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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Metastatic Breast Cancer

Treatments

Drug: CT-2103 (Xyotax)

Study type

Interventional

Funder types

Other

Identifiers

NCT00148707

04-299

Details and patient eligibility

About

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.

Full 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 injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
Additional blood work will be performed once per week after the first two doses of CT-2103.
The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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