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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00072852

Collaborator

(none)

134

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2003

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Mobile	Alabama	United States	36608
2	Pfizer Investigational Site	Anchorage	Alaska	United States	99508
3	Pfizer Investigational Site	Lewistown	Idaho	United States	83501
4	Pfizer Investigational Site	Alton	Illinois	United States	62002
5	Pfizer Investigational Site	Indianapolis	Indiana	United States	46227
6	Pfizer Investigational Site	Overland Park	Kansas	United States	66210
7	Pfizer Investigational Site	Chalmette	Louisiana	United States	70043
8	Pfizer Investigational Site	Covington	Louisiana	United States	70433
9	Pfizer Investigational Site	Mandeville	Louisiana	United States	70448
10	Pfizer Investigational Site	Metairie	Louisiana	United States	70002
11	Pfizer Investigational Site	Metairie	Louisiana	United States	70006
12	Pfizer Investigational Site	New Orleans	Louisiana	United States	70115
13	Pfizer Investigational Site	Boston	Massachusetts	United States	02114
14	Pfizer Investigational Site	Boston	Massachusetts	United States	02115
15	Pfizer Investigational Site	Boston	Massachusetts	United States	02130
16	Pfizer Investigational Site	Detroit	Michigan	United States	48201
17	Pfizer Investigational Site	Southaven	Mississippi	United States	38671
18	Pfizer Investigational Site	Kansas City	Missouri	United States	64111
19	Pfizer Investigational Site	St. Louis	Missouri	United States	63136
20	Pfizer Investigational Site	St. Louis	Missouri	United States	63141
21	Pfizer Investigational Site	Washington	Missouri	United States	63090
22	Pfizer Investigational Site	New Brunswick	New Jersey	United States	08901-2601
23	Pfizer Investigational Site	New Brunswick	New Jersey	United States	08903
24	Pfizer Investigational Site	New York	New York	United States	10021
25	Pfizer Investigational Site	Stony Brook	New York	United States	11794
26	Pfizer Investigational Site	Kettering	Ohio	United States	45409
27	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73120
28	Pfizer Investigational Site	Greenville	South Carolina	United States	29615
29	Pfizer Investigational Site	Covington	Tennessee	United States	38019
30	Pfizer Investigational Site	Franklin	Tennessee	United States	37067
31	Pfizer Investigational Site	Gallatin	Tennessee	United States	37066
32	Pfizer Investigational Site	Hermitage	Tennessee	United States	37076
33	Pfizer Investigational Site	Lebanon	Tennessee	United States	37087
34	Pfizer Investigational Site	Memphis	Tennessee	United States	38120
35	Pfizer Investigational Site	Murfreesboro	Tennessee	United States	37130
36	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
37	Pfizer Investigational Site	Nashville	Tennessee	United States	37205
38	Pfizer Investigational Site	Nashville	Tennessee	United States	37207
39	Pfizer Investigational Site	Nashville	Tennessee	United States	37211
40	Pfizer Investigational Site	Dallas	Texas	United States	75204
41	Pfizer Investigational Site	Dallas	Texas	United States	75230-2510
42	Pfizer Investigational Site	Dallas	Texas	United States	75231
43	Pfizer Investigational Site	Dallas	Texas	United States	75246
44	Pfizer Investigational Site	Fort Worth	Texas	United States	76104
45	Pfizer Investigational Site	Plano	Texas	United States	75075-7787
46	Pfizer Investigational Site	Tyler	Texas	United States	75702
47	Pfizer Investigational Site	Federal Way	Washington	United States	98003
48	Pfizer Investigational Site	Lakewood	Washington	United States	98499
49	Pfizer Investigational Site	Seattle	Washington	United States	98104-2499
50	Pfizer Investigational Site	Seattle	Washington	United States	98104
51	Pfizer Investigational Site	Seattle	Washington	United States	98109-1023
52	Pfizer Investigational Site	Seattle	Washington	United States	98122
53	Pfizer Investigational Site	Seattle	Washington	United States	98195
54	Pfizer Investigational Site	Tacoma	Washington	United States	98405
55	Pfizer Investigational Site	Vancouver	Washington	United States	98684
56	Pfizer Investigational Site	Yakima	Washington	United States	98902
57	Pfizer Investigational Site	Milwaukee	Wisconsin	United States	53215
58	Pfizer Investigational Site	Capital Federal	Buenos Aires	Argentina	1426
59	Pfizer Investigational Site	Rosario	Santa Fe	Argentina	2000
60	Pfizer Investigational Site	Capital Federal		Argentina	1406
61	Pfizer Investigational Site	Cordoba		Argentina	5000
62	Pfizer Investigational Site	Santa Fe		Argentina	3000
63	Pfizer Investigational Site	South Brisbane	Queensland	Australia	4101
64	Pfizer Investigational Site	Frankston	Victoria	Australia	3199
65	Pfizer Investigational Site	Bogota	Bogota DC	Colombia	464
66	Pfizer Investigational Site	Wellington		New Zealand	489

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00072852

Other Study ID Numbers:

CPTAPO-0047-146
A5961023

First Posted:

Nov 13, 2003

Last Update Posted:

Oct 16, 2008

Last Verified:

Oct 1, 2008

Additional relevant MeSH terms:

Breast Neoplasms

Irinotecan

Study Results

No Results Posted as of Oct 16, 2008