ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
This study has been terminated.
(This study has closed to accrual early due to slow accrual.)
Brigham and Women's Hospital
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute
First received: July 3, 2007
Last updated: March 12, 2013
Last verified: March 2013
The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases
Primary Outcome Measures:
Secondary Outcome Measures:
- Number of Subjects With Adverse Events (Any Grade) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Adverse events per NCI CTCAE
- Objective Response Rate in Non-Central Nervous System (CNS) Sites [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
- Time to Progression at Any Site. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0
- Clinical Benefit Rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
Given intravenously over approximately 30 minutes once every 3 weeks
- Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.
- During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.
- At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.
- After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.
- At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
- Measurable Central Nervous System (CNS) disease, as defined as at least one lesion > or equal too 10mm in longest dimension
- New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
- Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
- No increase in corticosteroid use in the week prior to study entry
- Any number prior lines of chemotherapy for metastatic breast cancer
- 18 years of age of older
- Life expectancy of greater than 12 weeks
- ECOG Performance Status 0-2
- Patients must have normal organ function as outlined in the protocol
- Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
- Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
- Patients may not be receiving any other investigational agent
- Patients may not be receiving any cancer-directed therapy
- Prior treatment with investigational chemotherapy for brain metastases
- Prior treatment with epothilone for metastatic breast cancer
- Leptomeningeal carcinomatosis as the only site of CNS involvement.
- Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine
- More than 2 seizures over the last four weeks prior to study entry
- Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00496379
|Dana-Farber Cancer Institute
|Boston, Massachusetts, United States, 02115 |
Nancy Lin, MD
Brigham and Women's Hospital
Breast Cancer Research Foundation
||Nancy Lin, MD
||Dana-Farber Cancer Institute
No publications provided
||Nancy Lin, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 3, 2007
|Results First Received:
||November 30, 2012
||March 12, 2013
||United States: Food and Drug Administration
Keywords provided by Dana-Farber Cancer Institute:
metastatic breast cancer
invasive breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Central Nervous System Diseases
Neoplasms by Site
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms