Status:
COMPLETED
Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Breast Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.
Detailed Description
* Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed. * Prior to each...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of invasive breast cancer, Stage IV disease
- Age greater than 18 years
- At least one measurable target lesion as defined by RECIST that has not been previously treated with local therapy
- HER2-negative breast cancer
- Up to one prior chemotherapy for advanced or metastatic disease
- ECOG performance status 0-1
- Life expectancy \> 12 weeks
- Adequate liver and bone marrow function: AST \< 2.5 x ULN; Bilirubin \< 1.5 x ULN; ANC \> 1,500/ul; platelet count \> 100,000/ul; normal PT and PTT
- At least 2 weeks since prior radiation and recovered from treatment-related toxicity
Exclusion
- Prior taxanes for treatment of metastatic disease
- Pregnant of breast-feeding women
- HER2-positive breast cancer
- More than 1 prior chemotherapy regimen for metastatic disease
- Untreated brain metastases
- Concurrent radiotherapy or investigational drug
- Prior bone marrow or stem cell transplant
- History of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer
- Uncontrolled infection
- Active bleeding, or history of bleeding requiring transfusion
- Active cardiac disease
- Serious medical or psychiatric illness
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00148707
Start Date
October 1 2004
End Date
September 1 2007
Last Update
December 21 2007
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115