Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital
• Treatments: Paclitaxel; Paclitaxel poliglumex

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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