ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

NCT00496379 | Terminated Phase 2 Results

• 1 other identifier: 06-268
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; CNS Disease

Keywords

metastatic breast cancer; invasive breast cancer; brain metastases; ZK-EPO

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate in the Central Nervous System (CNS)

  Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.

  2 years

Secondary Outcomes (4)

• Number of Subjects With Adverse Events (Any Grade)

  2 years

• Objective Response Rate in Non-Central Nervous System (CNS) Sites

  2 years

• Time to Progression at Any Site.

  2 years

• Clinical Benefit Rate.

  2 years

Study Arms (1)

ZK219477

EXPERIMENTAL

Drug: ZK219477

Interventions

ZK219477 DRUG

Given intravenously over approximately 30 minutes once every 3 weeks

Also known as: ZK-EPO, ZK-Epothilone, Sagopilone

ZK219477

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nancy Lin, MD: lead
• Brigham and Women's Hospital: collaborator
• Bayer: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Central Nervous System Diseases; Brain Neoplasms

Interventions

sagopilone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases

Results Point of Contact

• Title: Dr. Nancy Lin
• Organization: Dana-Farber Cancer Institute

nlin@partners.org

617-632-2335

Study Officials

• Nancy Lin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2012
• Last Updated: March 14, 2013
• Results First Posted: March 12, 2013

Record last verified: 2013-03

Locations

US (1)