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

NCT00072852 | Completed Phase 2

• 2 other identifiers: CPTAPO-0047-146A5961023
• Study Type: interventional
• Target: 134
• Locations: 5 countries
• Sites: 66

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

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

Interventions

Irinotecan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (66)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

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Anchorage, Alaska, 99508, United States

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Lewistown, Idaho, 83501, United States

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Alton, Illinois, 62002, United States

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Indianapolis, Indiana, 46227, United States

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Overland Park, Kansas, 66210, United States

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Chalmette, Louisiana, 70043, United States

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Covington, Louisiana, 70433, United States

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Mandeville, Louisiana, 70448, United States

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Metairie, Louisiana, 70002, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70115, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02130, United States

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Detroit, Michigan, 48201, United States

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Southaven, Mississippi, 38671, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63136, United States

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St Louis, Missouri, 63141, United States

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Washington, Missouri, 63090, United States

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New Brunswick, New Jersey, 08901-2601, United States

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New Brunswick, New Jersey, 08903, United States

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New York, New York, 10021, United States

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Stony Brook, New York, 11794, United States

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Kettering, Ohio, 45409, United States

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Oklahoma City, Oklahoma, 73120, United States

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Greenville, South Carolina, 29615, United States

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Covington, Tennessee, 38019, United States

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Franklin, Tennessee, 37067, United States

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Gallatin, Tennessee, 37066, United States

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Hermitage, Tennessee, 37076, United States

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Lebanon, Tennessee, 37087, United States

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Memphis, Tennessee, 38120, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37207, United States

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Nashville, Tennessee, 37211, United States

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Dallas, Texas, 75204, United States

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Dallas, Texas, 75230-2510, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76104, United States

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Plano, Texas, 75075-7787, United States

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Tyler, Texas, 75702, United States

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Federal Way, Washington, 98003, United States

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Lakewood, Washington, 98499, United States

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Seattle, Washington, 98104-2499, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98109-1023, United States

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Seattle, Washington, 98122, United States

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Seattle, Washington, 98195, United States

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Tacoma, Washington, 98405, United States

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Vancouver, Washington, 98684, United States

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Yakima, Washington, 98902, United States

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Milwaukee, Wisconsin, 53215, United States

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Capital Federal, Buenos Aires, 1426, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Santa Fe, Santa Fe Province, 3000, Argentina

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Capital Federal, 1406, Argentina

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South Brisbane, Queensland, 4101, Australia

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Frankston, Victoria, 3199, Australia

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Bogotá, Bogota DC, 464, Colombia

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Wellington, 489, New Zealand

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 11, 2003
• First Posted: November 13, 2003
• Study Start: November 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: October 16, 2008

Record last verified: 2008-10

Locations

AR (5); US (57); AU (2); CO (1); NZ (1)