Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases
NCT ID: NCT00617539
Last Updated: 2018-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2005-02-28
2014-01-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with temozolomide and to see how well it works in treating patients with breast cancer who have received previous treatment for brain metastases.
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Detailed Description
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Primary
* To evaluate the objective response rate systemically and in the CNS to the combination of irinotecan hydrochloride and temozolomide among patients with breast cancer and progressive brain metastases that have progressed after previous treatment for brain metastases.
* To determine the toxicities associated with the combination of irinotecan hydrochloride and temozolomide in breast cancer patients with progressive brain metastases.
Secondary
* To evaluate the time to first progression at any site (CNS or extra-CNS) in patients treated with the combination of irinotecan hydrochloride and temozolomide.
* To evaluate the overall survival of patients treated with the combination of irinotecan hydrochloride and temozolomide for brain metastases.
OUTLINE: Patients receive irinotecan IV on days 1 and 15 and oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 4 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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irinotecan and temozolomide
irinotecan hydrochloride
temozolomide
Interventions
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irinotecan hydrochloride
temozolomide
Eligibility Criteria
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Inclusion Criteria
* No prophylactic use of filgrastim (G-CSF) during first course of treatment
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Michelle Melisko, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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UCSF-05751
Identifier Type: -
Identifier Source: secondary_id
05751
Identifier Type: -
Identifier Source: org_study_id
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