Breast Neoplasms Clinical Trial
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
| Verified date | October 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 134 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Capital Federal | |
| Argentina | Pfizer Investigational Site | Capital Federal | Buenos Aires |
| Argentina | Pfizer Investigational Site | Cordoba | |
| Argentina | Pfizer Investigational Site | Rosario | Santa Fe |
| Argentina | Pfizer Investigational Site | Santa Fe | |
| Australia | Pfizer Investigational Site | Frankston | Victoria |
| Australia | Pfizer Investigational Site | South Brisbane | Queensland |
| Colombia | Pfizer Investigational Site | Bogota | Bogota DC |
| New Zealand | Pfizer Investigational Site | Wellington | |
| United States | Pfizer Investigational Site | Alton | Illinois |
| United States | Pfizer Investigational Site | Anchorage | Alaska |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Chalmette | Louisiana |
| United States | Pfizer Investigational Site | Covington | Louisiana |
| United States | Pfizer Investigational Site | Covington | Tennessee |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Federal Way | Washington |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Franklin | Tennessee |
| United States | Pfizer Investigational Site | Gallatin | Tennessee |
| United States | Pfizer Investigational Site | Greenville | South Carolina |
| United States | Pfizer Investigational Site | Hermitage | Tennessee |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | Lakewood | Washington |
| United States | Pfizer Investigational Site | Lebanon | Tennessee |
| United States | Pfizer Investigational Site | Lewistown | Idaho |
| United States | Pfizer Investigational Site | Mandeville | Louisiana |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Mobile | Alabama |
| United States | Pfizer Investigational Site | Murfreesboro | Tennessee |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Plano | Texas |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Southaven | Mississippi |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Stony Brook | New York |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Tyler | Texas |
| United States | Pfizer Investigational Site | Vancouver | Washington |
| United States | Pfizer Investigational Site | Washington | Missouri |
| United States | Pfizer Investigational Site | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Australia, Colombia, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the safety and efficacy of Irinotecan in refractory breast cancer. |
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