Status:
COMPLETED
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Novartis
Aventis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing ...
Detailed Description
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy
- No more than one prior chemotherapy regimen for metastatic breast cancer
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- Age 18 years or older
- Give written informed consent
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Moderate to severe peripheral neuropathy
- Uncontrolled blood pressure or uncontrolled heart beat irregularities
- Diabetes Mellitus with fasting blood sugar greater than 200 mg %
- Significant heart disease within the prior 6 months
- Severe or uncontrolled medical disease
- Active uncontrolled infection
- Known chronic liver disease
- Known diagnosis of HIV infection
- Pregnant or breast feeding females
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00193180
Start Date
May 1 2005
End Date
January 1 2009
Last Update
May 27 2016
Active Locations (6)
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1
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
2
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
3
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
4
Methodist Cancer Center
Omaha, Nebraska, United States, 68114