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

NCT ID: NCT00148707

Last Updated: 2007-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-09-30

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 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.

Conditions

Breast Cancer; Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; HER2-negative Breast Cancer; CT-2103; Xyotax

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CT-2103 (Xyotax)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Lawrence N. Shulman, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

04-299

Identifier Type: -

Identifier Source: org_study_id