A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases
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|ClinicalTrials.gov Identifier: NCT01939483|
Recruitment Status : Withdrawn (Slow accrual)
First Posted : September 11, 2013
Last Update Posted : October 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Metastases Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Drug: irinotecan hydrochloride Other: laboratory biomarker analysis||Not Applicable|
PRIMARY OBJECTIVES; I. To evaluate the safety and efficacy of irinotecan (irinotecan hydrochloride) in breast cancer patients with brain metastases who progressed after radiation therapy.
II. To estimate central nervous system (CNS) objective response and clinical benefit rate in patients with breast cancer and brain metastases treated with irinotecan.
III. To estimate progression free survival. IV. To estimate overall survival. V. To assess the toxicity of Irinotecan.
Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1, 8, 15, 22, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2018|
Experimental: Treatment (irinotecan hydrochloride)
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1, 8, 15, 22, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
This arm also includes laboratory biomarker analysis as an intervention.
Drug: irinotecan hydrochloride
Other: laboratory biomarker analysis
- CNS objective response (complete response or partial response), defined as at least 20% volumetric reduction of CNS lesions in absence of increasing steroid use, progressive neurologic signs and symptoms, or progressive extra-CNS disease, based on MRI [ Time Frame: Up to 24 months ]
- Response rate of patients who have remained progression-free, based on MRI [ Time Frame: Up to 6 months ]
- Overall survival [ Time Frame: Time between treatment initiation and death, assessed up to 24 months ]The product limit estimator developed by Kaplan and Meier was used to graphically describe the distribution of survival among patients with recurrent disease.
- Progression free survival (PFS) [ Time Frame: Time between treatment initiation and disease progression/relapse/death, assessed up to 24 months ]The product limit estimator developed by Kaplan and Meier was used to graphically describe the distribution of PFS among patients with recurrent disease.
- Clinical benefit rate (objective response + stable disease at least 16 weeks) [ Time Frame: Up to 24 months ]
- Frequency of toxicity occurrence, assessed by National Cancer Institute's Common Terminology Criteria (CTC) for Adverse Events version 4.0 [ Time Frame: Up to 24 months ]Tabulated by type, and worst grade experienced by the patient. Toxicity will initially be summarized within each cohort or patient subgroup, and then collectively summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939483
|Principal Investigator:||Rita Mehta, MD||University of California, Irvine|