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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00148707

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Metastatic Breast Cancer	Drug: CT-2103 (Xyotax)	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Poliglumex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.

Secondary Outcome Measures:

To evaluate the side effects of CT-2103 in patients with metastatic breast cancer
to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months
to determine the time to progression and overall survival of patients treated with CT2103.

Estimated Enrollment:	45
Study Start Date:	October 2004
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148707

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator:

Lawrence N. Shulman, MD

Dana-Farber Cancer Institute

More Information

Study ID Numbers:	04-299
Study First Received:	September 7, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00148707
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009