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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00072852 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Irinotecan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| 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 | |
| St. Louis, Missouri, United States, 63141 | |
| Pfizer Investigational Site | |
| Washington, Missouri, United States, 63090 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63136 | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64111 | |
| 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 | |
| Stony Brook, New York, United States, 11794 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10021 | |
| 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 | |
| Gallatin, Tennessee, United States, 37066 | |
| Pfizer Investigational Site | |
| NASHVILLE, Tennessee, United States, 37211 | |
| Pfizer Investigational Site | |
| Lebanon, Tennessee, United States, 37087 | |
| Pfizer Investigational Site | |
| Murfreesboro, Tennessee, United States, 37130 | |
| Pfizer Investigational Site | |
| Hermitage, Tennessee, United States, 37076 | |
| 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 | |
| Franklin, Tennessee, United States, 37067 | |
| Pfizer Investigational Site | |
| Covington, Tennessee, United States, 38019 | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75204 | |
| Pfizer Investigational Site | |
| Tyler, Texas, United States, 75702 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75230-2510 | |
| Pfizer Investigational Site | |
| Plano, Texas, United States, 75075-7787 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98104-2499 | |
| Pfizer Investigational Site | |
| Lakewood, Washington, United States, 98499 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Pfizer Investigational Site | |
| Federal Way, Washington, United States, 98003 | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98109-1023 | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98195 | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98104 | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98122 | |
| Pfizer Investigational Site | |
| Yakima, Washington, United States, 98902 | |
| Pfizer Investigational Site | |
| Vancouver, Washington, United States, 98684 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Argentina | |
| Pfizer Investigational Site | |
| CAPITAL FEDERAL, Argentina, 1406 | |
| Pfizer Investigational Site | |
| Cordoba, Argentina, 5000 | |
| Pfizer Investigational Site | |
| Santa Fe, Argentina, 3000 | |
| Argentina, Buenos Aires | |
| Pfizer Investigational Site | |
| CAPITAL FEDERAL, Buenos Aires, Argentina, 1426 | |
| Argentina, Santa Fe | |
| Pfizer Investigational Site | |
| Rosario, Santa Fe, Argentina, 2000 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| South Brisbane, Queensland, Australia, 4101 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Frankston, Victoria, Australia, 3199 | |
| Colombia, Bogota DC | |
| Pfizer Investigational Site | |
| Bogota, Bogota DC, Colombia, 464 | |
| New Zealand | |
| Pfizer Investigational Site | |
| Wellington, New Zealand, 489 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | CPTAPO-0047-146, A5961023 |
| Study First Received: | November 11, 2003 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00072852 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Breast Neoplasms |
Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Phytogenic Breast Diseases |
