Clinical trial NCT00072852: Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-11-13
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Anchorage
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Lewistown
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Alton
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Chalmette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Mandeville
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Southaven
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Washington
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Gallatin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Yakima
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Santa Fe
country: Argentina
facility: Pfizer Investigational Site
city: South Brisbane
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Frankston
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Bogota DC
city: Wellington
country: New Zealand
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: