington, United States, 98902
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215
Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, 1426
Pfizer Investigational Site
Rosario, Santa Fe, Argentina, 2000
Pfizer Investigational Site
Capital Federal, Argentina, 1406
Pfizer Investigational Site
Cordoba, Argentina, 5000
Pfizer Investigational Site
Santa Fe, Argentina, 3000
Australia, Queensland
Pfizer Investigational Site
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Pfizer Investigational Site
Frankston, Victoria, Australia, 3199
Colombia
Pfizer Investigational Site
Bogota, Bogota DC, Colombia, 464
New Zealand
Pfizer Investigational Site
Wellington, New Zealand, 489
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00072852     History of Changes
Other Study ID Numbers: CPTAPO-0047-146
A5961023
First Posted: November 13, 2003    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Irinotecan
Taxane
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors